Trabajos clinical trial en Orange, New JerseyCrear alertas

The (Senior) Medical Director (MD) - will provide strategic leadership to develop Clinical Development Plan (CDP), working closely with partners in Pre-Clinical, Regulatory, Safety, Stats, & Project Management. Core responsibilities will encompass developing & implementing the Clinical Development Plan and providing leadership to new product development from IND to submission. In addition, the position will ensure program consistency & alignment across studies, working closely with cross functional teams for achieving project goals, within timelines & with high quality. Candidate must possess passion for science and patients, as well as entrepreneurial drive along with strong hands-on experience to help the organization succeed. MAJOR RESPONSIBILITIES AND DUTIE • SProvide clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical progra, • mDesign Comprehensive Development Plans (CDPs), clinical trials and protocols and execute in accordance with applicable Good Clinical Practice (GCP) regulations, • .Lead high quality planning and execution of external meetings and internal stakeholder meetings (e.g., IMs, Governance, DMCs, SSC, Regulatory Authority meetings, etc., • )Define project timelines & deliverable, working closely with cross functional team and assure that deliverable is completed on time, on budget and according to the highest quality, ethical and professional standards, • .Identify project risks with input from the cross functional teams, and support resolving issues, • .Provide therapeutic area medical and scientific expertise to study teams and key stakeholders, • .Anticipate trends in medicine and industry that may/will have an impact on the clinical/commercial viability of products and factors into planning, • .Engage and inspire the project/clinical development team through communicating the strategic vision and the operational plan to achieve the vision, • .Lead & author relevant sections of INDs, Investigator Brochures, Protocols, CTAs, BLA, ISS, ISEs and clinical expert reports with high quality, • .Interact with Regulatory authorities (FDA, EMA etc.) at type C, B, pre-BLA/MAA meetings, Advisory Committee meetings, or other scientific advice forums, • .Performs all duties in keeping with the company’s core values, policies and all applicable regulations, • .Ensure data review quality (e.g. patient eligibility, Protocol Deviation review, efficacy and safety review) and data accuracy, • .Conduct safety review and safety follow up, • .Interpret data and ensure CSR quality/Briefing book quality, • .Interact with the HA and IRB/EC and Answers to medical questions raised by EC/IRBs and sites; identify the need of protocol amendment and maintain appropriate compliance with protocols, • .Interact with the participant Principle Investigators on protocols, • .Conduct literature research and competitive intelligence tracking for assigned projects . QUALIFICATIO • NSMD or equivalent medical degree is required in addition to advanced knowledge and clinical training in medical/scientific are, • a;5 or more years of pharmaceutical experience in Clinical Development for (Senior) Medical Directo, • r.Experience in an academic clinical research or industry environment spanning clinical activities in Phases I through IV require, • d.Knowledge of Oncology is required, with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) and proven ability to understand and interpret basic and clinical scientific research repor, • tsKnowledge of GCP, clinical trial design, statistics, and regulatory and clinical development process, • esExcellent leadership & organizational skills, analytical skills, presentation skills, and strong experience in translating important data into clinical strategie, • s.Experience in biotech is preferre, • d.Willingness to “roll up the sleeves” to contribute to team efforts in a dynamic, fast-paced environmen, • t.Demonstrated ability to build effective working relationships, influence, negotiate, and drive organizational engagemen, • t.Ability to be flexible and adapt quickly to the changing needs of the organizatio, • n.Superior interpersonal skills, & communication skills ensuring full alignment of cross functional team, • s.Highly collaborative & effective influencing skills and the ability to operate across multiple geographie s.

The Director/Senior Director, Product Safety and Pharmacovigilance is a highly scientific and mid-level leadership role that requires medical and safety expertise as the Product Safety and Pharmacovigilance representative on the product clinical development team. In addition, he/she manages and conducts ongoing safety surveillance for assigned products. Also, oversees the preparation of NDA safety updates, IND safety reports, investigator communications, product labeling/package inserts and other periodic safety reports as necessary. Additionally, he/she collaborates with cross-functional groups and other regional safety counterparts to update them on medical assessment, safety signal detection, and risk management practices in the US and international markets. The candidate will have broad knowledge and perspective of drug safety in pharmaceutical/biotech industry and clear understanding of safety reporting requirements and experience in global regulatory environment and processes. MAJOR RESPONSIBILITIES • Provide medical and safety expertise as the Medical Safety and Pharmacovigilance representative on the product clinical development team., • Lead the preparation and delivery of high quality, consistent and compliant safety information for regulatory submission documents (including IND and NDA)., • Lead/develop strategies for safety-related regulatory activities and support interpretation and authoring of safety sections of documents including Investigators Brochures, clinical trial protocols, informed consent forms, safety management plans, clinical study reports, integrated safety summary and summary of clinical safety., • Manages and conducts ongoing safety surveillance on assigned products. Oversees the preparation of NDA safety updates, IND safety reports, investigator communications, product labeling/package inserts and other periodic safety reports as necessary., • Co-organize, prepare and conduct safety management team meetings for assigned products and responsible for safety surveillance, signal detection and risk management., • Coordinates the new development or maintenance of internal SOPs/WIs to ensure the uniform and timely processing of adverse event reports. Interfaces with internal and external collaborators to develop programs and processes to meet regulatory reporting requirements., • Applies general safety signal management methodologies and product specific signaling strategies to monitor for emerging issues related to assigned products., • Ensure that the safety profiles of assigned HMP products are accurately and consistently represented in relevant labeling documents, identify and lead updates as required., • Perform medical review of individual case safety reports (ICSRs) for assigned products., • Collaborate with cross-functional groups and other regional counterparts to update them on medical assessment, signal detection and safety risk management practices in the US and international markets, • Identify opportunities and manage continuous improvement initiatives as related to medical assessment of pharmacovigilance data., • Assist in the creation, review and implementation of SOPs, Work Instructions, guidelines, documents and other tools pertaining to safety assessment and risk minimization. QUALIFICATIONS • Physician (MD, DO, or equivalent) or PharmD, or PhD in Nursing/Pharmacy with minimum 6-10 years related experience in clinical safety and pharmacovigilance., • Experience in the oncology therapeutic area is preferred., • Demonstrated knowledge of principles of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of drug risks and benefits, and global safety regulations are highly preferred., • Experienced in global regulatory environment and processes (US, UK, EU, AU, JP), and the ability to integrate safety medical knowledge with regulatory and commercial input., • Ability to critically evaluate safety data from multiple sources (clinical trials, animal studies, post-market environment, literature, etc), assess clinical importance, benefit risk and potential strategic impact of the data and present the findings clearly in both written and oral communications., • Experienced in writing/review of aggregate safety documents (DSUR, PSUR, and PBRER etc.) and risk management plans., • Thorough understanding of US and European pharmacovigilance regulations, GCP and ICH guidelines., • Demonstrated knowledge of biostatistics and epidemiology are preferred., • Good ability to interpret complex clinical data and experimental results., • Working knowledge of validated drug safety database (preferably ARGUS) and MedDRA., • Ability to influence, negotiate and communicate with both internal and external stakeholders., • Excellent English (writing and speaking) and excellent mastery of English medical terminology.

Job Description Summary #LI-Remote This is a field-based and remote opportunity supporting a team in an assigned geography in West: California, Oregon, Washington, Idaho, Nevada, Arizona, Utah, Colorado, Montana, Wyoming, North Dakota, South Dakota, Minnesota, Wisconsin. Ability to travel 60-70% over a broad geography is required, with the ability to drive and/or fly within the territory. Must have a valid driver's license. Preferred candidate resides within region, or within a reasonable commuting distance from region border. Novartis is unable to offer relocation support for this role. Please only apply if this location is accessible for you. Company will not sponsor visas for this position. As Regional Director, Medical Science Liaison (MSL) for Cardiovascular and Metabolic (CVM) portfolio, you will set the standard for Field Medical Excellence across the region or local CPO translating strategy into action by driving Field Medical plans, ensuring launch readiness for key products (including MSL deployment, tools, and resources), and strengthening the systems and processes that enable high-impact field execution. You will partner closely with Regional Medical Directors, the Global FME group, and Franchise/Global Medical Affairs teams to deliver results. Job Description Key Responsibilities Lead and guide the Field Medical Team (MSL Managers), ensuring the effective implementation of a Field Medical organization within the assigned region or medical unit Drive the implementation of Field Medical Intelligence and insights, enabling cross-functional exchange, engagement strategy development, and execution Support and ensure Field Medical launch excellence and all related launch activities Build and strengthen regional/CPO Field Medical capabilities, including onboarding, soft skills development, and coaching excellence Plan, coordinate, and deliver MSL and MSL Manager training in collaboration with Global FME and Global Medical Affairs Franchise teams, ensuring local implementation of training curricula and individual development plans Adapt and leverage therapeutic medical resources for external use by MSLs Develop and maintain regional deployment maps across all brands, align on standardized FME/CPO KPIs, ensure tracking, and provide regular reporting of deployment, KPIs, and insights to regional/country and global medical leadership Provide coaching and talent development for direct reports; ensure compliant reporting of technical complaints, adverse events, and special cases within 24 hours, and oversee the distribution of marketing samples where applicable Essential Requirements Education: Graduate degree in science or healthcare required; doctoral degree preferred (MD, PhD, DNP, PharmD, etc.) Minimum of 7 years' experience in a Field Medical-based position within the pharmaceutical industry or as an MSL ispreferred OR8+ years of relevant medical affairs, clinical research, or related experience in a scientific or clinical setting required. Strong clinical knowledge including pharmacotherapy, treatment guidelines, clinical research processes, medical expert engagement strategies, and FDA promotional guidelines, regulations, and ethical guidelines applied to the pharmaceutical industry is required. History of organizational or enterprise impact through strategic thinking, working within a matrix organization and leading others through collaborative teams in a Field Medical-based positionrequired. Candidates will perform their duties in accordance with applicable law, regulations, and Novartis policies. Works within Ethics, Compliance and Promotional policies (Novartis & Federal) and ensures those around them do the same. Works to ensure a diverse and inclusive environment free from all forms of discrimination and harassment. Adherence with Company policies, state and federal laws and regulations Candidate must reside within territory, or within a reasonable daily commuting distance of 50 miles from the territory border. Field based, customer-facing position majority of the time with approximately 60-70% travel required to achieve performance and business objectives (face to face, virtual, email, telephone, etc.). Must have a valid driver's license. Desirable Requirements Previous experience in assigned therapeutic area (CVM) or related therapeutic area is preferred. NOTE: Above level experience criteria are not an exhaustive list. Driving is an Essential Function of this Role: Meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving. COVID-19 Vaccine Policy (customer-facing roles only): While Novartis does not require vaccination for COVID-19 or proof of a recent negative test result for COVID-19 at this time, employees working in customer-facing roles must adhere to and comply with customers' (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to Eh.occupationalhealth@novartis.com. For Field Roles with a Dedicated Training Period: The individual hired for this role will be required to successfully complete certain initial training, including home study, eight (8) or fewer hours per day and forty (40) or fewer hours per week. Novartis Compensation Summary: The salary for this position is expected to range between $225,400 and $418,600 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. To learn more about the culture, rewards and benefits we offer our people _. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $225,400.00 - $418,600.00 Skills Desired Clinical Research, Clinical Study Reports, Customer Engagement, Customer Insights, Disease Management, Health Economics, Internal Medicine, Medical Communication, Medical Information, Microsoft PowerPoint, Microsoft Word, Patient Care, Phase Iv Clinical Trial, Product Placement, Scientific Support, Strategic Direction, Team Player, Teamwork, Utilization Management (Um)

Job Description Summary #LI-Remote This is a field-based and remote opportunity supporting a team in an assigned geography. Ability to travel 60-70% over a broad geography is required, with the ability to drive and/or fly within the territory. Must have a valid driver's license. Preferred candidate resides within region, or within a reasonable commuting distance from region border. Novartis is unable to offer relocation support for this role. Please only apply if this location is accessible for you. Company will not sponsor visas for this position. As Regional Director, Medical Science Liaison (MSL), you will set the standard for Field Medical Excellence across the region or local CPO translating strategy into action by driving Field Medical plans, ensuring launch readiness for key products (including MSL deployment, tools, and resources), and strengthening the systems and processes that enable high-impact field execution. You will partner closely with Regional Medical Directors, the Global FME group, and Franchise/Global Medical Affairs teams to deliver results. Job Description Key Responsibilities Lead and guide the Field Medical Team (MSL Managers), ensuring the effective implementation of a Field Medical organization within the assigned region or medical unit Drive the implementation of Field Medical Intelligence and insights, enabling cross-functional exchange, engagement strategy development, and execution Support and ensure Field Medical launch excellence and all related launch activities Build and strengthen regional/CPO Field Medical capabilities, including onboarding, soft skills development, and coaching excellence Plan, coordinate, and deliver MSL and MSL Manager training in collaboration with Global FME and Global Medical Affairs Franchise teams, ensuring local implementation of training curricula and individual development plans Adapt and leverage therapeutic medical resources for external use by MSLs Develop and maintain regional deployment maps across all brands, align on standardized FME/CPO KPIs, ensure tracking, and provide regular reporting of deployment, KPIs, and insights to regional/country and global medical leadership Provide coaching and talent development for direct reports; ensure compliant reporting of technical complaints, adverse events, and special cases within 24 hours, and oversee the distribution of marketing samples where applicable Essential Requirements Education: Graduate degree in science or healthcare required; doctoral degree preferred (MD, PhD, DNP, PharmD, etc.) Minimum of 7 years' experience in a Field Medical-based position within the pharmaceutical industry or as an MSL ispreferred OR8+ years of relevant medical affairs, clinical research, or related experience in a scientific or clinical setting required. Strong clinical knowledge including pharmacotherapy, treatment guidelines, clinical research processes, medical expert engagement strategies, and FDA promotional guidelines, regulations, and ethical guidelines applied to the pharmaceutical industry is required. History of organizational or enterprise impact through strategic thinking, working within a matrix organization and leading others through collaborative teams in a Field Medical-based positionrequired. Candidates will perform their duties in accordance with applicable law, regulations, and Novartis policies. Works within Ethics, Compliance and Promotional policies (Novartis & Federal) and ensures those around them do the same. Works to ensure a diverse and inclusive environment free from all forms of discrimination and harassment. Adherence with Company policies, state and federal laws and regulations Candidate must reside within territory, or within a reasonable daily commuting distance of 50 miles from the territory border. Field based, customer-facing position majority of the time with approximately 60-70% travel required to achieve performance and business objectives (face to face, virtual, email, telephone, etc.). Must have a valid driver's license. Desirable Requirements Previous experience in assigned therapeutic area (Neuroscience) or related therapeutic area is preferred. NOTE: Above level experience criteria are not an exhaustive list. Driving is an Essential Function of this Role: Meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving. COVID-19 Vaccine Policy (customer-facing roles only): While Novartis does not require vaccination for COVID-19 or proof of a recent negative test result for COVID-19 at this time, employees working in customer-facing roles must adhere to and comply with customers' (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to Eh.occupationalhealth@novartis.com. For Field Roles with a Dedicated Training Period: The individual hired for this role will be required to successfully complete certain initial training, including home study, eight (8) or fewer hours per day and forty (40) or fewer hours per week. Novartis Compensation Summary: The salary for this position is expected to range between $225,400 and $418,600 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. To learn more about the culture, rewards and benefits we offer our people _. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $225,400.00 - $418,600.00 Skills Desired Clinical Research, Clinical Study Reports, Customer Engagement, Customer Insights, Disease Management, Health Economics, Internal Medicine, Medical Communication, Medical Information, Microsoft PowerPoint, Microsoft Word, Patient Care, Phase Iv Clinical Trial, Product Placement, Scientific Support, Strategic Direction, Team Player, Teamwork, Utilization Management (Um)

Job Description Summary LOCATION: Homeworking UK or Ireland or Hybrid Working at Westworks London or Dublin: Please apply only if any of these locations are accessible to you, as relocation support is not available. ROLE TYPE: Homeworking, #LI-Home or Hybrid working, #LI-Hybrid As a core member of the Clinical Trial Team (CTT), the main purpose of this position is accountability for vendor service delivery at the study level to independently manage all clinical vendor related aspects of global clinical trial(s). Job Description Key Responsibilities: Collaborate closely with study team lead and members throughout the study lifecycle. Review vendor-related protocol sections during protocol development. Manage vendor interfaces and support contract negotiations in collaboration with procurement. Oversee vendor cost control, budget reviews, invoice reconciliation, and PO close-out. Ensure vendor service excellence, maintaining quality and service standards at the study level. Drive site activation, compile central documents, and address risks/issues during site activation. Conduct user-acceptance testing (UAT) for eCOA and IRT systems. Monitor vendor-related cycle times and risks using tools like FIRST, while implementing corrective actions as needed. Essential Requirements: • 5+ years of experience with clinical operations and vendor management processes. Strong understanding of GxP and ICH regulations. Solid knowledge of clinical trial design and alignment to supplier requirements. Experience conducting User Acceptance Testing (UAT) for eCOA and IRT systems. Proven expertise in vendor management, including outsourcing, contracting, and sourcing clinical services. Results-oriented, with a track record of completing projects on time. Ability to collaborate effectively in cross-functional teams within a matrixed environment. Strong influencing, negotiation, communication, and problem-solving skills. Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network Skills Desired Budget Management, Clinical Trials, Negotiation Skills, People Management, Process Improvement, Project Planning, Vendor Management, Waterfall Model

Job Description Summary #LI-Onsite Location: The ideal location for this role is East Hanover, New Jersey site but remote work may be possible (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager: US and European travel required (estimated 30-35% annually, up to 40% seasonally). Novartis is unable to offer relocation support: please only apply if accessible. Company will not sponsor visas for this position. Join Novartis at a moment where an inspired, curious, and unbossed medical leader can leave a lasting imprint on cardiovascular and metabolic care-while shaping impact at scale. As Vice President, Medical Team Head for Cardiovascular and Metabolism, you will set the US medical vision for a multibilliondollar portfolio, translating breakthrough science into meaningful patient outcomes. Operating at the intersection of medical innovation, strategy, and external partnership, you will shape standards of care, advance access to innovation, and represent the voice of your therapeutic area at US and Global levels, both internally and externally. This role is built for a bold, collaborative leader energized by complexity, influence, and the opportunity to improve lives. Job Description Key Responsibilities Set and lead the US medical strategy across marketed, prelaunch, and life cycle management indications. Shape the healthcare landscape through strategic partnerships and seniorlevel regulatory engagement, including Food and Drug Administration interactions. Advance patient access by partnering on health outcomes and realworld evidence to support reimbursement and clinical adoption. Expand the portfolio by leading US medical input into business development and licensing and new product commercialization. Drive enterprise impact through crossfunctional leadership across Medical, Clinical Development, Global Medical Affairs, and Commercial teams. Build and develop highperforming teams while modeling an inclusive, inspired, curious, and unbossed Novartis culture. Essential Requirements Bachelor's or equivalent 4-Year University Degree required; Doctoratelevel degree in MD, DO, PharmD, or PhD in Health Sciences or related field required; Medical Degree (MD, DO) or equivalent preferred. Twelve or more years of progressively senior experience in clinical development or medical affairs within the pharmaceutical, biotechnology, or academic institution/clinical practice. More than five years of people management and team leadership experience, with a strong track record of developing senior medical talent is preferred. Deep understanding of the United States healthcare landscape, including payer dynamics, access pathways, and evolving healthcare system trends. Strong clinical research experience, including protocol development, clinical trial operations, and leading patient recruitment strategies. Demonstrated expertise in health economics, outcomes research, and realworld evidence to support patient access, reimbursement, and value demonstration. Demonstrated enterpriselevel influence, with the ability to shape strategy, align senior stakeholders, and drive impact across US and Global organizations. Desirable Requirements Cardiovascular and metabolic therapeutic area experience, with strong diseasestate knowledge and clinical credibility. Established relationships with medical experts and professional societies within the cardiovascular or metabolic landscape. The salary for this position is expected to range between $318,500 and $591,500 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. To learn more about the culture, rewards and benefits we offer our people _. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $318,500.00 - $591,500.00 Skills Desired Apache Continuum, Behavioral Economics, Clinical Practices, Clinical Trials, Collaboration, Cystic Fibrosis, Data Entry, Diversity & Inclusion, Drug Development, Job Description, Leadership, Medical Records, Patient Care, PCB (Printed Circuit Board), People Management, Physical Therapy, Prioritization, Telemetry

Job Description Summary The Medical Science Liaison (MSL) is a field based, customer-facing, non-promotional medical and scientific role. Their key objective is to create impact through advancing clinical practice within the territory that leads to improved patient outcomes. The MSL must demonstrate deep therapeutic expertise, understand territory and market influences, engage scientifically with Healthcare Providers (HCPs) and medical experts, manage, and develop their territory and execute all relevant activities in alignment with the medical strategic and tactical plan - while functioning within the Novartis Code of Conduct, Ethics/Compliance policies and Working Practice documents. The MSL will Inform and shape medical strategy through application of a curious mindset to collect impactful and actionable insights, understanding the strategic impact of critical insights. Job Description Key Responsibilities: The MSL will leverage scientific expertise and market knowledge to establish and build professional relationships and engage with HCPs (including community physicians, pharmacists, medical experts, nurses, and other healthcare professionals) and other thought leaders in geographical area as aligned with medical strategy • The primary responsibility of the MSL is to engage with customers - customer engagements may include but not be limited to emerging data discussions, clinical trial activities, uncovering barriers in patient journey, understanding market dynamics within territory, exploration of areas of unmet medical need, pipeline discussions, educating on disease state and product, capturing adverse events, and capturing medical insights through all stages of product lifecycle., • Must demonstrate strategic territory vision and ensure appropriate territory identification, mapping, and planning of Medical Engagements (MEs) and Key Accounts as aligned to medical strategy and in collaboration with internal Novartis colleagues. This includes: a. identification of key stakeholders with influence in disease space throughout the product development journey to establish strategies for education, engagement, and partnership b. identification of opportunities for partnership with academic centers, centers of excellence, and/or systems of care to drive impact within the assigned territory c. identification of opportunities to involve HCPs or MEs when a specific medical need is identified (e.g., publications, clinical trial participation, etc.) d. identification of opportunities for internal collaboration with other Novartis stakeholders to drive forward therapeutic area, clinical, or product goals as appropriate • Provide clinical trial support for company sponsored trials and facilitating relevant medical activities, including but not limited to identification of appropriate sites, supporting clinical trials (subject recruitment, protocol questions, SIVs, etc.) at sites, and cross-functional collaboration with Medical Affairs and Clinical Operations colleagues, • Regularly collaborate with internal colleagues (e.g., HEOR, access, marketing, commercial) within the assigned therapeutic area and territory to advance clinical practice while maintaining customer centricity and a One Novartis approach in accordance with Novartis compliance standards, • Maintain in-depth knowledge of assigned therapeutic area and Novartis compounds to serve as a medical resource to customers and internal colleagues, • Maintain in-depth knowledge of internal policies and external regulations (e.g., field medical Working Practice Document (WPD), travel policy, expense policy, state and local laws, institutional policies) and how they affect the day-to-day, • Execute all administrative responsibilities and training (e.g., Veeva CRM, voicemail, e-mail, expense reports, compliance modules, etc.) in a timely manner, including profiling of core customers and ensuring up-to-date information in the CRM, • Champion emerging responsibilities as strategic priorities and territory needs evolve, • Proactively drive personal and professional development, • Conduct yourself with the highest ethical standards and adhere to Novartis Code of Conduct. Comply with all relevant laws and regulations and Novartis Ethics, Risk & Compliance policies, and procedures. Essential Requirements: • Education:Graduate degree in science or healthcare required; doctoral degree preferred (MD, PhD, DNP, PharmD, etc.), • Minimum of 3 years' experience in a Field Medical-based position within the pharmaceutical industry or as an MSL is preferred OR5-7 years of relevant medical affairs, clinical research, or related experience in a scientific or clinical setting required., • Strong clinical knowledge including pharmacotherapy, treatment guidelines, clinical research processes, medical expert engagement strategies, and FDA promotional guidelines, regulations, and ethical guidelines applied to the pharmaceutical industry is required., • Candidates will perform their duties in accordance with applicable law, regulations, and Novartis policies., • Works within Ethics, Compliance and Promotional policies (Novartis & Federal) and ensures those around them do the same., • Works to ensure a diverse and inclusive environment free from all forms of discrimination and harassment., • Adherence with Company policies, state and federal laws and regulations, • Candidate must reside within territory, or within a reasonable daily commuting distance of 50 miles from the territory border. Field based, customer-facing position majority of the time with approximately 60-70% travel required to achieve performance and business objectives (face to face, virtual, email, telephone, etc.). Must have a valid driver's license. Desirable Requirements: • Previous experience in assigned or related therapeutic area is preferred. NOTE: Above level experience criteria are not an exhaustive list. Driving is an Essential Function of this Role:Meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving. The salary for this position is expected to range between $160,300.00 and $297,700.00 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. To learn more about the culture, rewards and benefits we offer our people click _. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $160,300.00 - $297,700.00 Skills Desired Building Constructions, Business Analysis, Business Networking, Clinical Protocols, Clinical Research, Clinical Study Reports, Communication, Curious Mindset, Disease Management, Diversity and Inclusion (D&I), Drug Development, Epidemiology, Medical Information, Medical Research, Medical Writing, Microsoft Word, Phase Iv Clinical Trial, Product Placement, Scientific Support

Job Description Summary #LI-Onsite Location: The ideal location for this role is East Hanover, New Jersey site but remote work may be possible (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager: US and European travel required (estimated 30-35% annually, up to 40% seasonally). Novartis is unable to offer relocation support: please only apply if accessible. Company will not sponsor visas for this position. The Vice President, Head of US Medical Immunology, is responsible for developing, implementing, guiding, and communicating Novartis' Clinical Development & Medical Affairs strategy and activities across the evolving therapeutic area franchise. This leader will champion patients' interests as the primary mission, driving both product and enterprise success as a result. In partnership with cross-functional teams, the individual will lead the development of Clinical Development & Medical Affairs strategies spanning evidence-based medicine, scientific operations, publication and communication planning, medical advisory activities, Medical Affairs studies, medical expert engagement, investigator-initiated research, customer-initiated research, and new product launches. In addition, this leader will work closely with the global Clinical Development & Medical Affairs organization to ensure alignment with and execution of global strategies. The individual will continue to build and lead a best-in-class Clinical Development & Medical Affairs team while fostering a culture of excellence, innovation, customer focus, cross-functional collaboration, and teamwork. The Medical Unit Head will also serve as an active member of several internal leadership forums, including the global development FLT, the franchise FLT, and the US Medical Unit leadership team, where this individual will be expected to act as a change agent. Job Description Key Responsibilities Create deep functional bench strength by identifying, attracting, and developing a best-in-class Clinical Development & Medical Affairs team. Ensure effective coaching and training to build technical and leadership skills for maximum performance and long-term succession planning. Cultivate an inclusive, high-performance environment that values and leverages diversity of thinking, style, and experiences. Drive the therapeutic area growth agenda by focusing and aligning resources with key priorities in the region and globally with a focus on the relevant global franchises, with other functions and Corporate/Headquarters groups. Develop cross-functional medical strategy aligned with, and supportive of, commercial strategy. Partner with Commercial to provide strategic medical insights to shape the portfolio strategy. Own key interfaces with the relevant global franchise team. This includes interacting closely and regularly with team members and Franchise Leadership Team members to foster development of the therapeutic areas' business plans, aligning on patient-centric product and services strategies and plans, facilitating best practice sharing and two-way dialog/feedback between local and global stakeholders, providing regional input into the pre-launch and launch activities, informing the US organization about initiatives/outcomes and providing input into allocation of resources and talent development. Partner with Global Development to set strategic direction for Clinical Development & Medical Affairs across development and lifecycle management activities. Provide key strategic input from a US perspective on global clinical development plans. Essential Requirements Bachelor's or equivalent 4-Year University Degree; Doctorate level degree (MD, PharmD, or PhD in Biological Sciences or related field). Twelve or more years of progressively senior experience in clinical development or medical affairs within the pharmaceutical, biotechnology, or academic institution/clinical practice. More than five years of people management and team leadership experience, with a strong track record of managing and developing senior medical talent is preferred. More than 3 years of experience working in immunology/respiratory area in the pharmaceutical industry. Deep understanding of the United States healthcare landscape, including payor dynamics, access pathways, and evolving healthcare system trends. A strong understanding of "good promotional practices" as defined by PhRMA, OIG and ABPI Guidelines, of independent medical education as defined by ACCME. Strong clinical research experience, including protocol development, clinical trial operations, and leading patient recruitment strategies. Demonstrated expertise in health economics, outcomes research, and realworld evidence to support patient access, reimbursement, and value demonstration. Demonstrated enterpriselevel influence, with the ability to shape strategy, align senior stakeholders, and drive impact across US and Global organizations. Desirable Requirements Medical Degree with Board Certification in a relevant specialty Experience presenting at major international medical congresses and engaging global scientific communities The salary for this position is expected to range between $318,500 and $591,500 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. To learn more about the culture, rewards and benefits we offer our people _. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $318,500.00 - $591,500.00 Skills Desired Apache Continuum, Behavioral Economics, Clinical Practices, Clinical Trials, Collaboration, Cystic Fibrosis, Data Entry, Diversity & Inclusion, Drug Development, Job Description, Leadership, Medical Records, Patient Care, PCB (Printed Circuit Board), People Management, Physical Therapy, Prioritization, Telemetry

Job Description Summary -Develops and implements strategic and operational TAs Global Medical Affairs programs, with a focus on innovative evidence and/or launch readiness and/or post-market solutions, including medical affairs planning and execution of the medical/scientific engagement strategy addressing and delivering strategic pre-launch and launch medical activities needs for patient, clinical, access and value to health care systems -Provides expertise in the development and execution of the overarching strategies, providing inputs during design and along the end-to-end execution of programs -Develops and executes the Integrated Evidence Plan (IEP)/functional specific programs to maximize the value proposition for the prioritized launch portfolio and impact of our medicines. Job Description Key Responsibilities: Demonstrate solid competencies as a Medical Leader within the US Medical Affairs organization; preferably with launch experience in the CV space Build positive, effective partnerships with Medical and Commercial as well as US and Global colleagues. Key member of the cross-functional Medical Strategy Team (MST), which drives Medical tactical development and excellence in execution. Drive a robust data generation program to support current indication, as well as pelacarsen's lifecycle. Co-develop strategically aligned study programs with Health Economics & Outcomes Research (HE&OR) colleagues Lead Investigator-Initiated Trial (IIT) program Lead US based Phase 3b/4 studies Collaborate with global team on lifecycle management studies on strategy for USA Foster strong relationships with not only National, but also key Regional and Local Medical Experts, including Investigators. Support Medical Expert Engagement Strategy. Drive advisory boards and work closely with Field Medical on insight-gathering initiatives. Essential Requirements: Education (minimal/desirable): • Bachelors or equivalent 4-Year University Degree required., • Doctorate level degree (MD, PharmD, DO, or PhD in Health Sciences or related field) or Nurse Practitioner (NP)/ Physician's Assistant (PA) degree with significant relevant clinical experience required. Work Experience: Strong Medical Affairs background. Launch experience in CV. Strategy Development. Cross-functional collaboration. The pay range for this position at commencement of employment is between $204,000.00 - $379,600.00 a year.The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. To learn more about the culture, rewards and benefits we offer our people click _. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $204,400.00 - $379,600.00 Skills Desired Agility, Agility, Clinical Practices, Cross-Functional Collaboration, Data Analysis, Drug Development, Employee Development, Healthcare Sector Understanding, Health Sciences, Influencing Skills, Innovation, Inspirational Leadership, Integrated Evidence Generation, Medical Affairs, Medical Communication, Medical Education, Patient Care, People Management, Pharmaceutics, Priority Disease Areas Expertise, Product Launches, Product Strategy, Real World Evidence (RWE), Regulatory Compliance, Research Methodologies {+ 4 more}

Job Description Summary Location: Westworks, London, UK Full time, Hybrid, #LI-Hybrid As the study's start-up linchpin subject matter expert for eCOA and Translations, the Vendor Start-Up Manager ensures vendors are fully aligned, validated, and ready to deliver-protecting timelines, quality, and patient experience from protocol finalisation through database go-live. Job Description Reporting to the Vendor Alliance Lead, the Vendor Startup Manager (VSM) eCOA & Translations is responsible to provide technical expertise for a given category during study startup to the TVM Trial Vendor Manager and indirectly to the study start-up team. The VSM enables a flawless and accelerated vendor service delivery at the trial start-up phase and supports implementation of defined category strategies and service standardization. The VSM proactively assesses risk and concludes contingency plans to de-risk study startup. They will also lead initiatives for continuous improvement and optimisation of the Study Start-Up process and will support practice leaders in improvement projects and learning loops. Key accountabilities and responsibilities • Reviewing of the vendor and category related specific sections of the protocol, ensure vendor expertise is leveraged when refining specifications aligning to Final Protocol • Contributing to development of Study Specification Worksheet (SSW) to facilitate bid process and selection of Vendors.Actively contribute to Quote/Proposal reviews, support Contract negotiations and review of final quotes. • Co-ordinates vendor kick-off meeting and other vendor specific meetings, • Collects HA submission documents from vendor, as requested by countries participating ina study, • Performs robust User Acceptance Testing (UAT) for eCOA, • Ensures changes to protocol or study designs are consistently shared with vendors andincorporated into supplier budgets, timelines, and specifications. Supports protocol amendments and revisedvendor contracts alongside Procurement team, • Looks for opportunities to optimise and improve frontloaded and timely study start-up process in support of a timely vendorDB-go-live, • Promotes Vendor service excellence at study level, ensures vendors meet quality and service levelstandards in their service delivery for the trial. Use of relevant tools such as Unified Vendor Portal to manage service delivery., • Pro-actively creates and maintains vendor related risk maps with contingency plan for documentation in FIRST tool • Document issues identified with vendor oversight / performance in FIRST tool and implements and monitors corrective actions. Escalates issue if required to the VAL Vendor Alliance Lead and drives root cause analysis of supplier performance issues and looks for trends • Supports the implementation of standards, templates, tools, and processes for vendors atSSU for defined categories in collaboration with the VAL What you will bring to the role: Advanced degree in science or business with equivalent experience Strong demonstrated experience in the eCOA industry (ideally a period of 5-7+ years working in eCOA) and excellent knowledge of the clinical operation processes and vendor management Excellent knowledge of GxP and ICH regulations Expert knowledge of clinical trial design and mapping to supplier requirements Demonstrated leadership with supplier relationship management and/or expert knowledge of specific service areas Strong collaborative mindset and capability to liaise closely with key internal and external stakeholders Demonstrated root cause analysis, problem solving, and solution generation skills Experience in User Acceptance testing (eCOA ) Knowledge of key deliverables that impact green light milestones and vendor readiness Experience in outsourcing, contracting, sourcing of clinical services with Vendor/CROs (RFP, RFQ, contracting) Specific category expertise - specifically eCOA/ePRO Skills Desired Analysis, Innovation, Lifesciences, Operational Excellence, Scientific Support, Waterfall Model

Job Description Summary Onsite #LI-Onsite East Hanover, New Jersey About the role: The Statistical Programming community at Novartis comprises of approximately 350 (internal) statistical programmers and belongs to the Advanced Quantitative Sciences (AQS) organization which also includes more than 450 biostatisticians, pharmacometricians and data scientists supporting the entire portfolio of clinical projects across the Research, Development and Commercial spectrum. In this role, you will be responsible for all statistical programming (SP) aspects of several studies, a medium to large sized program or program-level activities (incl. submission and post- marketing activities). You will be a key collaborator and strategic partner with cross-functional team members within the clinical trial/program, ensuring the integrated/ clinical development/ evidence plans are executed efficiently with timely and high-quality deliverables Job Description Your Key Responsibilities: Lead statistical programming activities as a trial programmer for one or multiple trial(s) or as a lead/ program programmer for a program or an indication. May coordinate activities of internal/ external programmers. Make SP decisions and propose strategies at study, program or indication/ disease level. May act as functional manager of associates including providing supervision and guidance to these programmers on operational / functional expertise and processes. Build and maintain effective working relationship with cross-functional teams, able to summarize and discuss status of deliverables and critical programming aspects (timelines, scope, resource plan), e.g. as statistical programming representative in study- or program-level team. Review eCRF, data structures, and ensure program-level standardization for effective pooling and efficient case record tabulation (CRT) production. Comply with company, department and industry standards (e.g. CDISC) and processes, assess and clarify additional programming requirements, review, develop and influence programming specifications as part of the analysis plans (incl. program-level strategies). Provide and implement statistical programming solutions; ensure knowledge sharing. Act as programming expert in problem-solving aspects. Ensure timely and quality development and validation of datasets and outputs for clinical study reports (CSRs), regulatory submissions/interactions, safety reports, publications, post-marketing activities or exploratory analyses (as required) in the assigned drug development studies/program. Responsible for quality control and inspection readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results. Maintain up-to-date advanced knowledge of programming software (e.g. SAS, R) as well as industry requirements (e.g. CDISC, eCTD, Define.xml). May act as subject matter expert (SME) on process improvement/non-clinical initiatives with a focus on programming. Video Link _ This position will be located at the East Hanover, New Jersey site and will not have the ability to be located remotely. Role Requirements: Essential Requirements: BS degree in statistics, computer science, mathematics, life science or equivalent relevant degree and 7+ years of work experience in a programming role preferably supporting clinical trials/ or in pharmaceutical industry Experience as Trial/Lead/Program Programmer for several studies or project-level activities, including coordination of team of internal or external programmers on a given study/program, ability to transfer own knowledge to others Expert SAS/R experience and proven skills in the use of SAS/R within a Statistical Programming environment to develop and validate deliverables, proven experience in development of advanced MACROs Advanced experience in contributing to statistical analysis plans and/or constructing technical programming specifications Advanced knowledge of industry standards including CDISC data structures as well as a solid understanding of the development and use of standard programs Good understanding of regulatory requirements relevant to Statistical Programming (e.g. GCP, study procedures) Proven communications and negotiation skills, ability to work well with others globally and influence Desired Requirements: MS or Ph.D degree in statistics, computer science, mathematics, life science, or equivalent Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $119,700 and $222,300 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. To learn more about the culture, rewards and benefits we offer our people click _. Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: _ You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. _ Accessibility and Reasonable Accommodations: The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: _ EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $119,700.00 - $222,300.00 Skills Desired Classification Systems, Clinical Trials, Computer Data Storage, Computer Programming, Cross-Functional Teams, Data Analysis, Data Structures, Initiative, Programming Languages, Reporting, Statistical Analysis

Job Description Summary #LI-Remote The Medical Science Liaison (MSL) role is a field based, customer-facing, non-promotional medical and scientific position. The MSL's key objective is to create impact through advancing clinical practice within the assigned territory that leads to improved patient outcomes. The MSL must demonstrate deep therapeutic expertise, understand territory and market influences, engage scientifically with Healthcare Providers (HCPs) and medical experts, manage, and develop their territory and execute all relevant activities in alignment with the medical strategic and tactical plan - while functioning within the Novartis Code of Conduct, Ethics/Compliance policies and Working Practice documents. The MSL will Inform and shape medical strategy through application of a curious mindset to collect impactful and actionable insights, understanding the potential strategic impact of critical insights. This is a field-based and remote opportunity supporting key accounts in an assigned geography: South Texas. The preferable location for the successful candidate would be to reside in San Antonio or Austin, Texas or near a major airport in territory. Novartis is unable to offer relocation support for this role. Please only apply if this location is accessible for you. Company will not sponsor visas for this position. Job Description Key responsibilities: The MSL will leverage scientific expertise and market knowledge to establish and build professional relationships and engage with HCPs (including community physicians, pharmacists, medical experts, nurses, and other healthcare professionals) and other thought leaders in geographical area as aligned with medical strategy. The primary responsibility of the MSL is to engage with customers - customer engagements may include but are not limited to: emerging data discussions, clinical trial activities, uncovering barriers in patient journey, understanding market dynamics within their territory, exploration of areas of unmet medical need, pipeline discussions, educating on disease state and product, capturing adverse events, and capturing medical insights through all stages of product lifecycle. Must demonstrate strategic territory vision and ensure appropriate territory identification, mapping, and planning of Medical Engagements (MEs) and Key Accounts as aligned to medical strategy and in collaboration with internal Novartis colleagues. This includes: a. identification of key stakeholders with influence on the patient journey and in the disease space throughout the product development lifecycle to establish strategies for education, engagement, and partnership b. identification of opportunities for partnership with academic centers, centers of excellence, and/or systems of care to drive impact within the assigned territory c. identification of opportunities to involve HCPs or MEs when a specific medical need is identified (e.g., publications, clinical trial participation, etc.) d. identification of opportunities for internal collaboration with other Novartis stakeholders to drive forward therapeutic area, clinical, or product goals as appropriate Provide clinical trial support for company sponsored trials facilitating relevant medical activities and working cross-functionally with Medical Affairs and Clinical Operations colleagues. Regularly and effectively collaborates with internal colleagues (e.g., HEOR, access, marketing, commercial, sales) within the assigned therapeutic area and territory to advance clinical practice while maintaining customer centricity and a One Novartis approach in accordance with Novartis compliance standards. Maintain in-depth knowledge of assigned therapeutic area and Novartis compounds to serve as a medical resource to customers and internal colleagues (in accordance with Working Practice Documents). Maintain in-depth knowledge of internal policies and external regulations (e.g., field medical Working Practice Document (WPD), travel policy, expense policy, state and local laws, institutional policies) and how they affect day-to-day responsibilities. Execute all administrative responsibilities and training (e.g., Veeva CRM, voicemail, e-mail, expense reports, compliance modules, etc.) in a timely manner, including profiling of core customers and ensuring up-to-date information in the CRM. Champion emerging responsibilities as strategic priorities and territory needs evolve. Proactively drive personal and professional development. Essential Requirements: Education: Graduate degree in science or healthcare required; doctoral degree preferred (MD, PhD, DNP, PharmD, etc.) Leveling Guidelines: the position will be filled at level commensurate with experience. Experience for Manager Level: 0-3 years of experience in a Field Medical position within the pharmaceutical industry or as an MSL is required OR3-5 years of relevant medical affairs, clinical research, or related experience in a scientific or clinical setting preferred. Experience for Associate Director Level: Minimum of 3 years' experience in a Field Medical-based position within the pharmaceutical industry or as an MSL is preferred OR5-7 years of relevant medical affairs, clinical research, or related experience in a scientific or clinical setting required. Experience all levels: Strong clinical knowledge including pharmacotherapy, treatment guidelines, clinical research processes, medical expert engagement strategies, and FDA promotional guidelines, regulations, and ethical guidelines applied to the pharmaceutical industry is required. Candidates will perform their duties in accordance with applicable law, regulations, and Novartis policies. Works within Ethics, Compliance and Promotional policies (Novartis & Federal) and ensures those around them do the same. Works to ensure a diverse and inclusive environment free from all forms of discrimination and harassment. Adherence with Company policies, state and federal laws and regulations Candidate must reside within territory, or within a reasonable daily commuting distance of 50 miles from the territory border. Field based, customer-facing position majority of the time with approximately 60-70% travel required to achieve performance and business objectives (face to face, virtual, email, telephone, etc.). Must have a valid driver's license. Desirable Requirements: Previous experience in assigned or related therapeutic area is preferred. NOTE: Above level experience criteria are not an exhaustive list. Driving is an Essential Function of this Role: Meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving. COVID-19 Vaccine Policy (customer-facing roles only): While Novartis does not require vaccination for COVID-19 or proof of a recent negative test result for COVID-19 at this time, employees working in customer-facing roles must adhere to and comply with customers' (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to Eh.occupationalhealth@novartis.com. For Field Roles with a Dedicated Training Period: The individual hired for this role will be required to successfully complete certain initial training, including home study, eight (8) or fewer hours per day and forty (40) or fewer hours per week. Novartis Compensation Summary: The pay range for this position at commencement of employment is expected to be between; for Manager: $145,600 - $270,400 year and for Associate Director: $160,300 - $297,700 year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. To learn more about the culture, rewards and benefits we offer our people click _. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $160,300.00 - $297,700.00 Skills Desired Biostatistics, Clinical Practices, Clinical Research, Clinical Study Reports, Curious Mindset, Customer Relationship Management (CRM) Software, Disease Management, Drug Development, Education, Epidemiology, IT Tools, Medical Information, Medical Research, Medical Writing, Phase Iv Clinical Trial, Product Placement, Scientific Support

Job Description Summary The Medical Science Liaison (MSL) is a field based, customer-facing, non-promotional medical and scientific role. Their key objective is to create impact through advancing clinical practice within the territory that leads to improved patient outcomes. The MSL must demonstrate deep therapeutic expertise, understand territory and market influences, engage scientifically with Healthcare Providers (HCPs) and medical experts, manage, and develop their territory and execute all relevant activities in alignment with the medical strategic and tactical plan - while functioning within the Novartis Code of Conduct, Ethics/Compliance policies and Working Practice documents. The MSL will Inform and shape medical strategy through application of a curious mindset to collect impactful and actionable insights, understanding the strategic impact of critical insights. Job Description Key Responsibilities: The MSL will leverage scientific expertise and market knowledge to establish and build professional relationships and engage with HCPs (including community physicians, pharmacists, medical experts, nurses, and other healthcare professionals) and other thought leaders in geographical area as aligned with medical strategy • The primary responsibility of the MSL is to engage with customers - customer engagements may include but not be limited to emerging data discussions, clinical trial activities, uncovering barriers in patient journey, understanding market dynamics within territory, exploration of areas of unmet medical need, pipeline discussions, educating on disease state and product, capturing adverse events, and capturing medical insights through all stages of product lifecycle., • Must demonstrate strategic territory vision and ensure appropriate territory identification, mapping, and planning of Medical Engagements (MEs) and Key Accounts as aligned to medical strategy and in collaboration with internal Novartis colleagues. This includes: a. identification of key stakeholders with influence in disease space throughout the product development journey to establish strategies for education, engagement, and partnership b. identification of opportunities for partnership with academic centers, centers of excellence, and/or systems of care to drive impact within the assigned territory c. identification of opportunities to involve HCPs or MEs when a specific medical need is identified (e.g., publications, clinical trial participation, etc.) d. identification of opportunities for internal collaboration with other Novartis stakeholders to drive forward therapeutic area, clinical, or product goals as appropriate • Provide clinical trial support for company sponsored trials and facilitating relevant medical activities, including but not limited to identification of appropriate sites, supporting clinical trials (subject recruitment, protocol questions, SIVs, etc.) at sites, and cross-functional collaboration with Medical Affairs and Clinical Operations colleagues, • Regularly collaborate with internal colleagues (e.g., HEOR, access, marketing, commercial) within the assigned therapeutic area and territory to advance clinical practice while maintaining customer centricity and a One Novartis approach in accordance with Novartis compliance standards, • Maintain in-depth knowledge of assigned therapeutic area and Novartis compounds to serve as a medical resource to customers and internal colleagues, • Maintain in-depth knowledge of internal policies and external regulations (e.g., field medical Working Practice Document (WPD), travel policy, expense policy, state and local laws, institutional policies) and how they affect the day-to-day, • Execute all administrative responsibilities and training (e.g., Veeva CRM, voicemail, e-mail, expense reports, compliance modules, etc.) in a timely manner, including profiling of core customers and ensuring up-to-date information in the CRM, • Champion emerging responsibilities as strategic priorities and territory needs evolve, • Proactively drive personal and professional development, • Conduct yourself with the highest ethical standards and adhere to Novartis Code of Conduct. Comply with all relevant laws and regulations and Novartis Ethics, Risk & Compliance policies, and procedures. Essential Requirements: • Education:Graduate degree in science or healthcare required; doctoral degree preferred (MD, PhD, DNP, PharmD, etc.), • Minimum of 3 years' experience in a Field Medical-based position within the pharmaceutical industry or as an MSL is preferred OR5-7 years of relevant medical affairs, clinical research, or related experience in a scientific or clinical setting required., • Strong clinical knowledge including pharmacotherapy, treatment guidelines, clinical research processes, medical expert engagement strategies, and FDA promotional guidelines, regulations, and ethical guidelines applied to the pharmaceutical industry is required., • Candidates will perform their duties in accordance with applicable law, regulations, and Novartis policies., • Works within Ethics, Compliance and Promotional policies (Novartis & Federal) and ensures those around them do the same., • Works to ensure a diverse and inclusive environment free from all forms of discrimination and harassment., • Adherence with Company policies, state and federal laws and regulations, • Candidate must reside within territory, or within a reasonable daily commuting distance of 50 miles from the territory border. Field based, customer-facing position majority of the time with approximately 60-70% travel required to achieve performance and business objectives (face to face, virtual, email, telephone, etc.). Must have a valid driver's license. Desirable Requirements: • Previous experience in assigned or related therapeutic area is preferred. The salary for this position is expected to range between $160,300.00 and $297,700.00 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. To learn more about the culture, rewards and benefits we offer our people click _. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $160,300.00 - $297,700.00 Skills Desired Building Construction, Business Analysis, Business Networking, Clinical Practices, Clinical Research, Clinical Study Reports, Collaboration, Curious Mindset, Disease Management, Diversity & Inclusion, Drug Development, Epidemiology, Medical Information, Medical Research, Medical Writing, Microsoft Word, Phase Iv Clinical Trial, Product Placement, Scientific Support

Job Description Summary Location: Cambridge, MA. Hybrid May consider DWA, but candidates local to onsite preferred #LI-Hybrid Experience will determine which level 6 (Senior CPL or CPL) is appropriate after interview process based on skills and experience. CPL: Provides strategic medical guidance and leads the development of experimental oncology agents in the TCO portfolio, beginning with PE / DC (Portfolio Entry / Drug Candidate) of preclinical development and continuing through TDP (Transition Decision Point). Job Description Major Accountabilities Provides strategic medical and scientific leadership and expertise to all line functions on the project team for the development of new oncology agents (e.g., small molecules, biologics, radioligand therapies) that are in preclinical development, typically beginning at the PE / DC Creates clinical development strategies for new oncology agents within the PE/ DC to TDP timeframe. The development strategy combines the CPL's medical knowledge with the expertise of colleagues in a wide range of other disciplines (e.g., Clinical Pharmacology, Biostatistics) to optimize the clinical development strategy. Delivers solutions within functions, across functions, and on global projects, developing independent approach to TCO strategy. Although registration studies are not within the responsibility of TCO, the CPL must provide an early clinical development strategy that foresees and supports subsequent registration trials. Development of the Integrated Development Plan Approval (IDPA) in alignment with CPL Disease Area Leads (DALs), Development (DEV), Strategy & Growth (S&G), and Commercial teams Lead Biomedical Research Early Program Teams (BPTs) to enable the start of clinical development and continuing through clinical trials needed to support TDP. May lead multiple global project teams Integrates preclinical information (pharmacology, toxicology, and pharmacokinetics) and interprets implications for clinical development, as articulated in the Investigator's Brochure and First-in-Human protocol Collaborates with clinical scientists to develop clinical protocols for TCO compounds and develop the instruments needed to implement, interpret and report them (e.g., case report forms, report and analysis plans, clinical study reports) Applies own medical knowledge to guide the safe, ethical and efficient conduct of the trials under own responsibility. Knowledgeable in Good Clinical Practice guidelines and Novartis Standard Operating Procedures and strives to maintain compliance with them Liaises with outside experts, investigators, and regulatory authorities in oncology, and represents own projects to those groups and authorities Writes and reviews abstracts/manuscripts etc. for presentation/publications at internal/external meetings Participates in task forces to support continuous improvement and other management objectives. Operational responsibility for quality and compliance May provide informal mentorship to less experienced CPLs Qualifications: Education: MD or DO degree Board-certification in an oncology specialty and PhD-level science are preferred Languages: Fluent English - Oral and written Experience/Professional requirement: At least 2 years of pharmaceutical/biotech industry experience in oncology clinical trials plus the equivalent duration experience from an academic medical center. If limited or no Pharmaceutical industry experience, then comparable senior academic experience in translational oncology and clinical research Experience within RLT preferred Recognized as an expert in your field by external medical experts. External candidates have a substantial record of publication and international recognition Excellent interpretation of oncology preclinical data (molecular biology, pharmacology, pharmacokinetics, and toxicology) Strong knowledge of the application of PK/PD and biostatistics to clinical development and clinical trials Proven ability to analyze and interpret efficacy and safety data relating to oncology Knowledge of GCP and world-wide regulatory requirements for clinical trials and oncology Excellent medical/scientific writing skills Successful track record of strategic thinking Proven ability to develop and inspire project/line/matrix multidisciplinary teams in a global environment Excellent personal ethical integrity and a commitment to improving the outcomes for patients with malignancies Excellent written and oral English communication/presentation skills Strong office IT skills Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $248,500.00 - 461,500.00 USD Annual per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $248,500.00 - $461,500.00 Skills Desired Clinical Monitoring, Clinical Research, Clinical Trial Protocol, Clinical Trials, Decision Making Skills, Drug Development, Health Sciences, Medical Strategy, Regulatory Compliance

Job Description Summary Onsite #LI-Onsite East Hanover, New Jersey About the role: The Statistical Programming community at Novartis comprises of approximately 350 (internal) statistical programmers and part of the Advanced Quantitative Sciences (AQS) organization which also includes more than 450 biostatisticians, pharmacometricians and data scientists supporting the entire portfolio of clinical projects across the Research, Development and Commercial spectrum In this role, you will be responsible for all statistical programming aspects of one or more drug development programs or indication programs. This role may involve being a people manager, a program lead, or both. You will lead cross-functional collaboration within and outside AQS and decision-making for assigned trials/programs in drug life cycle management and efficient, timely execution of integrated/clinical development/evidence plans. You will also take on strategic technical roles across programs or at an enterprise level. This includes, but is not limited to, consulting on pooling strategies, acting as a subject matter expert (SME) at audits/inspections, and leading technical non-clinical initiatives. You will engage with and influence industry working groups and organizations. Job Description Your Key Responsibilities: Lead statistical programming activities for multiple clinical trials within a program or an indication /disease area, or development program. Accountable for timely and quality development and validation of all statistical programming components on assigned program(s). Responsible for audit readiness of all assigned statistical programming deliverables as well as accuracy and reliability of statistical analysis results. Coordinate activities of internal / external programmers. Make statistical programming decisions and propose strategies at program or indication/disease level. Develop scientific documentation for the program(s) or indication/disease area together with the Biostatistician(s). Responsible for allocating resources within a program and ensuring resource sharing between programs to meet AQS and organizational goals. May act as an operational and/or functional manager of associates including providing supervision and guidance to these programmers on operational / functional expertise and processes. Recruit, mentor, and develop statistical programmers. Build and maintain effective working relationships with cross-functional team members within the clinical trial/program, and able to summarize and discuss status of deliverables and critical programming aspects with them (timelines, scope, resource plan). Maintain up-to-date advanced knowledge of programming software (e.g. SAS/R) as well as industry requirements (e.g. CDISC, eCTD, Define.xml), attend functional meetings and training. Represent statistical programming at indication or program-level, in audits/inspections and Health Authority (HA) meetings, and on technical programming aspects in external conferences or consortiums (e.g. CDISC). Offer expert technical and professional recommendations, thought leadership for the SP function at the indication/ program level or for non-clinical initiatives. Video Link _ This position will be located at the East Hanover, New Jersey site and will not have the ability to be located remotely. Role Requirements: Essential Requirements: BS/MS degree in life science, computer science, statistics, mathematics, or equivalent relevant degree and 6+ years in a programming or statistical role. 3+ years experience in a line management or equivalent leadership experience, such as matrix management (applicable for people managers only). Demonstrated leadership, collaboration, and organizational skills with the ability to successfully manage and oversee multiple trials simultaneously, ensuring deadlines are met. In-depth understanding of clinical trials methodology, regulatory requirements, and Good Clinical Practice (GCP) Expert in SAS or R programming, including the development and validation of deliverables within a Statistical Programming environment, and the creation of advanced MACROs and/or functions. Significant experience in contributing to statistical analysis plans and developing technical programming specifications. Advanced knowledge of industry standards, including CDISC standards, and a solid understanding of the development and use of standard programs. At least 2+ years of experience as a Lead/Program/Project Programmer for one or more programs/indications, including the coordination of large teams of internal and/or external programmers. Excellent interpersonal skills with a proven ability to operate effectively in a global environment, influencing and communicating across functions and with external stakeholders. Desired Requirements: 10+ years experience in a programming or statistical role equivalent Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $145,600 and $270,400 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. To learn more about the culture, rewards and benefits we offer our people click _. Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: _ You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. _ Accessibility and Reasonable Accommodations: The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: _ EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $145,600.00 - $270,400.00 Skills Desired Classification Systems, Clinical Trials, Computer Data Storage, Computer Programming, Cross-Functional Teams, Data Analysis, Data Structures, Initiative, People Management, Programming Languages, Reporting, Statistical Analysis, Waterfall Model

Job Description Summary LOCATION: Homeworking UK or Ireland or Hybrid Working at Westworks London or Dublin: Please apply only if any of these locations are accessible to you, as relocation support is not available. ROLE TYPE: Homeworking, #LI-Home or Hybrid working, #LI-Hybrid When we put our heads together, we can do brilliant work. And when we do brilliant work, we can achieve remarkable things for patients as we positively transform healthcare. We are currently looking for a Trial Vendor Senior Manager to join our team. The main purpose of this position is to be accountable for all vendor related operational trial deliverables, according to timelines, budget, operational procedures, quality/compliance and performance standards. To collaborate with the Vendor Start-up Manager (VSM) for the VSM's category specific responsibilities and be responsible for all activities for which no VSM is assigned with, and for all of the service deliveries after Study Start-up when the VSM is no longer assigned to the study. Job Description As a Core member of the Clinical Trial Team (CTT) you will independently managing all vendor-related aspects of global clinical trial(s) to deliver study outcomes within schedule, budget, quality/compliance and performance standards, you will be accountable for vendor service delivery at study level and collaborate closely with the VSM for selected services (central labs, electronic clinical outcomes assessment/electronic patient reported outcomes (eCOA/ePRO), interactive response technology (IRT), cardiac and respiratory diagnostics, patient recruitment and retention (PR&R), and imaging reading) during study start-up and leverage your technical and study start-up (SSU) expertise to ensure a timely study start-up. You will proactively manage vendor-related risks and potential issues and implement global vendor strategy. Key Responsibilities: Collaborate closely with the study team lead and members throughout the study lifecycle. Review vendor-related protocol sections during protocol development. Drive or support the development and completion of Study Specification Worksheet (SSW) to facilitate vendor bid processes. Manage vendor interfaces in cooperation with partner functions, including quote reviews and contract negotiations. Oversee vendor cost control, budget reviews, invoice reconciliation, and purchase order (PO) close-out. Ensure vendor service excellence at the study level, meeting quality and service standards. Optimize study start-up processes and manage central vendor-related activities (e.g., site activation, supply tracking). Monitor vendor risk and performance using tools such as FIRST, Unified Vendor Portal (UVP), and Clinical Insights, implementing corrective actions as needed. Essential Requirements: Bachelor's degree or equivalent; advanced degree preferred. Fluency in English (oral and written). Minimum of 3 years' experience in clinical operations and vendor management processes. Strong knowledge of Good Practice (GxP) and International Council for Harmonization (ICH) regulations, clinical trial design, and supplier service specifications. Proficiency in vendor management, contracting, and site-related collaborations, including Information Technology Service Management (UAT) for eCOA and IRT systems. Results-driven with proven ability to complete projects within timelines. Excellent interpersonal, negotiation, problem-solving, and communication skills in a matrixed environment. Demonstrated networking abilities, team collaboration, and decision-making capabilities. Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network Skills Desired Budget Management, Clinical Trials, Negotiation Skills, Process Improvement, Project Planning, Vendor Management, Waterfall Model

Job Description Summary The Medical Science Liaison (MSL) is a field based, customer-facing, non-promotional medical and scientific role. Their key objective is to create impact through advancing clinical practice within the territory that leads to improved patient outcomes. The MSL must demonstrate deep therapeutic expertise, understand territory and market influences, engage scientifically with Healthcare Providers (HCPs) and medical experts, manage, and develop their territory and execute all relevant activities in alignment with the medical strategic and tactical plan - while functioning within the Novartis Code of Conduct, Ethics/Compliance policies and Working Practice documents. The MSL will Inform and shape medical strategy through application of a curious mindset to collect impactful and actionable insights, understanding the strategic impact of critical insights. Job Description Key Responsibilities: The MSL will leverage scientific expertise and market knowledge to establish and build professional relationships and engage with HCPs (including community physicians, pharmacists, medical experts, nurses, and other healthcare professionals) and other thought leaders in geographical area as aligned with medical strategy • The primary responsibility of the MSL is to engage with customers - customer engagements may include but not be limited to emerging data discussions, clinical trial activities, uncovering barriers in patient journey, understanding market dynamics within territory, exploration of areas of unmet medical need, pipeline discussions, educating on disease state and product, capturing adverse events, and capturing medical insights through all stages of product lifecycle., • Must demonstrate strategic territory vision and ensure appropriate territory identification, mapping, and planning of Medical Engagements (MEs) and Key Accounts as aligned to medical strategy and in collaboration with internal Novartis colleagues. This includes: a. identification of key stakeholders with influence in disease space throughout the product development journey to establish strategies for education, engagement, and partnership b. identification of opportunities for partnership with academic centers, centers of excellence, and/or systems of care to drive impact within the assigned territory c. identification of opportunities to involve HCPs or MEs when a specific medical need is identified (e.g., publications, clinical trial participation, etc.) d. identification of opportunities for internal collaboration with other Novartis stakeholders to drive forward therapeutic area, clinical, or product goals as appropriate • Provide clinical trial support for company sponsored trials and facilitating relevant medical activities, including but not limited to identification of appropriate sites, supporting clinical trials (subject recruitment, protocol questions, SIVs, etc.) at sites, and cross-functional collaboration with Medical Affairs and Clinical Operations colleagues, • Regularly collaborate with internal colleagues (e.g., HEOR, access, marketing, commercial) within the assigned therapeutic area and territory to advance clinical practice while maintaining customer centricity and a One Novartis approach in accordance with Novartis compliance standards, • Maintain in-depth knowledge of assigned therapeutic area and Novartis compounds to serve as a medical resource to customers and internal colleagues, • Maintain in-depth knowledge of internal policies and external regulations (e.g., field medical Working Practice Document (WPD), travel policy, expense policy, state and local laws, institutional policies) and how they affect the day-to-day, • Execute all administrative responsibilities and training (e.g., Veeva CRM, voicemail, e-mail, expense reports, compliance modules, etc.) in a timely manner, including profiling of core customers and ensuring up-to-date information in the CRM, • Champion emerging responsibilities as strategic priorities and territory needs evolve, • Proactively drive personal and professional development, • Conduct yourself with the highest ethical standards and adhere to Novartis Code of Conduct. Comply with all relevant laws and regulations and Novartis Ethics, Risk & Compliance policies, and procedures. Essential Requirements: • Education:Graduate degree in science or healthcare required; doctoral degree preferred (MD, PhD, DNP, PharmD, etc.), • Minimum of 3 years' experience in a Field Medical-based position within the pharmaceutical industry or as an MSL is preferred OR5-7 years of relevant medical affairs, clinical research, or related experience in a scientific or clinical setting required., • Strong clinical knowledge including pharmacotherapy, treatment guidelines, clinical research processes, medical expert engagement strategies, and FDA promotional guidelines, regulations, and ethical guidelines applied to the pharmaceutical industry is required., • Candidates will perform their duties in accordance with applicable law, regulations, and Novartis policies., • Works within Ethics, Compliance and Promotional policies (Novartis & Federal) and ensures those around them do the same., • Works to ensure a diverse and inclusive environment free from all forms of discrimination and harassment., • Adherence with Company policies, state and federal laws and regulations, • Candidate must reside within territory, or within a reasonable daily commuting distance of 50 miles from the territory border. Field based, customer-facing position majority of the time with approximately 60-70% travel required to achieve performance and business objectives (face to face, virtual, email, telephone, etc.). Must have a valid driver's license. Desirable Requirements: • Previous experience in assigned or related therapeutic area is preferred. NOTE: Above level experience criteria are not an exhaustive list. Driving is an Essential Function of this Role:Meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving. The salary for this position is expected to range between $160,300.00 and $297,700.00 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. To learn more about the culture, rewards and benefits we offer our people click _. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $160,300.00 - $297,700.00 Skills Desired Building Constructions, Business Analysis, Business Networking, Clinical Protocols, Clinical Research, Clinical Study Reports, Communication, Curious Mindset, Disease Management, Diversity and Inclusion (D&I), Drug Development, Epidemiology, Medical Information, Medical Research, Medical Writing, Microsoft Word, Phase Iv Clinical Trial, Product Placement, Scientific Support

Job Description Summary #LI-Hybrid Hybrid Working: This role requires a hybrid working model based in East Hanover, New Jersey, with an expectation of 12 days per month onsite. Novartis cannot sponsor visas for this location. Location: East Hanover, United States Relocation Support: This role is based in East Hanover, United States. Novartis is unable to offer relocation support: please only apply if accessible. Imagine shaping the data that brings life-changing medicines to patients faster. As a Principal Clinical Data Scientist at Novartis, you will play a critical role in ensuring the integrity, quality, and timeliness of clinical trial data across entire programs or assigned trials. You will lead end-to-end data management activities, overseeing study delivery, driving key performance indicators, and ensuring inspection-ready data that supports timely submissions to health authorities. By introducing innovative, data-driven solutions, you will enable efficient and high-quality drug development. Working at the heart of cross-functional clinical trial teams, you will collaborate closely with data quality experts, clinical teams, and external partners, fostering a high-performing, well-organized team environment. Your work will directly influence clinical decision-making and ultimately help improve outcomes for patients worldwide. Job Description Key Responsibilities Lead end-to-end data management for multiple clinical trials or across programs from Phase I to IV. Drive study and/or program-level data strategies aligned with therapeutic area and organizational objectives. Coordinate internal and external data scientists to ensure high-quality, timely study delivery. Provide expert input to protocol design, ensuring data quality, feasibility, and efficient data collection. Identify and resolve data-related risks impacting database design, analysis, or reporting outcomes. Collaborate cross-functionally to communicate study progress, timelines, and key data management insights. Oversee design and standardization of electronic case report forms and data structures. Ensure audit readiness, quality control, and reliability of clinical databases and deliverables. Apply advanced tools and industry standards to enable robust reporting and data visualization. Contribute to process improvements and act as a data management expert in complex problem-solving. Essential Requirements Bachelor's degree in life sciences, computer science, pharmacy, nursing, or a related field. Proven experience managing clinical trial data across multiple studies and delivering to deadlines. Ideally, a minimum of 7+ years' experience in clinical data management. Strong knowledge of clinical trial methodology, good clinical practice, and medical terminology. Advanced ability to analyze and interpret data using programming or graphical user interface tools. Demonstrated leadership and collaboration skills in cross-functional, global team environments. Ability to identify risks, solve complex problems, and implement effective data management solutions. Excellent communication skills, with ability to influence stakeholders across functions and organizations. Experience mentoring colleagues and sharing knowledge to support team and project success. Novartis Compensation and Benefit Summary: The salary for this position is expected to range between 119,700.00 - 222,300.00 USD per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. To learn more about the culture, rewards and benefits we offer our people click_. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $119,700.00 - $222,300.00 Skills Desired Clinical Data Management, Data Architecture, Data Governance, Data Integration, Data Management, Data Profiling, Data Quality, Data Science, Data Strategy, Master Data, Waterfall Model

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases., • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California., • Work with a collaborative team with the ability to work across different areas of the company., • Ability to join a growing company with professional development opportunities. Position Summary The Principal Scientist, Regulatory CMC will report to the Director, Regulatory CMC and be responsible for participating in the development of global Chemistry, Manufacturing and Control (CMC) regulatory strategy for investigational and marketed products and manage the preparation of dossiers in eCTD format. The Principal Scientist will interact with cross-functional teams on CMC regulatory strategy and regional regulatory requirements and interact with CMC subject matter experts (SMEs). Key responsibilities will include contributing to the development of submission strategies for CMC modules and updates, including life cycle management; and generation of submission-ready content for the Quality/CMC sections of all clinical trial and marketing authorization applications for ImmunityBio, Inc. Essential Functions • Prepare and review Module 2 (QOS) and Module 3 documents in accordance with Common Technical Document (CTD) guidances and company standards, • Contribute to the development of global CMC regulatory strategies, • Assist with the preparation or review of documents including pharmacy manuals, protocols, CMC reports, and other documentation, • Provide expert opinion on CMC topics planned or performed, • Contribute to the design of CMC protocols, • Interact with other groups when needed to address CMC related matters, • Assist with the preparation of responses to Health Authority comments and questions pertaining to CMC issues, • Train others on Regulatory Affairs SOPs, processes, and templates for review, preparation, QC, and finalization of documents and major sections of applications as appropriate, • Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities. Education & Experience • Bachelor's Degree in life sciences or technical discipline with 10+ years relevant progressive experience required; or, • Master's Degree in life sciences or technical discipline with 8+ years relevant progressive experience required; or, • Doctorate degree in life sciences or technical discipline with 6+ years relevant progressive experience required, • Experience in the preparation of the submission of CMC modules in eCTD format required, • Familiarity with organizing responses to Health Authority requests required, • Familiarity with regulatory submissions outside of the US desired Knowledge, Skills, & Abilities • Knowledge of Health Authority procedures and guidance regarding document management and electronic submission, • Knowledge of Health Authority CMC guidance documents and requirements, • Proficient in Electronic Document Management Systems, • Ability to work with firm deadlines and adapt quickly to changing requirements and priorities, • Strong organizational skills, written and oral communication skills, and attention to detail, • Knowledge of Biologic-based drugs including cell-based therapies, gene therapies, antibodies and recombinant proteins preferred Working Environment / Physical Environment • This position works on-site in Summit, NJ., • Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval., • This position may need to sit for long periods of time and use various computer programs., • This desk-based role involves the close study of scientific and regulatory documents., • They will work closely with scientific colleagues throughout the day, often on a project-team basis. This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. $170,000 (entry-level qualifications) to $187,000 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed. ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options Health and Financial Wellness Programs Employer Assistance Program (EAP) Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability Healthcare and Dependent Care Flexible Spending Accounts 401(k) Retirement Plan with Company Match 529 Education Savings Program Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks Paid Time Off (PTO) includes: 11 Holidays Exempt Employees are eligible for Unlimited PTO Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases., • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California., • Work with a collaborative team with the ability to work across different areas of the company., • Ability to join a growing company with professional development opportunities. Position Summary The Senior Scientist, Regulatory CMC will assist in the development of global Chemistry, Manufacturing and Control (CMC) regulatory strategy for investigational and marketed products and manage the preparation of dossiers in eCTD format. The Principal Scientist will interact with cross-functional teams on CMC regulatory strategy and regional regulatory requirements and interact with CMC subject matter experts (SMEs). This position will support the development of submission strategies for CMC modules and updates, including life cycle management; and generation of submission-ready content for the Quality/CMC sections of all clinical trial and marketing authorization applications for ImmunityBio, Inc. Essential Functions • Prepare and review Module 2 (QOS) and Module 3 documents in accordance with Common Technical Document (CTD) guidances and company standards., • Support the development of global CMC regulatory strategies., • Assist with the preparation or review of documents including pharmacy manuals, protocols, CMC reports, and other documentation., • Provide input and recommendations on CMC topics planned or performed., • Support the design of CMC protocols., • Interact with other groups when needed to address CMC related matters., • Assist with the preparation of responses to Health Authority comments and questions pertaining to CMC issues., • May train others on Regulatory Affairs SOPs, processes, and templates for review, preparation, QC, and finalization of documents and major sections of applications as appropriate., • Perform ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities. Education & Experience • Bachelor's Degree in life sciences or technical discipline with 6+ years' relevant progressive experience required; or, • Master's Degree in life sciences or technical discipline with 4+ years' relevant progressive experience required; or, • Doctorate degree in life sciences or technical discipline with 2+ years' relevant progressive experience required., • Experience in the preparation of the submission of CMC modules in eCTD format required, • Familiarity with organizing responses to Health Authority requests required, • Familiarity with regulatory submissions outside of the US a bonus Knowledge, Skills, & Abilities • Knowledge of Health Authority procedures and guidance regarding document management and electronic submission, • Knowledge of Health Authority CMC guidance documents and requirements, • Proficient in Electronic Document Management Systems, • Ability to work with firm deadlines and adapt quickly to changing requirements and priorities, • Strong organizational skills, written and oral communication skills, and attention to detail, • Knowledge of Biologic-based drugs including cell-based therapies, gene therapies, antibodies and recombinant proteins desired Working Environment / Physical Environment • This position works on site in Summit, NJ., • Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval., • This position may need to sit for long periods of time and use various computer programs., • This desk-based role involves the close study of scientific and regulatory documents., • This position will work closely with scientific colleagues throughout the day, often on a project team basis. This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. $140,000 (entry-level qualifications) to $154,000 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed. ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options Health and Financial Wellness Programs Employer Assistance Program (EAP) Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability Healthcare and Dependent Care Flexible Spending Accounts 401(k) Retirement Plan with Company Match 529 Education Savings Program Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks Paid Time Off (PTO) includes: 11 Holidays Exempt Employees are eligible for Unlimited PTO Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

Job Description Summary The Medical Science Liaison (MSL) role is a field based, customer-facing, non-promotional medical and scientific position. The MSL's key objective is to create impact through advancing clinical practice within the assigned territory that leads to improved patient outcomes. The MSL must demonstrate deep therapeutic expertise, understand territory and market influences, engage scientifically with Healthcare Providers (HCPs) and medical experts, manage, and develop their territory and execute all relevant activities in alignment with the medical strategic and tactical plan - while functioning within the Novartis Code of Conduct, Ethics/Compliance policies and Working Practice documents. The MSL will Inform and shape medical strategy through application of a curious mindset to collect impactful and actionable insights, understanding the potential strategic impact of critical insights. This territory will be responsible for covering Illinois. The preferable location for the successful candidate would be to reside in the Chicago metropolitan area. Must live within 50 miles of the border of this territory to be considered. Relocation is not available. Role Responsibilities include, but are not limited to • The MSL will leverage scientific expertise and market knowledge to establish and build professional relationships and engage with HCPs (including community physicians, pharmacists, medical experts, nurses, and other healthcare professionals) and other thought leaders in geographical area as aligned with medical strategy, • The primary responsibility of the MSL is to engage with customers - customer engagements may include but are not limited to: emerging data discussions, clinical trial activities, uncovering barriers in patient journey, understanding market dynamics within their territory, exploration of areas of unmet medical need, pipeline discussions, educating on disease state and product, capturing adverse events, and capturing medical insights through all stages of product lifecycle., • Must demonstrate strategic territory vision and ensure appropriate territory identification, mapping, and planning of Medical Engagements (MEs) and Key Accounts as aligned to medical strategy and in collaboration with internal Novartis colleagues. This includes: a. identification of key stakeholders with influence on the patient journey and in the disease space throughout the product development lifecycle to establish strategies for education, engagement, and partnership b. identification of opportunities for partnership with academic centers, centers of excellence, and/or systems of care to drive impact within the assigned territory c. identification of opportunities to involve HCPs or MEs when a specific medical need is identified (e.g., publications, clinical trial participation, etc.) d. identification of opportunities for internal collaboration with other Novartis stakeholders to drive forward therapeutic area, clinical, or product goals as appropriate* Provide clinical trial support for company sponsored trials facilitating relevant medical activities and working cross-functionally with Medical Affairs and Clinical Operations colleagues. • Regularly and effectively collaborates with internal colleagues (e.g., HEOR, access, marketing, commercial, sales) within the assigned therapeutic area and territory to advance clinical practice while maintaining customer centricity and a One Novartis approach in accordance with Novartis compliance standards., • Maintain in-depth knowledge of assigned therapeutic area and Novartis compounds to serve as a medical resource to customers and internal colleagues (in accordance with Working Practice Documents)., • Maintain in-depth knowledge of internal policies and external regulations (e.g., field medical Working Practice Document (WPD), travel policy, expense policy, state and local laws, institutional policies) and how they affect day-to-day responsibilities., • Execute all administrative responsibilities and training (e.g., Veeva CRM, voicemail, e-mail, expense reports, compliance modules, etc.) in a timely manner, including profiling of core customers and ensuring up-to-date information in the CRM., • Champion emerging responsibilities as strategic priorities and territory needs evolve, • Proactively drive personal and professional development. Job Description Education: Graduate degree in science or healthcare required; doctoral degree preferred (MD, PhD, DNP, PharmD, etc) Experience for Manager Level: • 0-3 years of experience in a Field Medical position within the pharmaceutical industry or as an MSL is required OR, • 3-5 years of relevant medical affairs, clinical research, or related experience in a scientific or clinical setting preferred. Previous experience in assigned or related therapeutic area is preferred. Experience for AD Level: • Minimum of 3 years' experience in a Field Medical-based position within the pharmaceutical industry or as an MSL is preferred OR, • 5-7 years of relevant medical affairs, clinical research, or related experience in a scientific or clinical setting required. Previous experience in assigned or related therapeutic area is preferred. Experience all levels: • Strong clinical knowledge including pharmacotherapy, treatment guidelines, clinical research processes, medical expert engagement strategies, and FDA promotional guidelines, regulations, and ethical guidelines applied to the pharmaceutical industry is required., • Candidates will perform their duties in accordance with applicable law, regulations, and Novartis policies., • Works within Ethics, Compliance and Promotional policies (Novartis & Federal) and ensures those around him/her do the same, • Works to ensure a diverse and inclusive environment free from all forms of discrimination and harassment, • Adherence with Company policies, state and federal laws and regulations, • Field-Based Region covering the state of Illinois. Candidate must reside within territory, or within a reasonable daily commuting distance of 50 miles from territory border., • The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager, • Field based, customer-facing position majority of the time with approximately 60-70% travel required to achieve performance and business objectives (face to face, virtual, email, telephone, etc.). NOTE: Above level experience criteria are not an exhaustive list Field roles with a dedicated training period only: The individual hired for this role will be required to successfully complete certain initial training, including home study, in eight (8) or fewer hours per day and forty (40) or fewer hours per week. Field roles with a company car: Driving is an essential function of this role, meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions, if an accommodation can be provided without eliminating the essential function of driving. The pay range for this position at commencement of employment is expected to be between; for Manager: $145,600 - $270,400 and for AD: $160,300 - $297,700 year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. To learn more about the culture, rewards and benefits we offer our people click _. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $160,300.00 - $297,700.00 Skills Desired Building Constructions, Business Analysis, Business Networking, Clinical Protocols, Clinical Research, Clinical Study Reports, Communication, Curious Mindset, Disease Management, Diversity and Inclusion (D&I), Drug Development, Epidemiology, Medical Information, Medical Research, Medical Writing, Microsoft Word, Phase Iv Clinical Trial, Product Placement, Scientific Support

Company Overview ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases., • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California., • Work with a collaborative team with the ability to work across different areas of the company., • Ability to join a growing company with professional development opportunities. Position Summary The Associate Director, Health Authorities will aid the advance of global clinical regulatory compliance for investigational and marketed products and manage the preparation, review, and finalization of submission packages and responses to Health Authorities. This position will contribute to the preparation of INDs, CTAs, BLAs, MAAs, and any other application for health authorities in line with local requirements. Essential Functions • Lead Health Authorities direct reports by delegating projects, establishing and meeting timelines, and ensuring high quality work products, • Manage the day-to-day activities of staff to include the hiring and training of new team members, coaching employees and monitoring performance., • Review clinical data, reports, and summaries for compliance with the protocol, statistical analysis plan, monitoring guidelines, data management plan, and any other clinical trial associated document, • Provide input to the design and reporting of clinical studies sponsored by IBRX, • Manage the preparation of the relevant clinical sections of written summaries for regulatory submissions including INDs, CTAs, NDAs, BLAs, MAAs, and any other applications., • Create and maintain project plans for health authorities operations, • Participate in cross-functional teams and provide support to others in the preparation, analysis, and documentation of studies, • Lead external stakeholder engagement throughout the submission lifecycle, coordinating with CROs, external regulatory consultants, and subject matter experts / key opinion leaders to gather data, craft highquality RFI responses, and foster constructive agency relationships, • Prepare and assign responses to Health Authority comments and questions pertaining to clinical issues. Maintain timelines on responses and assemble the final, completed submission package., • Serve as a trainer for Regulatory Affairs SOPs, processes, and templates for review, preparation, QC, and finalization of documents and major sections of applications, • Ensure continuous monitoring of, and incorporation of, the most recent regional and local healthauthority guidances; interpret amendments and apply updated requirements to all regulatory dossiers to mitigate agency queries and preserve submission integrity, • Oversee versioncontrol governance by supervising a centralized document repository, defining namingconvention standards, authorizing changetracking procedures, and approving final module versions prior to electronic upload to ensure auditready documentation, • Develop and maintain productdevelopment road maps based on projected approval dates, • Performs ad-hoc and cross-functional duties and/or projects, as assigned, to support business needs and provide developmental opportunities. Education & Experience • Bachelor's Degree in life sciences or technical discipline with 10+ years of relevant progressive experience required; or, • Master's Degree in life sciences or technical discipline with 8+ years of relevant progressive experience required; or, • Doctorate degree in life sciences or technical discipline with 6+ years of relevant progressive experience required., • Experience managing staff required, • Experience in the management and preparation of the submission of clinical modules in eCTD format required., • Experience in medical writing, • Experience with organizing responses to Health Authority information requests required., • Experience with regulatory submissions outside of the US preferred Knowledge, Skills, & Abilities • Expert knowledge of Health Authority guidance documents and requirements, • Strong leadership skills with the ability to direct and develop professional staff, • Expert knowledge of clinical research, Good Clinical Practices, and regulatory requirements and guidelines, • Expert knowledge of clinical documentation, • Ability to work with firm deadlines and adapt quickly to changing requirements and priorities, • Strong organizational skills, written and oral communication skills, and attention to detail, • Ability to successfully manage multiple changing deadlines and operate in ambiguity Working Environment / Physical Environment • This position works on site in Summit, NJ., • Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval, • This position may need to sit for long periods of time and use various computer programs, • This desk-based role involves the close study of scientific and regulatory documents, • This position will work closely with scientific colleagues throughout the day, often on a project-team basis This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. $185,000 (entry-level qualifications) to $203,500 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options Health and Financial Wellness Programs Employer Assistance Program (EAP) Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability Healthcare and Dependent Care Flexible Spending Accounts 401(k) Retirement Plan with Company Match 529 Education Savings Program Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks Paid Time Off (PTO) includes: 11 Holidays Exempt Employees are eligible for Unlimited PTO Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day * We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

Job Description Summary #LI-Remote This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require up to 30% travel. Looking to turn breakthrough science into transformative treatments? Join our team as a SSO Field Monitoring Area Head, where you will play a critical leadership role in advancing clinical trial execution across your geographic Area. In this highly visible role, you will drive field strategy, optimize site engagement, and lead high-performing teams to deliver trials with quality, speed, and impact-helping bring innovative medicines to patients worldwide. Job Description Key Responsibilities • Lead and Develop Field Teams: Provide leadership for CRAs, CRA Managers, and FSP partners, ensuring strong functional management, coaching, and performance excellence., • Drive Trial Execution Excellence: Ensure trials are delivered against enrollment targets, timelines, and budgets, using data-driven insights and KPIs to guide decision-making and performance optimization, • Strategic Field Planning & Execution: Design and implement field strategies that enhance site engagement, patient recruitment, and overall trial quality in alignment with global SSO objectives., • Optimize Resource Allocation: Collaborate with the CRA Managers and FSP Vendor Line Managers to strategically allocate field monitoring resources and ensure alignment with portfolio priorities., • Strengthen Monitoring Quality & Compliance: Ensure adherence to ICH/GCP, regulatory requirements, SOPs, and data standards while proactively addressing risks and compliance challenges., • Advance Monitoring Excellence: Oversight of team's Field Monitor Accompanied Visit Plan, assessing monitoring quality and driving continuous improvement through targeted development and issue resolution., • Collaborate Cross-Functionally: Partner with global and regional stakeholders to support end-to-end trial delivery and contribute to broader clinical operations initiatives., • Lead Change and Innovation: Champion innovation, digital enablement, and future-ready capabilities to evolve field monitoring strategies and trial delivery models. Essential Requirements • Bachelor's degree in a scientific or health-related discipline, • Fluent in written and spoken English, • 10+ years' experience in clinical study management, including progressive leadership responsibility, • 5+ years' experience managing direct reports, • Proven experience in Vendor and FSP management; leading internal and external clinical teams; Site monitoring and clinical quality compliance; Clinical trial budgeting and financial, • Deep understanding of clinical drug development, with strong expertise in monitoring and trial execution, • Demonstrated ability to lead teams, solve complex problems, and navigate compliance challenges with accountability, • Strong knowledge of global clinical standards (ICH/GCP), regulatory authorities (FDA, EMA), and applicable local regulations Desirable Requirements • Advanced degree (e.g., MSc, PhD, or equivalent) The salary for this position is expected to range between $176,400 and $327,600 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves. EEO Statement: The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Salary Range $176,400.00 - $327,600.00 Skills Desired Clinical Research, Clinical Trials, People Management, Program Management, Regulatory Compliance, Resource Management (Organizational), Risk Management

Provided ad hoc research assistant support to the clinical trial project teams. Maintain and prepare for final archival of documents relevant to the assigned clinical trials, and assist the corporate archivist in assembling and archiving such documents. Education or experience must demonstrate the a

Job DescriptionCompany Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description The Associate Director, Patient Centered Outcomes Research, is responsible for the design and execution of strategically-focused and innovative patient experience data (PED) evidence to support optimization of product registration, access & reimbursement, and clinical practice in collaboration with HEOR Strategy and other functions (e.g., Clinical Development & Operations, Regulatory, Commercial). The Associate Director, Patient-Centered Outcomes Research, will support multiple programs across therapeutic areas and cultivate strong partnerships to enable effective cross-functional collaboration with other product team members from internal groups including HEOR-Strategy, Clinical Development and Operations, Biostatistics, Regulatory Affairs, Medical Affairs, and the Commercial organization. In addition, the Associate Director will support collaborations with external partners (e.g., industry consortiums, key opinion leaders, research organizations, patient advocacy groups). The Associate Director represents HEOR at global regulatory and payer / HTA meetings and may lead and/or support negotiations in collaboration with cross-functional team members to drive internal strategy and alignment with global regulatory & reimbursement agencies. He / She serves as a subject matter expert (SME) on PED and patient-centered measurement strategies within HEOR and AbbVie to drive a patient-centric culture and adoption/uptake of standards and best practices for PED. The Associate Director will be responsible for several programs across AbbVie’s portfolio (e.g., spanning multiple products/ indications). Additional responsibilities for the Associate Director include developing annual strategic planning of PED aligned with TA / asset strategy and managing multiple projects and vendors to execute PED for their respective TA responsibilities. *This position can sit anywhere in the U.S. Responsibilities • Responsible for execution of global PED evidence generation and stakeholder engagement strategies that encompasses innovative research aligned with overall asset strategy across multiple therapeutic areas, • Leads management of projects to ensure timely execution of PED research to characterize patient outcomes, identify patient preferences and unmet needs, inform patient-focused measurement strategies, and develop innovative patient-relevant outcomes measures and endpoints to differentiate AbbVie’s portfolio and meet business and global needs, • Supports alignment of strategy with HEOR-Strategy counterparts and communicates strategy and translates results cross-functionally to key cross-functional teams that are part of Pipeline Commercial Model to facilitate alignment and integration of PED plans into the broader Integrated Evidence Plans, • Ensures the scientific quality and integrity of COA research through development of rigorous qualitative and quantitative study research proposals, protocols, analysis plans and reports, • Leads integration of COA measurement strategy into clinical development programs through clinical trial program support (e.g., protocol/SAP content development, results interpretation and CSR development) and ensures appropriate implementation of COAs on eCOA platforms in global programs Leads development, validation, and implementation of COAs measures for randomized controlled trials (RCTs) / observational studies, • Leads/contributes to strategy and development of content for regulatory and reimbursement submissions regarding PED and patient-relevant endpoints and leads/participates in regulatory and reimbursement discussions and negotiations to optimize registration approval, product labeling & promotion and patient access decisions, • Develops strategic scientific communication plan including submission and presentation of research in peer-reviewed journals and at medical / methodological congresses, • Serves as internal SME on technical specialty areas to identify new methodologies and advancements in the field (e.g., COA methods, regulatory requirements to obtain COAs on labels, industry trends), • Develops and delivers standards/best practices and educational resources for functions across AbbVie to drive the integration of patient voice in development programsQualifications, • Advanced degree in Psychology, Epidemiology, Statistics, Public Health, Health Economics and, • Outcomes Research (HEOR) or related discipline (MS, MPH, PharmD, PhD) preferred, • Minimum of 5 years of experience required, with relevant pharmaceutical industry or consulting experience in patient experience data research; clinical outcome assessment / patient reported outcome development, psychometric validation, and implementation; and medical product development and trial design, • Demonstrated ability in evaluation & development of PED from conceptualization through negotiations by global authorities, • Experience in preparing regulatory & HTA submissions, • Excellent interpersonal skills with an ability to leverage deep expertise to understand, respond and influence effectively across multiple internal and external customers, • Demonstrated ability to manage multiple priorities in rapidly changing environment, • Excellent written and verbal communication skills, • Experience in handling delivery of services across complex matrix environments and on a global level, • Excellent project management skills, • Demonstrated experience / knowledge of the pharmaceutical industry (knowledge of regulatory/compliance frameworks) and clinical trial design, • Knowledge of regulatory & HTA requirements for patient-centered endpoints, • Ability to effectively interpret and communicate research results to internal and external audiences, • Ability to work collaboratively to leverage other HEOR capabilities (Strategy, Geographies, other Centers of Expertise [CoEs] – Economic Modeling, Meta-Research, RWE Analytics), • Develop standards and respond quickly to business questions, • Travel – Position requires up to 15% travel Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our long-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html

Job DescriptionCompany Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description The Medical Affairs (MA) organization provides patients, healthcare providers and payers everywhere with the practical and clinically relevant information and solutions they need to use AbbVie products safely and effectively, throughout the product lifecycle and the patient’s journey. The Scientific Director / Medical Director provides medical and scientific input into strategic and operational medical affairs activities for AbbVie’s Oncology portfolio such as: health-care professional and provider interactions (Payers, Patients, Prescribers, and Providers); generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, data, guidelines, and value proposition); safeguarding patient safety (risk minimization activities and safety surveillance activities). Works closely with commercial teams to provide strategic medical input into core brand (product) strategies, and may support medical and marketing activities (promotional material generation and product launches) and market access. Collaborates with clinical development on Medical Affairs support of priority trials. This position can be based at the following locations and will follow a hybrid model of 3 days/week onsite: Mettawa, IL; Florham Park, NJ; Irvine, CA; San Francisco, CA. Responsibilities • With oversight, initiates medical affairs activities, generation and dissemination of data supporting the therapeutic area scientific strategy, • Provides scientific/medical education to all relevant internal stakeholders related to therapeutic area or disease specific information., • Develops and executes Medical Affairs support of priority clinical development trials., • Contributes to the development of and leads the execution of the Medical Education / Advisory Board & EE Engagement Plan generation in line with TA plan. Lead the individual (Global) Conference planning and execution., • Generates clinical and scientific data per evidence gap assessment., • Acts as a clinical interface and actively solicits opinion through leader interactions related to the molecule and disease area; partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate., • May be responsible for performing the accurate and detailed medical review of complex advertising and promotional materials for assigned therapeutic area(s) within Medical Affairs. Provides timely and accurate reviews of promotional materials in accordance with established policies and practice standards, including regulatory guidelines to meet customer needs., • May interact with and coordinates appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc.) as they relate to on-going medical affairs projects., • May assist as consultant and liaison with other corporations when working under licensing agreements and/or in the evaluation of new business development opportunities., • Represents AbbVie at external meetings including investigator meetings, scientific association meetings, etc., • Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities. Qualifications Position will be commensurate with experience. • Scientific Director:, • Bachelor’s Degree in the sciences. Advanced Degree PhD, PharmD, PA or NP preferred. Residency or additional post doctorate experience preferred., • 5-7+ years of experience in the pharmaceutical industry or equivalent; substantial understanding of relevant therapeutic area required., • Medical Director:, • Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D.). Relevant therapeutic specialty in an academic or hospital environment preferred. Completion of residency and/or fellowship preferred., • 0-2+ years of experience in the pharmaceutical industry or equivalent., • Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in the design of protocols preferred., • May have performed protocol design in the academic environment and/or acted as an assistant PI., • Interactions normally require the ability to gain cooperation of others, conduct presentations of technical information concerning specific projects and schedules, etc., • Ability to interact externally and internally to support global business strategy. Must possess excellent oral and written communication skills., • Works with some supervision and guidance. Exercises judgment within well-defined practices and policies. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of thisposting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location,and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our long-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless anduntil paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html

Job DescriptionCompany Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description AbbVie Data Science is the best-in-class team within its cross-industry peer group and is responsible for bringing people, process, and technology together to generate business value from clinical trials data. Our operational model is exemplified through execution and innovation. This role is key to ensuring successful delivery against the program- and study-level accountabilities assigned to Data and Statistical Sciences. Responsibilities • Aligns DSS study teams with program- and study-level strategies. Assigned programs may include programs that are of low complexity and size. For assigned programs and studies, leads the DSS Study Team and represents DS as a member of the cross-functional study team, • For assigned programs and studies, acts as single point of contact and accountable operational lead from DSS. Coordinates associated DSS study teams to meet operational objectives. Engages and connects global functional and cross-functional teams at the study level, • Interacts with and influences cross-functional team members to achieve program objectives, • Utilizes operational analytics and project management tools to optimize execution of programs and studies, to manage internal and external resources, to track study progress, and to prepare study status reports. Anticipates and identifies issues that could affect timelines or quality and develops options and solutions, • Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to functional quality standards. Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development. If assigned, participates as the DS study owner in regulatory inspections and internal quality audits, • Participates in oversight of vendors and provides feedback related to clinical trial operations, issues, and trends in performance, • Responsible for coaching and mentoring team members, • Leads DSS innovation and process improvement initiatives and participates in cross-functional initiatives, • Conducts study execution “lessons learned” across functions, • May include indirect supervision of employee as well as supervision of work of contract resourcesQualifications, • Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent. Master’s preferred. PMP Certification or Lean Six Sigma Green Belt desired., • Must have 6+ years of pharma / clinical research / data management / health care experience or 8+ years of project management experience (and / or applicable work experience)., • In-depth understanding of clinical trial processes and clinical technology. Management of a clinical trial from initiation through to completion in a lead role is preferred, • Demonstrated performance as a functional leader, • Demonstrated ability to influence others without direct authority, • Demonstrated ability to successfully coach / mentor in a matrix environment, • Demonstrated effective communication skills, • Demonstrated effective analytical skills Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of thisposting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location,and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our long-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless anduntil paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html

Job DescriptionCompany Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description Provides specialist medical/scientific strategic and operational input into core medical affairs activities such as: health-care professional/provider interactions (Payers, Patients, Prescribers, and Providers); generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, data, guidelines and value proposition); safeguarding patient safety (risk minimization activities / safety surveillance activities). Works closely with commercial teams to provide strategic medical input into core brand (product) strategies, and to support medical affairs, marketing activities (promotional material generation and product launches) and market access. • Provides scientific and technical support for assigned multiple myeloma products; deliver scientific presentations; develops and maintains professional and credible relationships with, key opinion leaders; actively participate in relevant Brand Teams and helps develop medical affairs strategies for assigned multiple myeloma products; develop innovative research concepts for clinical data generation; provide relevant scientific and technical training., • In cooperation with other medical departments, Marketing, RA, Clinical and other functional areas, provides leadership, oversight and support for assigned multiple myeloma products/projects., • Drives medical affairs related launch activities, identifies launch risks and develops & executes mitigations strategies and makes sure that medical affairs considerations are heard during regulatory negotiations, • Drives the execution of the molecule and disease specific publication plan based on the unmet needs, evolving data and evolving treatment landscape through a cross functional collaboration with publication lead and clinical development team, • Drives Medical Affairs strategies and be a key internal contact/subject matter expert. Responsible for delivery of strategic alignment plan, brand plan, gap analysis and integrated tactical plan., • Develops and executes innovative research concepts for clinical data generation; provides relevant scientific and technical training to internal teams globally, • Ensures appropriate selection of investigator initiated studies and maintains oversight for appropriate execution., • Collaborates closely with HEOR and V&A team to develops and co-executes HEOR & access strategy., • May develop of scientifically accurate marketing materials, medical education programs, advisories, and symposia, • May assist with the scientific review, development, execution and communication of area/global medical affairs sponsored or supported clinical research activities., • Keeps abreast of evolving multiple myeloma treatment landscape as well as competitive landscape, other professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource and is able to translate this info into strategic implications., • May lead cross functional teams in development and execution of strategic initiatives requiring integration of multiple subprojects within the therapeutic area or Medical Affairs function., • Provides guidance to cross-functional team members to aid in the development of promotional materials., • Provides timely and accurate reviews of promotional strategies and tactics in accordance with established policies and practice standards, including regulatory guidelines to meet customer needs, • Oversees the work of a small team of Scientific/Associate Scientific Directors or Medical/Associate Medical directors, • Coordinates induction, mentoring, training, and development of others., • Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities.Qualifications For US/Global Senior Medical Director: • Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D). Relevant multiple myeloma experience in an academic or hospital environment preferred. Completion of residency and/or fellowship is preferred., • Minimum of 5 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent. 6+ years of experience is preferred., • Substantial understanding of multiple myeloma required., • Knowledge of clinical trial methodology, data analysis and interpretation, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols., • Ability to run a clinical study independently with little supervision., • Proven leadership skills in a cross-functional global team environment, • Ability to interact externally and internally to support global business strategy., • Must possess excellent oral and written English communication skills., • People leadership experience preferred For US/Global Scientific Director: • Advanced Degree PhD or PharmD., • Typically, 10-15 years of experience in the pharmaceutical industry or equivalent; substantial understanding of multiple myeloma required., • 7-10 years of experience in Medical Affairs with Global/US Medical Affairs experience highly preferred., • Minimum of 4 years of clinical trials direct management experience in the pharmaceutical industry or academia or equivalent is preferred., • Knowledge of clinical trial methodology, data analysis and interpretation, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols., • Ability to run a clinical or real-world study independently with little supervision., • Proven leadership skills in a cross-functional global team environment, • Must possess excellent oral and written English communication skills., • People leadership experience preferred Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our long-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html

Job DescriptionCompany Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description The Scientific Director / Senior Medical Director provides specialist medical and scientific input into core strategic and operational medical affairs activities such as: health-care professional and provider interactions; generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, scientific communications, and value proposition) and safeguarding patient safety (risk minimization activities and safety surveillance activities). Works closely with sales, marketing, and commercial teams to provide strategic medical input into core brand (product) strategies, and to support medical affairs, marketing activities (promotional material generation and product launches) and market access. This position is ideally based from our Mettawa, IL or Florham Park, NJ sites but other U.S. sites may be considered. Must follow a hybrid schedule of 3 days/week onsite. Key Responsibilities: • Initiates medical affairs activities including data generation and dissemination strategy, development of Global Medical Affairs strategy, delivering the Medical Functional Plan, Brand Plan and working with Area and Affiliates to ensure execution of strategy., • Responsible from Medical Affairs for the design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, and Regulatory Submissions and responses., • Has overall responsibility for oversight of the Medical Affairs-led clinical studies, monitoring overall study integrity and review, interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule. Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific activities with internal stakeholders and leadership as they relate to ongoing clinical projects., • M.D.s may participate in design and execution of clinical trial safety; scientifically accountable for resolution of safety issues, safety monitoring, and other scientific reports reported to regulatory authorities. Review and assess all Adverse Events (AE’s) and Serious Adverse Events (SAE’s)., • Acts as a clinical interface and actively solicits opinion through leader interactions related to the molecule and disease area; partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate., • Assist in the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia. Assists with the scientific review, development, approval, execution, and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities., • Interact with and coordinates appropriate scientific and medical activities with internal stakeholders (i.e., commercial, market access, HEOR, clinical operations, clinical development, regulatory, etc…) as they relate to on-going medical affairs projects. Serve as the scientific team interface for key regulatory discussions., • Provide scientific/medical education to investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information. Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource., • Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities., • Responsible for understanding regulatory requirements related to clinical studies and global drug development and accountable for complying with those requirements.Qualifications Experience Requirements Position will be commensurate with experience. Scientific Director • Advanced Degree PhD or PharmD. Additional post doctorate experience highly preferred., • Typically, 10-15 years of experience in the pharmaceutical industry or related., • 7-10 years of experience in Medical Affairs with Global Medical Affairs experience highly preferred. Senior Medical Director • Medical Doctorate (M.D.) or equivalent (D.O. or non-US equivalent of M.D.). Relevant therapeutic specialty in an academic or hospital environment preferred. Completion of residency and/or fellowship preferred., • Minimum 2 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent. 5 years of experience is preferred. Qualifications: • Substantial understanding of relevant therapeutic area required. Direct subject matter expertise in multiple myeloma highly preferred., • Knowledge of clinical trial methodology, data analysis and interpretation, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols., • Proven leadership skills in cross-functional global team environment, • Ability to interact externally and internally to support global business strategy, • Must possess excellent oral and written English communication skills Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this postingbased on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more orless than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paidand may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html

Job Description About Hand Over Hand LLC At Hand Over Hand, we believe every child deserves the opportunity to thrive. As a leading provider of Applied Behavior Analysis (ABA) therapy, we partner with families to empower children with autism and developmental disabilities. Our work is deeply mission-driven: we’re here to make a difference in the lives of children and their communities. Our culture is collaborative, supportive, and purpose-filled. We celebrate growth of our team, of our families, and of ourselves. If you’re passionate about early childhood development and want to do meaningful, hands-on work that truly changes lives, you’ll feel right at home here. Why This Role Matters This isn’t just another clinical role; it’s a chance to help children, adolescents, and adults thrive where life actually happens. As a Registered Behavior Technician, you’ll provide direct ABA services in home, school, and community settings, supporting them through meaningful routines like learning in the classroom, transitioning between activities, and building independence at home. Working under the supervision of a Board Certified Behavior Analyst (BCBA), you’ll implement treatment plans with care and consistency, helping children strengthen communication, behavior, emotional regulation, and daily living skills in the environments that matter most to them. How You’ll Make an Impact • Deliver care where it matters most: Provide one-on-one ABA services in home, school, and community settings., • Help skills generalize naturally: Support learning that transfers into everyday routines, not just therapy sessions., • Strengthen independence: Help build communication, self-help, social, and behavioral skills that support long-term success., • Partner with families and schools: Collaborate with caregivers, teachers, and school staff to support consistency across environments., • Promote dignity and inclusion: Help individuals participate meaningfully in daily routines and community life with confidence and support., • Grow professionally: Receive structured feedback, supervision, and coaching to deepen your clinical skills. What You’ll Own & Elevate • Implement individualized ABA treatment plans designed by the supervising BCBA., • Deliver one-on-one services in home, school, and community environments while maintaining clinical fidelity and professionalism., • Use evidence-based teaching strategies such as Natural Environment Teaching (NET), Discrete Trial Training (DTT), prompting, reinforcement, and task analysis., • Support behavior reduction and skill acquisition goals in real time, while ensuring safety and respect., • Collect accurate data during sessions and document notes/progress updates in a timely and compliant manner., • Communicate observations and progress to the BCBA and clinical team., • Participate in required supervision, training, and team meetings., • Maintain confidentiality and follow HIPAA, mandated reporting, and professional standards. Who You Are • Compassionate, patient, and energized by helping others succeed., • Comfortable working independently in field-based settings while staying accountable to clinical standards., • Calm, steady, and safety-minded, especially during challenging behaviors or high-stress situations., • A strong communicator who can work respectfully with families, school teams, and clinical leadership., • Reliable, consistent, and proud to be a stable part of a support system., • Open to coaching and excited to grow professionally. What You Bring • High school diploma or equivalent (required)., • Active Registered Behavior Technician (RBT) certification through the BACB (required)., • Experience working with children, adolescents, or adults with autism or developmental disabilities (preferred)., • Experience supporting children in home-based, school-based, or community settings (preferred)., • Ability to pass background checks, clearances, and health screenings required by state regulations and childcare centers., • Valid driver’s license and reliable transportation (strongly preferred for travel between client locations). Why You’ll Love Working Here • Competitive Salary (with OT Eligibility): Based on experience and location., • Supportive clinical supervision: Ongoing guidance from experienced BCBAs., • Professional development: Paid training, supervision, and opportunities for growth., • Meaningful work: Everything you do helps children gain skills that last a lifetime., • Collaborative culture: Work alongside passionate clinicians who value teamwork and compassion., • Purpose & pride: Be part of a team that celebrates progress, big and small, every single day. Ready to make a real-world difference in a child's or an adult’s daily life? Apply today and join Hand Over Hand LLC and help build skills, confidence, and independence; one meaningful moment at a time. Hand Over Hand LLC is an EEO Employer: All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, sex, religious creed, disability, or any other category protected under law. Multiple Schedules Available.

Job Description About Hand Over Hand LLC At Hand Over Hand, we believe every child deserves the opportunity to thrive. As a leading provider of Applied Behavior Analysis (ABA) therapy, we partner with families to empower children with autism and developmental disabilities. Our work is deeply mission-driven: we’re here to make a difference in the lives of children and their communities. Our culture is collaborative, supportive, and purpose-filled. We celebrate growth of our team, of our families, and of ourselves. If you’re passionate about early childhood development and want to do meaningful, hands-on work that truly changes lives, you’ll feel right at home here. Why This Role Matters This isn’t just another clinical role; it’s a chance to help children, adolescents, and adults thrive where life actually happens. As a Behavior Technician, you’ll provide direct ABA services in home, school, and community settings, supporting them through meaningful routines like learning in the classroom, transitioning between activities, and building independence at home. Working under the supervision of a Board Certified Behavior Analyst (BCBA), you’ll implement treatment plans with care and consistency, helping children strengthen communication, behavior, emotional regulation, and daily living skills in the environments that matter most to them. How You’ll Make an Impact • Deliver care where it matters most: Provide one-on-one ABA services in home, school, and community settings., • Help skills generalize naturally: Support learning that transfers into everyday routines, not just therapy sessions., • Strengthen independence: Help individuals build communication, self-help, social, and behavioral skills that support long-term success., • Partner with families and schools: Collaborate with caregivers, teachers, and school staff to support consistency across environments., • Promote dignity and inclusion: Help individuals participate meaningfully in daily routines and community life with confidence and support., • Grow professionally: Receive structured feedback, supervision, and coaching to deepen your clinical skills. What You’ll Own & Elevate • Implement individualized ABA treatment plans designed by the supervising BCBA., • Deliver one-on-one services in home, school, and community environments while maintaining clinical fidelity and professionalism., • Use evidence-based teaching strategies such as Natural Environment Teaching (NET), Discrete Trial Training (DTT), prompting, reinforcement, and task analysis., • Support behavior reduction and skill acquisition goals in real time, while ensuring safety and respect., • Collect accurate data during sessions and document notes/progress updates in a timely and compliant manner., • Communicate observations and progress to the BCBA and clinical team., • Participate in required supervision, training, and team meetings., • Maintain confidentiality and follow HIPAA, mandated reporting, and professional standards. Who You Are • Compassionate, patient, and energized by helping others succeed., • Comfortable working independently in field-based settings while staying accountable to clinical standards., • Calm, steady, and safety-minded, especially during challenging behaviors or high-stress situations., • A strong communicator who can work respectfully with families, school teams, and clinical leadership., • Reliable, consistent, and proud to be a stable part of a support system., • Open to coaching and excited to grow professionally. What You Bring • High school diploma or equivalent (required)., • Willingness to obtain Registered Behavior Technician (RBT) certification within the first 120 days of employment (required)., • Experience working with children, adolescents, or adults with autism or developmental disabilities (preferred)., • Experience supporting children in home-based, school-based, or community settings (preferred)., • Ability to pass background checks, clearances, and health screenings required by state regulations and childcare centers., • Valid driver’s license and reliable transportation (strongly preferred for travel between client locations). Why You’ll Love Working Here • Competitive Rate (with OT Eligibility): Based on experience and location., • Supportive clinical supervision: Ongoing guidance from experienced BCBAs., • Professional development: Paid training, supervision, and opportunities for growth., • Meaningful work: Everything you do helps individuals gain skills that last a lifetime., • Collaborative culture: Work alongside passionate clinicians who value teamwork and compassion., • Purpose & pride: Be part of a team that celebrates progress, big and small, every single day. Ready to make a real-world difference in a child's or an adult’s daily life? Apply today and join Hand Over Hand LLC and help build skills, confidence, and independence; one meaningful moment at a time. Hand Over Hand LLC is an EEO Employer: All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, sex, religious creed, disability, or any other category protected under law.

Job DescriptionJob Title: Lab Technician Job Description As a Lab Technician, you will be responsible for setting up and conducting lab tests in compliance with established protocols, SOPs, and applicable regulations such as GDPs, GMPs, and GCPs. Your role will involve preparing and organizing study documentation, performing station and instrumentation duties, and conducting pre-study meetings. You will play a crucial role in ensuring that staff understand and perform their duties according to protocols and SOPs. Responsibilities • Set up and conduct lab tests ensuring compliance with protocols, SOPs, GDPs, GMPs, and GCPs., • Prepare pH tests within the whirlpool to test products., • Organize and maintain all study documentation forms, including drafting protocol amendments and other study-specific documents., • Perform station and instrumentation duties on assigned studies, including the collection and recording of clinical information., • Prepare for and conduct pre-study meetings, ensuring staff are informed and compliant with protocols and SOPs., • Respond to queries from Quality Assurance and Statistics Departments., • Prepare and manage all Test Material for studies., • Deliver excellent customer service to clients and panelists, maintaining positive interactions with peers and supervisors.Essential Skills, • Degree in Chemistry, • Proficiency in wet chemistry techniques, especially pH testing, • Flexibility in clinical trial settings, • Strong data entry skillsAdditional Skills & Qualifications, • Experience in a sunscreen department, • Reliability, attention to detail, and accountability, • Ability to handle stress with humility, • Lab experience, • Self-starter and team player, • Experience in the service industry (e.g., waitress, bartender, hotel)Work Environment The work schedule is primarily Monday through Friday, 8:30 AM to 5:00 PM, with occasional Saturdays. The role involves performing physical tasks such as wet and dry tests, multi pours, and cleaning the whirlpool. Testing involves overseeing waterproof claims of sunscreen by managing the whirlpool for 20 minutes and conducting pH testing of the water. The lab environment requires focus and prohibits phone use during work hours. Flexibility around the standard schedule is necessary, and the role offers an introduction to research. Job Type & Location This is a Contract to Hire position based out of Elizabeth, NJ. Pay and Benefits The pay range for this position is $23.00 - $23.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program, • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Elizabeth,NJ. Application Deadline This position is anticipated to close on Jun 5, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.

Job Description Job Title: Registered Dental Assistant Department: Operations Reports to: Dental Practice Manager FLSA Status: Non-Exempt Compensation Information: $28.00-$32.00 per hour Company Overview ProSmile is the fastest growing dental organization on the East Coast and Midwest. Our premier DSO is led by world class dentists who understand what highly skilled dentists and dental professionals need to grow a practice while focusing on delivering the best-in-class clinical care to their patients. We offer up-to-date equipment and technology, experienced and friendly staff, and dentists who truly care about their patients, as well as competitive pay and, where applicable, a benefits package that includes medical, dental, vision, 401(k), training, and career growth opportunities. Position Summary As a Registered Dental Assistant, you will help support the clinical needs of our patients and doctors. The duties of a Dental Assistant are very important for the functionality of our dental offices. These duties can include patient care, recordkeeping, and appointment scheduling. As a Registered Dental Assistant, you will work under the supervision of dentists and work closely with dental hygienists in their day-to-day activities. Duties and Responsibilities The duties include, but are not limited to: • Clearly demonstrate knowledge of dental instruments and assist the dentist in rendering patient care chairside., • Maintaining inventory control in the operatories where treatment is rendered by the Provider, • Adhering to OSHA, HIPAA, and CDC guidelines, • Deliver world class patient interactions related to scheduling, follow up treatment, post-surgical information and record keeping, • Be able to perform basic lab procedures such as taking impressions, pour models, and preparing cases for external labs., • Remove excess cement from crowns or other restorations and orthodontic appliances;, • Fabricate and cement temporary crowns and bridges after preparation of tooth (teeth) by a dentist., • Placing and removing rubber dam and clamp., • This does not include intra-oral occlusal adjustment;, • Trial size (pre-select) orthodontic bands, wires, stainless steel crowns and temporary crowns intra-orally or on diagnostic models;, • Place and remove arch wires and ligature wires, • Remaining items that are within the scope of Registered Dental assistant., • Maintaining public area appearance, • Performs miscellaneous job-related duties as assignedQualifications, • High School diploma or GED required, • Easily able to learn new technologies and systems required and demonstrates a desire to learn, • Applicable licensing required for the state in which you will work: Dental Radiologic Technologist (DRT) license or willing to pursue licensure immediately required., • Certified Dental Assistant certificate preferred, • Registered Dental Assistant License preferred, • 1+ years work experience as a Dental Assistant preferred, • Ability to work in a fast-paced environment, • Requires some flexibility in scheduling, such as the ability to work evenings and weekends as needed, • X-ray License required, • Current NJ Registered Dental Assistant license, • Active CPR Certification is required.Knowledge and Skills/Expected Competencies, • Knowledge of dental instruments and patient care., • Ability to clearly communicate medical information to professional practitioners and/or the general public., • Excellent organization, prioritization, follow up, analytical and time management skills with ability to handle multiple priorities and deadlines. Benefits Summary At ProSmile, we are committed to supporting the health and well-being of our employees and their families. We offer the following benefits for Full Time Benefits Eligible Positions (35+ hours per week) and Part Time Benefits Eligible Positions (30-35 hours per week): • Medical Insurance: Choice of five comprehensive Aetna medical plans, including options with low copays, deductible-sharing, and national provider networks., • Dental Insurance: MetLife plans offering preventative, basic, major, and orthodontic coverage options., • Vision Insurance: Davis and UHC vision plans with annual exams, eyewear allowances, and contact lens benefits., • Flexible Spending & Health Savings Accounts: Pre-tax savings accounts for medical, dependent care, and healthcare expenses., • Life & Disability Insurance: Employer-paid basic life and AD&D insurance, with voluntary life, short-term, and long-term disability plans., • Additional Perks:, • Employee Assistance Program (EAP), • Identity Theft & Fraud Protection, • Legal Support Services, • Discount Programs (including pet insurance, travel, theme parks, electronics, etc.), • Wellness Programs, • Financial Wellness and Planning Tools, • Eligible Dental Assistant team members may also have access to company-supported reimbursement for certain licenses and certifications, subject to role eligibility and company guidelines. Physical/Mental Demands and Work Environment The physical demands described are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand, walk and use hands and arms to operate general office equipment (PC, telephone, file cabinets, copier, fax machine and printer). The employee may occasionally lift and/or move between 10 and 25 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus. The employee may need to travel to healthcare practices. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The noise level in the work environment is usually low to moderate. The Company reserves the right to modify the job description based upon its needs and may require the employee to perform functions beyond those mentioned above. Neither this job description nor any other communication creates an employment contract between the Company and the employee. Equal Employment Our culture encourages individual development, embraces an inclusive environment, rewards innovative excellence, and leads in provider and patient satisfaction. Prosmile values diversity, inclusion, and equity as matters of fairness and effectiveness. We are committed to hiring and retaining a staff that reflects the diversity of the communities we serve, fostering an inclusive working environment where staff of all backgrounds feel welcomed and engaged. ProSmile is an Equal Opportunity Employer and encourages applications from individuals underrepresented in the medical sector, including people of color, and persons with non-traditional work and educational experience. All who believe they meet the stated qualifications are invited to apply. Company Safety We believe that the best care for our patients starts with the best care for our employees. ProSmile is committed to proactively creating and maintaining an environment that is safe for our team and patients. Employees are required to wear Personal Protective Equipment (PPE) including face masks, gloves, gowns, and more as needed and in accordance with CDC standards. Powered by JazzHR f2koTNVV3D

Job DescriptionCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description The Medical Affairs organization provides patients, healthcare providers, and payers everywhere with the practical and clinically relevant information and solutions they need to use AbbVie products safely and effectively, throughout the product lifecycle and the patient’s journey. The Scientific / Medical Director, Medical Affairs provides specialist medical and scientific input into core strategic and operational medical affairs activities for AbbVie’s Oncology portfolio such as: health-care professional and provider interactions; generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives, scientific communications, value propositioning, and safeguarding patient safety (risk minimization activities and safety surveillance activities). The Scientific / Medical Director works closely with commercial and research and development teams to provide critical medical input into evolving core medical, brand (product), and value and access strategies to support our evolving on-market and therapeutic area needs. Responsibilities • In collaboration with Global Medical teams, Clinical Development, Commercial, Market Access, Regulatory, HEOR and other functional areas, provides leadership and support for assigned indications/projects., • Works closely with Brand Teams and relevant cross-functional, area/affiliate medical teams, to provide strategic input into core asset strategy, and is responsible for executing medical support/launch activities for gynecologic oncology initiatives., • Conducts promotional review and assists in the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia., • Serves as Medical expert for internal and external stakeholders regarding asset clinical profile, value, and appropriates; and provides Medical review for cross-functional deliverables, ensuring compliance and scientific accuracy., • Develops innovative research concepts, generates evidence, and drives execution of scientific communication plans, including high-quality publications, presentations, and educational programs., • Engages and cultivates relationships with key opinion leaders, scientific advisors, and advocacy groups within the gynecologic oncology community., • Monitors the evolving relevant therapeutic landscape to inform business decisions and anticipate future needs., • Leads the development and execution of advisory boards., • May lead delivery of medical functional plan, brand plan, and/or integrated evidence plan.Qualifications Position will be commensurate with education and experience. For Scientific Director: • Advanced Degree PhD or PharmD. Additional post doctorate experience highly preferred., • 7-10 years of experience in Medical Affairs with Global Medical Affairs experience highly preferred., • Substantial understanding of relevant therapeutic area required., • Minimum of 4 years of clinical trials direct management experience in the pharmaceutical industry or academia or equivalent. 4+ years of experience is preferred. For Medical Director: • Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D). Relevant therapeutic specialty in an academic or hospital environment preferred. Completion of residency and/or fellowship is preferred., • Minimum of 2 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent. 5 years of experience is preferred. Other • Knowledge of clinical trial methodology, data analysis and interpretation, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols., • Ability to run a clinical study independently with little supervision., • Proven strategic leadership, influencing, and collaboration skills in cross-functional environments. Ability to interact externally and internally to support global business strategy., • Expertise in evidence generation, scientific communication, and health economics/outcomes research., • Must possess excellent presentation, organizational, and written/oral communication skills. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this postingbased on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more orless than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paidand may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html

Job DescriptionABOUT VITALIEF Vitalief is a trusted partner to Sponsors, CROs, and Sites across the research and clinical trials landscape. By blending deep subject matter expertise with strong business acumen, we deliver Consulting and Functional Service Provider (FSP) solutions that empower organizations to do more with less, streamlining operations, reducing costs, and accelerating breakthroughs that ultimately benefit patients. POSITION OVERVIEW We are seeking a highly experienced, strategic yet hands-on Clinical Research Operations Leader to join our delivery team as a full-time, fully benefited employee. In this role, you will partner with a multi-location community hospital system to transform its research enterprise into a scalable, high-performing, world-class clinical research operation. As the primary subject matter expert (SME), this leader will collaborate closely with the Vitalief delivery team to design and implement enterprise-level operational initiatives, with a strong emphasis on Non-Oncology programs and enhancing cross-system communication and coordination. A central focus of the role will be leading the operational build-out and execution of a Cardiovascular clinical trials pilot, including infrastructure development, staffing strategy, workflow optimization, and technology deployment. WHY VITALIEF? • Professional Growth: Join a team of experienced practitioners who bring both business acumen and domain expertise., • Impactful Work: Contribute to scientific advancements that directly improve patient lives., • People-First Culture: Thrive in an environment that fosters growth, innovation, and collaboration., • Comprehensive Benefits: Enjoy 20 PTO days, 9 paid holidays, company-paid life insurance, short- and long-term disability, a 401(k) retirement plan, and robust healthcare options., • Flexible Work Location: Hybrid role with 2–3 days per week onsite in the Orange, NJ area., • Competitive Compensation: Base salary, performance bonus, and equity incentives. KEY RESPONSIBILITIES - What Success Looks Like: • Successful design, launch and operational stabilization of a scalable Cardiovascular research pilot across multiple hospital campuses and ambulatory sites., • Aligned research strategy with institutional priorities through close partnership with executive, clinical, and administrative leadership., • Established standardized workflows, SOPs and enterprise-wide performance metrics for research operations., • Strengthened investigator engagement and increased research participation across service lines., • Established scalable infrastructure and service line activation frameworks, in collaboration with investigators and sponsors, to reduce study activation timelines, enhance start-up predictability, and support sustainable research growth., • Successfully managed cross-functional initiatives within matrixed reporting environments and complex academic-clinical governance structures., • Transition from opportunistic research conduct to a deliberate, strategic, and scalable clinical research enterprise. QUALIFICATIONS • Bachelor’s degree required; Master’s degree in Clinical Research Administration, Public Health, Nursing, or related field strongly preferred., • Minimum of 7 to 10 years of progressive clinical research operations experience, including 3 to 5 years in leadership or management roles., • Experience building and launching a clinical research multi-location operation from scratch, enabling timely initiation of multiple studies across diverse therapeutic areas., • Demonstrated experience leading and supporting complex multi-site clinical research settings, including academic medical centers, affiliated and non-academic health systems, and disparate research locations., • Demonstrated experience managing complex drug, device, adaptive, or multi-arm trials., • Cardiovascular clinical research experience strongly preferred., • Expertise in study start-up optimization, IRB processes, and regulatory compliance., • Experience with CTMS platforms (e.g., OnCore) and Epic research integration., • Strong knowledge of research billing compliance and Medicare clinical trial requirements., • Proven ability to develop SOPs, quality systems, and performance dashboards., • Experience strong relationships with sponsors and CRO partners to enhance site reputation and repeat business opportunities., • Strong executive presence with the ability to influence across matrixed environments., • Demonstrated success leading operational transformation or research program development initiatives. PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 20lbs. IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis. #LI-DNP Powered by JazzHR r6vZMkintD

Job Description Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is an award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research. Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn. Roles and Responsibilities • Lead complex projects, programs and submissions, manages client meetings, CRMs, collaborates well with regulatory, PMs and sponsors., • Can develop SAPs and iSAPs text and shells with no supervision., • Produce and present external company presentations providing industry visibility for the organization; Continually suggesting solutions to solve issues in tune with organizational direction., • Can review or develop ADAM specifications; can work with programmers and junior statisticians to resolve comments., • High technical level, Subject Matter Expert in biostatistics; willing to guide others in a variety of biostatistical techniques., • Has the ability to apply drug development knowledge during production of complex statistical analyses., • Review or create the statistical section(s) of a Sponsor’s protocol and ensure that the appropriate statistical methods are proposed for the study design and objectives. Provide valuable feedback to the Sponsor on the statistical aspects of the study., • Prepare and review statistical methods and results sections for the CSR independently in collaboration with in-house medical writers., • Demonstrate an understanding of project management-related tasks such as timelines, scope and resource requirement estimation/management., • Perform sample size calculations for a variety of scenarios and study designs. Can provide statistical consulting support to sponsors re study design and sample size calculations., • Ability to create randomization and kit schedules independently, collaborate with sponsor, randomization and drug supply management teams., • Understand the various tools that we work with and able to use them correctly (for SCM: checks in/out; use of external SharePoint)., • Provide support to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician., • Is familiar with and stays current with the latest industry practices and updated regulatory guidelines., • Write blogs and/or white papers for posting on the company website.Requirements, • Masters in Biostatistics, Statistics discipline or related field, or related experience, PhD preferred., • Minimum of 7 years’ experience in Biostatistics, Statistics or similar field required., • Submission experience (ISS/ISE)., • Has high level knowledge of drug development as it pertains to biostatistics., • Expert knowledge of scientific principles and concepts., • Good communication skills and willingness to work with others to clearly understand needs and solve problems., • Good organizational skills., • High proficiency with MS Office applications., • Hands-on experience with clinical trial and pharmaceutical development preferred., • Excellent problem-solving skills., • Familiarity with current ISO 9001 and ISO 27001 standards preferred., • Familiarity with 21 CFR Part 11, FDA, and GCP requirements., • Good understanding of CROs and scientific & clinical data/terminology, & the drug development process. Powered by JazzHR JwI5EB7jHW

Job DescriptionAbout Dyania Health Dyania Health is a venture-backed company founded in 2019 which has developed Synapsis AI, an end-to-end system that combines a medically post-trained LLM with a physician-driven algorithmic reasoning engine to understand and assess clinical characteristics in electronic medical records. Synapsis AI is designed for installation within the healthcare system's computing environment or on healthcare system private clouds to automate manual chart review of EMRs without removing any data from the healthcare system. Synapsis AI completes pre-screening on both unstructured and structured patient data, deploying medical logic with temporal sensitivity to dynamically match changing patient characteristics to complex clinical trial criteria within the exact window when a given EMR may qualify for study protocol criteria. The Role We are seeking a Staff or Senior Staff Research Scientist to lead the design, development, and implementation of advanced AI/ML and LLM-based models for clinical data understanding. This is a senior, hands-on research role. You will build and customize models, design architectures, and drive ML innovation from concept through production. This is not a data science or analytics role—we are looking for someone who deeply understands how models work internally and can independently solve complex, open-ended problems. Leveling is based on experience: • Staff Research Scientist: 7+ years of relevant experience, • Senior Staff Research Scientist: 10+ years, including technical leadership responsibilities What We’re Looking For • A senior researcher who builds models, not dashboards, • A hands-on technologist who understands model architecture, training, and optimization, • Someone who can define strategy, lead initiatives, and still write production-quality code, • A strong independent problem solver comfortable with ambiguity and research-driven development, • A technical leader who can mentor others while delivering individually Key ResponsibilitiesResearch, Development & Implementation • Design, build, train, and deploy AI/ML and LLM-based models, • Own the full model lifecycle: problem definition, research, prototyping, training, evaluation, and deployment, • Apply strong understanding of ML and AI fundamentals to real-world biomedical problems, • Develop and optimize models using Python and modern ML frameworks, • Research emerging techniques and propose innovative solutions aligned with product and business needs Problem Solving & Strategy, • Independently analyze complex, ambiguous problems and determine appropriate modeling approaches, • Evaluate and recommend technical solutions and system architectures, • Translate research concepts into scalable, production-ready systems, • Contribute to long-term ML and AI strategy and technical vision Leadership, • Lead cross-project research and development initiatives, • Provide technical mentorship and guidance to junior researchers and engineers, • Establish best practices for experimentation, model development, and deployment, • Influence technical roadmaps and architectural decisions Requirements Required Qualifications • 7+ years (Staff) or 10+ years (Senior Staff) of experience in AI/ML research or ML engineering, • Graduate degree in Computer Science, Engineering, or a related technical field, • Strong hands-on experience building, training, and deploying ML and AI models, including LLMs, • Deep understanding of model fundamentals and architecture design, • Proven ability to solve problems end-to-end, from research through implementation, • Advanced proficiency in Python for model development and training, • Experience customizing models rather than relying solely on pre-built solutions, • Ability to independently research, evaluate, and propose technical approaches Preferred Qualifications • Publication record in top-tier AI, NLP, or ML conferences, • Experience working with EMR or other complex clinical datasets, • Experience with multi-modal AI systems, • Prior senior or lead-level technical experience, • Familiarity with regulatory considerations for clinical AI systems, • Experience contributing to long-term technical strategy or system architecture, • PhD is welcome but not required Team Culture: • We lead with empathy for patients and our teammates, • We value small egos, self-awareness, and humility in our teammates, • We appreciate flexible and adaptive attitudes towards solving problems, as strategic priorities may shift, • We love diversity of thought, perspective, working style, skill set, knowledge, and interests amongst our team, • We value open dialogue and brainstorming across multidisciplinary teams Dyania Health is an equal opportunity employer that is committed to workplace diversity and inclusion. We do not discriminate on the basis of race, gender, gender identity, color, religion, national origin, sexual orientation, or any other legally protected characteristic as outlined by federal, state, or local laws. Benefits • Competitive Salary, • Health Care Plan (Medical, Dental & Vision), • Retirement Plan (401k, IRA), • Generous Paid Time Off (Vacation, Sick & Public Holidays), • Family Leave (Maternity, Paternity), • Training & Professional Development Support, • Remote work

Job DescriptionSummary: The Clinical Research Assistant will assist the Clinical Research Coordinator and the Principal Investigator with administering activities to facilitate clinical research, which may include working with an affiliate or collaborating research sites. Exercises judgment within the allowable limits defined within clinical trials protocols, standard operating procedures, and under the direction from the study Investigator and supervisor. Always maintains subject and document confidentiality, understands and complies with the appropriate sponsor requirements, regulations including the Food and Drug Administration (FDA), good clinical practice (GCP), International Conference on Harmonization (ICH), Health Insurance Portability and Accountability Act (HIPAA), Institutional Review Boards (IRB), and institutional policies and procedures by performing the following duties.Duties and Responsibilities: • Assists with the creation and completion of study related documents and new study preparation., • Assists with the completion of regulatory submissions and maintains regulatory files as directed., • Acts as a secondary liaison with sponsors., • Assists with the preparation for study monitor visits as directed., • Completes case report forms as directed., • Creates reports as requested., • Completes study directed assessments with patients to include, but not limited to adverse events, test article (TA) handling, appointment scheduling, records review, treatment coordination, collecting vital signs, and subject health assessment., • Assists with subject screening and recruitment as directed., • Updates Clinical Trial Management Software (CTMS) as directed., • Coordinates multiple projects with competing priorities and deadlines, as needed based on clinical trial protocol directives and study volume., • Interacts with internal and external personnel to include, but not limited to physicians, nurses, administration staff, industry sponsor representatives, central laboratory/imaging personnel, and clinical trial patients.Education/Experience:High school diploma or general education degree (GED); or two to four years related experience and/or training; or equivalent combination of education and experience.Certificates and Licenses:, • Clinical research certification preferredKnowledge, Skills, and Other Abilities:, • Ability to demonstrate competence in oral and written communication, • Bilingual (English/Spanish) preferred, • Must be organized, attentive to detail, and possess a positive, friendly, and professional demeanor, • Must be flexible with changing priorities and able to communicate in a diplomatic and professional manner, • Medical knowledge, including medical terminology, • Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of the organization., • Must have knowledge of Microsoft Office Word, Microsoft Excel, Internet Explorer, Google Chrome, Mozilla Firefox, web-based enterprise solutions, and Electronic Case Report Form systems.Work Environment and Physical Demands:The work environment and physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions., • Work is performed in an office/laboratory and/or a clinical environment., • Exposure to biological fluids and/or bloodborne pathogens., • Personal protective equipment required such as protective eyewear, garments, and gloves., • Occasional travel may be required domestic and/or international., • Ability to work in an upright and/or stationary position for 6-10 hours per day., • Frequent mobility required., • Occasional squatting, kneeling, or bending., • Light to moderate lifting and carrying (or otherwise moves) objects including medical equipment with a maximum lift of 20-50 lbs.Perks of working at Summit Pinnacle Clinical Research:, • 401k, • Medical, dental, vision, long term disability, short term disability, FSA, and life insurance, • 3 weeks of paid time off, • 14 paid company holidays, • Scrub voucher (specific positions apply), • And more!Summit Pinnacle Clinical Research is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, disability, gender, national origin, age, genetic information, military or veteran status, sexual orientation, gender identity, marital status or any other protected Federal, State/Province or Local status unrelated to the performance of the work involved.

Job Description Clinical Trial Recruiter RCT 101/100 Job Type: Full Time and Part Time positions available Seeking individuals for Clinical Trials Recruiter position in our Fairfield, NJ facility. CPTC provides testing and consultation services to the pharmaceutical, cosmetic, personal care, medical device and household product industries. Job Type: Full Time/Part Time: Base Hours vary MINIMUM QUALIFICATION REQUIREMENTS To perform this job, an individual must be able to perform each essential duty satisfactorily, and meet the educational and experience requirements. ESSENTIAL DUTIES AND RESPONSIBILITIES • Review database for panelists with matching inclusion/exclusion criteria to upcoming clinical trial protocols., • Contact potential subjects and discuss clinical trial requirements and availability to participate, • Ensure compliance with protocols, and standard operating procedures, • Data entry of subject data into database, • Provide assistance to clinical and photobiology departments as needed EDUCATION and/or EXPERIENCE · High School diploma / GED required · General Office Equipment Skills · 2 years clerical experience preferred COMMUNICATION SKILLS • Evidence of a strong communication and interpersonal skills with the ability to facilitate multi-disciplinary teams. OTHER KNOWLEDGE, SKILLS and ABILITIES • Computer skills: MS Word and Excel required, • Organizational, analytic, and problem-solving skills, • Attention to detail; ability to maintain confidentiality, • Strong customer service skills necessary Applicant should possess the ability to organize and maintain all data for assigned projects and ensure adherence to established policies and procedures. PHYSICAL REQUIREMENTS On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch; talk, hear, and smell. Specific vision requirements including reading of written documents, visual inspection of documents and use of computer monitor screen frequently. This position entails repetitive motion with keyboard and mouse. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age or any other characteristic protected by law. Company DescriptionConsumer Product Testing Company is a worldwide leader in the contract laboratory testing of cosmetics, personal care, pharmaceuticals, medical devices and specialty chemicals. Since 1975, our staff has assisted clients with their testing needs from conception to completion. Our technical staff has extensive experience that is used to assist clients through each phase of the testing process. Our Quality Assurance and Regulatory staff monitors compliance to our internal SOPs and applicable regulations. We attribute our growth to our dedication to the needs of our clients. Well known for our superior customer service, we become an integral part of our clients' team, providing timely, reliable, accurate, and reproducible results.Consumer Product Testing Company is a worldwide leader in the contract laboratory testing of cosmetics, personal care, pharmaceuticals, medical devices and specialty chemicals. Since 1975, our staff has assisted clients with their testing needs from conception to completion. Our technical staff has extensive experience that is used to assist clients through each phase of the testing process. Our Quality Assurance and Regulatory staff monitors compliance to our internal SOPs and applicable regulations. We attribute our growth to our dedication to the needs of our clients. Well known for our superior customer service, we become an integral part of our clients' team, providing timely, reliable, accurate, and reproducible results.

Job DescriptionCompany Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description Clinical Site Centricity drives the collection, synthesis, and action planning around site feedback and the strategic infrastructure that contributes to strengthening the partnership between AbbVie and our clinical trial sites. The Associate Director, Site Enablement sits within the Clinical Development Operations (CDO) organization. This role will report into the Director, Clinical Site Centricity. We can hire for this role at our Irvine, CA; South SF, CA; North Chicago, IL; Florham Park, NJ; and Branchburg, NJ locations. • Lead the development of a site enablement strategy including but not limited to emerging research site engagement and training, • Work closely with business owners to proactively identify opportunities and support ongoing enhancements to the overall site experience., • Conduct industry assessments for best in class solutions for sponsors to support clinical trial sites, • Coordinate with stakeholders from all relevant departments to bring site insights into the development of customized, sponsor-backed site solutions, • Lead project management and implementation of site facing solutions, where appropriate, including implementation planning, assessment of ROI and change management, • Develop and manage external-facing materials to promote and communicate site enablement offerings to stakeholders., • In collaboration with partners, facilitate the development of integrated communication channels with clinical sites and establish communications best practices. Create customer-centric communications content and talking points to clearly describe topics related to AbbVie clinical operations to sites, • Assess and select appropriate training vendors to meet the needs of emerging research sites or to support site solutions, • Support Country Study Management (CSM) leaders in the coordination and execution of training cohorts for emerging research sites, to ensure consistent implementation and quality standards., • Define key performance indicators (KPIs) and other program metrics; implement processes to measure and report program effectiveness, ensuring continuous improvement., • Ensure site enablement capabilities, training methods, and communications are compliant with all procedures and regulationsQualifications, • Bachelor’s Degree required, 8-10+ years of Clinical Operations, Communications, Strategy and/or Management Consulting experience., • High level of familiarity with clinical drug development process, • Robust understanding of clinical site management activities (e.g., clinical site monitoring, site management), monitoring, and GxP regulations, • Ability to communicate clearly and effectively with stakeholders at all levels of the organization and collaborative style., • Excellent written communication skills with experience developing scientific or health-related communications content and ability to assimilate and synthesize key themes from qualitative and quantitative data, • Confidence to lead structured meetings and presentations including data-driven insights, comfortable with qualitative and quantitative data including basic statistical analyses. Strong analytical skills with experience utilizing business analytics or KPIs for decision-making and driving improvements., • Demonstrated ability to prioritize with minimal direction. Ability to multitask and independently lead projects and meet key deadlines. Demonstrated Project Management capabilities, experience in process improvement, operational excellence, and change management., • Strong leader – who can coach and develop direct reports as well as influence without authority, Demonstrates ability to work effectively in a cross-functional team and navigate a matrixed organization, • Ability to adopt a customer centric mindset and understand diverse perspectives, • Demonstrates innovative mindset and openness to new ideas, feedback, and technologies, • Detail oriented with attention to quality Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our long-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html

Job DescriptionCompany Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description Leads the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs. Participates in and may lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data supporting overall product scientific and business strategy. Responsibilities • Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel, and AbbVie study staff., • Has overall responsibility for leading clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for ensuring agreed-upon study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned., • Primary responsibility for and ownership of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents., • May oversee the work of Medical and/or Scientific Directors and of Clinical Scientists working on the same or related programs., • May serve on or chair Clinical Strategy Team(s), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In the role of CST Chair, responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to Asset Development Teams (ADTs) and ADT Leadership Boards (ALBs)., • Serves as an in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific and medical activities with internal stakeholders as they relate to ongoing projects. May participate in or lead clinical development contributions to due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies., • Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate., • Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. May represent AbbVie at key external meetings., • Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions., • Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.Qualifications, • Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable., • At least 5 years (7 years preferred) of clinical trial experience in the pharmaceutical industry, academia, or equivalent., • Ability to run a complex clinical research program independently., • Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead through influence., • Ability to interact externally and internally to support a global scientific and business strategy., • Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols., • Must possess excellent oral and written English communication skills., • Ability to exercise judgment and address complex problems and create solutions for one or more projects. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of thisposting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location,and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our long-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless anduntil paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html

Job Description About Hand Over Hand LLC At Hand Over Hand, we believe every child deserves the opportunity to thrive. As a leading provider of Applied Behavior Analysis (ABA) therapy, we partner with families to empower children with autism and developmental disabilities. Our work is deeply mission-driven: we’re here to make a difference in the lives of children and their communities. Our culture is collaborative, supportive, and purpose-filled. We celebrate growth of our team, of our families, and of ourselves. If you’re passionate about early childhood development and want to do meaningful, hands-on work that truly changes lives, you’ll feel right at home here. Why This Role Matters This isn’t just another clinical role, it’s an opportunity to be a steady, positive presence in a child’s everyday world. As a Behavior Technician, you’ll work directly with children in childcare centers, homes, and community settings, helping them build communication, social, behavioral, and adaptive skills that support independence and inclusion. Under the guidance of a Board Certified Behavior Analyst (BCBA), you’ll bring individualized treatment plans to life in natural, play-based environments, helping children succeed during real routines, peer interactions, and daily activities.. How You’ll Make an Impact • Support children where they learn and play: Deliver one-on-one and small-group ABA services in childcare and community-based settings., • Build meaningful skills: Help children develop communication, social interaction, emotional regulation, and daily living skills., • Promote inclusion: Embed learning opportunities into play, routines, and peer interactions in natural environments., • Ensure consistency and safety: Collaborate with childcare staff, families, and clinical leadership to provide high-quality, ethical care., • Grow professionally: Receive ongoing training, supervision, and feedback to strengthen your clinical skills and confidence. What You’ll Own & Elevate • Implement individualized ABA treatment plans designed by the supervising BCBA., • Use evidence-based strategies such as natural environment teaching (NET), discrete trial training (DTT), prompting, and reinforcement., • Collect accurate data on skill acquisition and behavior goals during sessions., • Document session notes and progress updates in a timely, compliant manner., • Communicate observations and progress with supervisors and team members., • Participate in supervision, team meetings, and required trainings., • Maintain confidentiality and uphold ethical and professional standards at all times. Who You Are • Compassionate, patient, and energized by working with young children., • Comfortable in active, fast-paced environments like childcare centers and community settings., • Open to coaching and eager to learn, grow, and refine your skills., • A reliable team player who values collaboration, consistency, and follow-through., • Mission-driven and motivated to make a real difference in children’s lives. What You Bring • High school diploma or equivalent (required)., • Willingness to obtain Registered Behavior Technician (RBT) certification within the first 120 days of employment (required)., • Experience working with children with autism or developmental disabilities (preferred)., • Experience in childcare, preschool, or school-based settings (strongly preferred)., • Ability to pass background checks, clearances, and health screenings required by state regulations and childcare centers. Why You’ll Love Working Here • Competitive Salary (with OT Eligibility): Based on experience and location., • Comprehensive benefits package: Medical, dental, vision, 401(k), PTO, sick time, and more, • Supportive clinical supervision: Ongoing guidance from experienced BCBAs., • Professional development: Paid training, supervision, and opportunities for growth., • Meaningful work: Everything you do helps children gain skills that last a lifetime., • Collaborative culture: Work alongside passionate clinicians who value teamwork and compassion., • Purpose & pride: Be part of a team that celebrates progress, big and small, every single day. Ready to make a hands-on difference in a child’s life? Apply today and join Hand Over Hand LLC to help children learn, grow, and thrive; one meaningful moment at a time. Hand Over Hand LLC is an EEO Employer: All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, sex, religious creed, disability, or any other category protected under law. Monday - Friday | 7:30 AM to 4:00 PM

Job Description About MMS Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research. Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn. Senior Biostatistician: Responsibilities: • Create randomization and kit schedules independently, collaborate with sponsor, randomization and drug supply management teams., • Develop phase 1-4 SAPs and make significant contributions to iSAPs. Create SAP TLFs shells for all phases and studies., • Review ADAM and TLFs; work with client and programmers to resolve comments., • Strong programming and logic skills (working knowledge of SAS), • Ability to apply drug development knowledge during production of high quality statistical analyses., • Perform sample size calculations for a variety of scenarios and study designs., • Leads projects (all phases and even a program of studies) and smaller submissions, manages client meetings, CRMs, collaborates well with regulatory, PMs and sponsor., • Strong knowledge of CDISC (especially SDTM and ADaM), looks to understand guidance from FDA from the different therapeutical areas., • Understand the various tools that we work with, • High level knowledge of drug development as it pertains to biostatistics., • Provides support to Data Safety Monitoring Boards (DSMB) by preparing and presenting output as the unblinded statistician., • Review the statistical section of a Sponsor’s protocol and ensure that the appropriate statistical methods are proposed for the study design and objectives. Provide valuable feedback to the Sponsor on the statistical aspects of the study. Create the statistical section of the Sponsor’s protocol with minimal support, • High proficiency with MS Office applications, • Demonstrate an understanding of project management-related tasks such as timelines, scope and resource requirement estimation., • Provide ICH guideline based input as applicable to statistics., • Prepare and review statistical methods and results sections for the CSR with minimal support in collaboration with in-house medical writers.Requirements:, • College graduate in Biostatistics, Statistics, or Mathematics discipline or related field, masters or PhD preferred, or many years of related experience required., • Minimum of 5 years’ experience in Biostatistics or similar field required., • Expert knowledge of scientific principles and concepts., • Has high level knowledge of drug development as it pertains to biostatistics; has the ability to apply drug development knowledge during production of high quality statistical analyses., • Strong SAS programming, SAS base, SAS macro experience., • Thorough knowledge and understanding of clinical data preferred., • Strong experience with data and production of TLGs., • Excellent scientific writing skills., • Strong resource for biostatistics; willing to guide others in a variety of biostatistical techniques., • Proficiency with MS Office applications., • Hands-on experience with clinical trial and pharmaceutical development preferred., • Good communication skills and willingness to work with others to clearly understand needs and solve problems., • Excellent problem-solving skills., • Good organizational and communication skills., • Familiarity with 21 CFR Part 11, FDA, and GCP requirements., • Basic understanding of CROs and scientific & clinical data/terminology, & the drug development process. Please consider your application unsuccessful if we do not reach out to you within 14 days of your submission. Powered by JazzHR vG51XmhQd9

Job DescriptionABOUT VITALIEF Vitalief is a trusted partner to Sponsors, CROs, and Sites across the research and clinical trials landscape. By blending deep subject matter expertise with strong business acumen, we deliver Consulting and Functional Service Provider (FSP) solutions that empower organizations to do more with less, streamlining operations, reducing costs, and accelerating breakthroughs that ultimately benefit patients. POSITION OVERVIEW We are seeking a highly experienced, strategic yet hands-on Clinical Research Operations Leader to join our delivery team as a full-time, fully benefited employee. In this role, you will partner with a multi-location community hospital system to transform its research enterprise into a scalable, high-performing, world-class clinical research operation. As the primary subject matter expert (SME), this leader will collaborate closely with the Vitalief delivery team to design and implement enterprise-level operational initiatives, with a strong emphasis on Non-Oncology programs and enhancing cross-system communication and coordination. A central focus of the role will be leading the operational build-out and execution of a Cardiovascular clinical trials pilot, including infrastructure development, staffing strategy, workflow optimization, and technology deployment. WHY VITALIEF? • Professional Growth: Join a team of experienced practitioners who bring both business acumen and domain expertise., • Impactful Work: Contribute to scientific advancements that directly improve patient lives., • People-First Culture: Thrive in an environment that fosters growth, innovation, and collaboration., • Comprehensive Benefits: Enjoy 20 PTO days, 9 paid holidays, company-paid life insurance, short- and long-term disability, a 401(k) retirement plan, and robust healthcare options., • Flexible Work Location: Hybrid role with 2–3 days per week onsite in the Orange, NJ area., • Competitive Compensation: Base salary, performance bonus, and equity incentives. KEY RESPONSIBILITIES - What Success Looks Like: • Successful design, launch and operational stabilization of a scalable Cardiovascular research pilot across multiple hospital campuses and ambulatory sites., • Aligned research strategy with institutional priorities through close partnership with executive, clinical, and administrative leadership., • Established standardized workflows, SOPs and enterprise-wide performance metrics for research operations., • Strengthened investigator engagement and increased research participation across service lines., • Established scalable infrastructure and service line activation frameworks, in collaboration with investigators and sponsors, to reduce study activation timelines, enhance start-up predictability, and support sustainable research growth., • Successfully managed cross-functional initiatives within matrixed reporting environments and complex academic-clinical governance structures., • Transition from opportunistic research conduct to a deliberate, strategic, and scalable clinical research enterprise. QUALIFICATIONS • Bachelor’s degree required; Master’s degree in Clinical Research Administration, Public Health, Nursing, or related field strongly preferred., • Minimum of 7 to 10 years of progressive clinical research operations experience, including 3 to 5 years in leadership or management roles., • Experience building and launching a clinical research multi-location operation from scratch, enabling timely initiation of multiple studies across diverse therapeutic areas., • Demonstrated experience leading and supporting complex multi-site clinical research settings, including academic medical centers, affiliated and non-academic health systems, and disparate research locations., • Demonstrated experience managing complex drug, device, adaptive, or multi-arm trials., • Cardiovascular clinical research experience strongly preferred., • Expertise in study start-up optimization, IRB processes, and regulatory compliance., • Experience with CTMS platforms (e.g., OnCore) and Epic research integration., • Strong knowledge of research billing compliance and Medicare clinical trial requirements., • Proven ability to develop SOPs, quality systems, and performance dashboards., • Experience strong relationships with sponsors and CRO partners to enhance site reputation and repeat business opportunities., • Strong executive presence with the ability to influence across matrixed environments., • Demonstrated success leading operational transformation or research program development initiatives. PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 20lbs. IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis. Powered by JazzHR tM42k6zqBG

Job DescriptionCompany Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description The Medical Affairs organization provides patients, healthcare providers, and payers everywhere with the practical and clinically relevant information and solutions they need to use AbbVie products safely and effectively, throughout the product lifecycle and the patient’s journey. The Scientific Director / Senior Medical Director, Medical Affairs - Global Oncology Pipeline provides medical and scientific input into core strategic and operational pipeline medical affairs activities for the lung cancer portfolio such as: health-care professional and provider interactions; generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, scientific communications, and value proposition) and safeguarding patient safety (risk minimization activities and safety surveillance activities). Works closely with sales, marketing, and commercial teams to provide strategic medical input into core brand (product) strategies, and to support medical affairs, marketing activities (promotional material generation and product launches) and market access. This position can be based at our Mettawa, IL, Florham Park, NJ, or South San Francisco, CA locations and will follow a hybrid schedule of Tuesdays-Thursdays in office. Responsibilities • Leads medical input into disease area strategy and asset strategies within the lung cancer oncology pipeline portfolio., • Leads pipeline medical evidence generation strategy and execution including company sponsored studies, research collaborations and investigator initiated studies., • Provides in-house medical expertise for the disease area and assets, coordinating appropriate scientific activities with internal and external stakeholders as they relate to ongoing programs. May participate in due diligence or other business development activity as required by program needs, and contribute to translational strategy in partnership with discovery colleagues., • Acts as a medical interface and actively solicits insights and opinion through the development and execution of medical expert engagement strategies, partnering with clinical development, commercial, access, area and affiliate colleagues to ensure that broad perspectives both internally and externally are incorporated into strategies and plans as appropriate., • Leads creation of early scientific narratives, messaging, and communications activities including congress planning, medical education, publication strategies and plans., • May assist in the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia. Assists with the scientific review, development, approval, execution, and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities., • May interact with and coordinates appropriate scientific and medical activities with internal stakeholders (i.e., commercial, clinical operations, discovery, statistics, regulatory, etc…) as they relate to on-going medical affairs projects. Serves as the scientific team interface for key regulatory discussions., • Provide scientific/medical education to investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information. Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource., • Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities.Qualifications Scientific Director Qualifications: • Advanced Degree PhD or PharmD. Additional post doctorate experience highly preferred., • Typically, 10-15 years of experience in the pharmaceutical industry or equivalent, • 7-10 years of experience in Medical Affairs with Global Medical Affairs experience highly preferred., • Substantial knowledge of relevant therapeutic area required., • Knowledge of clinical trial methodology, data analysis and interpretation, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols., • Proven leadership skills in a cross-functional global team environment., • Must possess excellent oral and written English communication skills. Senior Medical Director Qualifications: • Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D). Relevant therapeutic specialty in an academic or hospital environment preferred. Completion of residency and/or fellowship is preferred., • Minimum of 2 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent. 3+ years of experience is preferred., • Substantial knowledge of relevant therapeutic area required., • Knowledge of clinical trial methodology, data analysis and interpretation, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols., • Proven leadership skills in a cross-functional global team environment, • Ability to interact externally and internally to support global business strategy., • Must possess excellent oral and written English communication skills. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our long-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html

Job DescriptionCompany Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description Provides support for assigned products within therapeutic area and is responsible for performing the accurate and detailed scientific review of medical content for promotional and non-promotional materials. Contributes to the creation of medical affairs externally facing and training materials in accordance with established polices and standards, including regulatory guidelines to meet customer needs. Functions in a scientific support role within assigned TA supporting on-market products. Acquires and establishes current therapeutic expertise necessary to serve as scientific, medical, and clinical to field medical teams/affiliates, TA teams, brand teams and R&D partners. Responsibilities List up to 10 main responsibilities for the job. Include information about the accountability and scope. • Identifies Insight Trends: Aids in the broader teams ability to address educational scientific gaps identified through the gathering of feedback from multiple field sources, compile and summarize to provide relevant insights., • Development of non-promotional field/affiliate resources: Develops non-promotional field/affiliate resources and ensures communications are supported by medical communication standards, pharmacovigilance standards, SOP’s and all other quality and compliance standards in Medical Affairs., • Provides input into externally facing materials for use as directed : (i.e. Congress Booth, Ad Boards, Med Ed) with HCP or EE interactions (Payer, Patients, Prescribers, and Providers); educational initiatives (medical education, data, guidelines, and value proposition), • As directed, identifies, designs and implements focused and impactful internal training programs aiming to shape scientific understanding and medical practice (e.g. for Sales Representatives, MSLs, MOSLs, Affiliates), • Promotional Material Review: Responsible for performing the accurate and detailed medical review of advertising and promotional materials for assigned therapeutic area(s) within Medical Affairs. Provides timely and accurate reviews of promotional materials in accordance with established policies and practice standards, including regulatory guidelines to meet customer needs., • Evaluate literature, interpret data, write effectively, articulate information to a variety of internal and external audiences and effectively negotiate with counterparts from cross-divisional functional areas, • Maintain understanding of product knowledge and labeling, associated disease states, relevant literature, treatment guidelines, competitor information, • Evaluate risk and elevate as appropriate within the therapeutic area to ensure materials are compliant with applicable regulatory standards across all communication channels.Qualifications, • Scientific degree; advanced degree (e.g., MS, PhD, MD/DO, PharmD, NP, MSN) preferred., • 2-3 years of clinical, scientific/research, or industry related experience or equivalent required demonstrating strong leadership competencies and proven team-building skills with ability to lead in a global matrixed environment. Understanding of relevant therapeutic area required., • Basic knowledge of clinical trial design, results and methodology, regulatory and compliance requirements governing development of promotional and non-promotional materials is desirable., • Demonstrated analytical, conceptual and administrative skills. Excellent communication skills (written and presentation)., • Flexibility and adaptability to organizational change and business priorities. Ability to work in a fast-paced corporate environment. High sense of urgency and commitment to excellence in the successful achievement of objectives., • Excellent planning and organizational skills. Ability to manage multiple priorities and demonstrate good business judgment., • Strong Project Management and Teamwork skills to address project risks and issues., • Ability to influence without direct authority to effectively deliver cross-functional projects Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our long-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html

Job Description Summary: The Quality Associate will perform independent examination (i.e., audit) of multiple trial related activities and documents, to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed, and accurately reported, according to the protocol, standard operating procedures (SOPs), GCPs and the reporting any findings to the Internal Study Team and department management (e.g., Team Manager, Study Manager, Director, etc.). The Quality Associate is responsible for building and maintaining effective working relationships with internal staff/external vendors. The ideal candidate will be responsive, thoughtful, self-motivated, highly organized, and a team-player. This role reports directly to the VP of Compliance. Under supervision of a mentor/coach, the Quality Associate will be responsible for: Duties and Responsibilities: Quality Duties: • Responsible for quality control checks on study documents related to the conduct of the clinical trial in different therapeutic areas and phases, • Audits phases of laboratory and clinical studies, reports, and performs related duties (e.g., issues findings and QA statements), • Will also support training for site staff, this include creating and presenting quality content., • Audits all disciplines (examples of disciplines include Screening, Recruiting, Clinical Operations, Laboratory, Data Services), • Assist with writing QA audit or QC reports, • Works with internal clinical research team to ensure that inspection findings are clearly communicated and understood, • Evaluates inspection finding responses to ensure they are written to address the findings appropriately, • Ensures through phase and data inspections that the SOPs, which are involved in the conduct of a study, are current and practiced, • Introduction to in-life audits, process audits, and vendor audits, • Identifies and communicates opportunities for process improvement based on audit and inspection observations, • Maintains necessary documentation of QA records and study files, • Notifies management of observed quality and compliance trends in the areas inspected, • Interprets GCP, and associated regulatory documents to facilitate auditing and process improvement recommendations, • Carries out appropriate self-development efforts as directed, • Performs other related duties as assigned Regulatory Duties: • Ensures that the research site follows standard operating procedures, sponsor/CRO requirements, Food and Drug Administration (FDA) regulations, ICH guidelines, and good clinical practices pertaining to theconduct of clinical pharmaceutical and device protocols, • Maintains subject and document confidentiality, understands, and complies with the appropriate sponsor requirements, regulations including the Food and Drug Administration, good clinical practice (GCP), International Conference on Harmonization (ICH), Health Insurance Portability and Accountability Act (HIPAA), Institutional Review Boards (IRB), and institutional policies and procedures, • Works under limited supervision to assure compliance with federal regulations relating to human subject research, • Understands and applies ethical principles and multiple regulations to clinical research protocols, • Review study protocols, informed consent documents, and other study-related documentation, to assure conformance with all applicable requirements, • Prepares, maintains, and provides oversight to all research-related regulatory documents, • Populates and coordinates the entire process of initial regulatory documents' submission to the IRB, sponsors, and state or federal regulatory offices as necessary, • Compiles study information and submits initial, continuing, and final reports to the IRB and/or sponsor, • Prepares applicable submission forms and submits updated documents, including but not limited to amendments, addendums, investigator's brochures, safety information, form FDA 1572s, and informed consent documents, • Accurately files and maintains all necessary logs within the regulatory binder(s), assists in and manages the archival of clinical trial documents/records, • Prepares for monitoring visits and audits, • Manages and updates employee curriculum vitas and ensures copies of all current and applicable medical licenses are on file, • Creates error free written documents and reports such as cover letters, notes-to-file, and memos, • Exercises judgement within the allowable limits defined within clinical trials protocols, standard operating procedures, and under the direction from the study Investigator and supervisor, • Interacts with internal and external personnel, including but not limited to physicians, nurses, research staff members, administration staff, industry sponsor representatives, IRBs, central laboratory/imaging personnel, and clinical trial patients and attends site initiation visits, • Coordinates multiple projects with competing priorities and deadlines, as needed based on clinical trial protocol directives and study volume, • Other duties as assigned Duties, responsibilities, and activities may change, or new ones may be assigned at any time. Qualifications: • Bachelor’s Degree in scientific area of study or equivalent combination of education, training, and experience, • Previous experience in a clinical research environment or equivalent work environment, • 2-4 years of previous experience as regulatory and/or quality associate in clinical research, • Knowledge of regulations governing clinical research (CFR, GCP, HIPAA) preferred, • Proficiency in all Microsoft Office applications (Word, Excel, Outlook, PowerPoint), • Familiarity with clinical trial management system software, preferably Clinical Research IO, • Basic medical knowledge, including medical terminology, • Demonstrated competence in oral and written communication, • Must complete CITI and GCP training certification, • Demonstrated organizational skills and outstanding time management, including keen attention to detail, • Possess impeccable integrity and personal and professional values that are consistent with PCR’s high standards and mission, • Comply with the company policies, code of ethics, and guiding values at all times Competencies: • Strong analytical and problem-solving skills, • Detail oriented with the ability to perform at a high level of accuracy, • Proactive at identifying and addressing issues in real time, • Must be flexible with changing priorities and able to communicate in a diplomatic and professional manner, • Must handle confidential matters and sensitive information with discretion and judgment, • Ability to research regulatory issues and provide recommendations for resolution, • Ability to handle multiple projects simultaneously, • Ability to manage small projects and work independently, • Ability to understand and interpret clinical research protocols and other applicable sponsor documentsWork Environment and Physical demands: The work environment and physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. • Work is performed in an office/laboratory and/or a clinical environment., • Exposure to biological fluids and/or bloodborne pathogens., • Personal protective equipment required such as protective eyewear, garments, and gloves., • Travel between two NJ sites is required, • Ability to work in an upright and/or stationary position for 6-10 hours per day., • Frequent mobility required., • Occasionally squatting, kneeling, or bending., • Light to moderate lifting and carrying (or otherwise moves) objects including medical equipment with a maximum lift of 20-50 lbs.Salary and Benefits: Summit Pinnacle Clinical Research provides each of our team members with opportunities for personal and professional growth in a team-oriented working environment. We offer competitive pay, excellent benefits, and the chance to grow professionally in the healthcare industry. The salary range for this position will be commensurate with experience. • 401k, • Medical, dental, vision, long term disability, short term disability, HSA, and life insurance, • 3 weeks of paid time off, • 14 paid company holidays, • Scrub voucher (specific positions apply), • And more! Summit Pinnacle Clinical Research is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, disability, gender, national origin, age, genetic information, military or veteran status, sexual orientation, gender identity, marital status or any other protected Federal, State/Province or Local status unrelated to the performance of the work involved.

The role entails developing and delivering coursework on Scientific Writing and Clinical Trial Protocol Development.