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Job Title: Manager, Vendor Outsourcing Location: Parsippany, NJ (HM Site); Foster City, CA; Santa Monica, CA Duration: 12 months Hybrid: Onsite 3 days a week - T/W/Th Functional Area: Development Operations, Vendor Outsourcing Position Type: Full Time Equivalent Department: Vendor Outsourcing Client is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. As part of our rapidly growing science-driven organization, colleagues at client are revolutionizing healthcare by bringing urgently needed medicines to patients in the areas of Virology, Inflammation and Oncology conditions. We are proud to have some of the most talented colleagues from across the research, healthcare, pharmaceutical, biotechnology & business sectors, working together and supporting each other to help make a real difference to the lives of patients. Client is currently seeking an industry leader for Manager, Vendor Outsourcing within our Development Business Operations department. The Manager will have the opportunity to lead sourcing and contracting for full service CRO contracts within Oncology. This position will be responsible to develop and maintain sourcing plans, as well as sourcing events and contracting in a clinical research environment. This role will be responsible for the sourcing, contracting, including, facilitating vendor selection, RFI, RFP, contracting, and qualification with a focus on CRO services outsourced in support of client clinical trials. The core responsibilities and skills required for this position include but is not limited to: Delivery Excellence • Is an expert in contract management and had a history of implementing and executing category roadmaps and sourcing plans, • Develops global clinical development vendor strategy for a program or therapeutic areas, • Manages contract and sourcing activities for clinical development programs providing consistent customer service and delivering quantitative value through cost savings and transformation/innovation, • Manages the contract negotiation process across the entire life cycle including RFI, vendor identification, RFP, vendor selection decision, contracting negotiation, performance monitoring, change orders, and ensures proper closeout of agreements to maximize contract value and achieve target savings, • Ensure the vendor selection process is compliant by managing risks, • Partners with other functions such as Compliance, Legal and Regulatory as necessary, • Collaborates with internal customers in vendor bidding and proposal development (RFP creation and analysis), • Partners with internal customers to develop study specifications and leverages benchmarking tools as appropriate, • Translates business requirements into vendor capabilities and develops recommendations for vendor selection for a program or therapeutic area, • Is an SME in resolving complex issues relating to contract negotiation and management?, • Oversees the identification, selection and management of global external service providers, • Leads Vendor bid defense meetings, • Manages the contract negotiation process for complex or high value contracts, • Demonstrates strong understanding of regulatory and legal issues pertinent to clinical development, • Is project focused and works with a sense of urgency Strategic Thinking • Ability to understand, analyze and develop recommendations from multiple complex sources such as financial and operational perspectives, • Influence vendor selection with stakeholders at the project team level Innovation • Identifies, develops, and deploys best practices in vendor selection, cost containment, and category management practices, • Leverages prior experience with external benchmarking, industry best practices, and technology for continuous improvement Problem Solving • Takes ownership of issues from problem identification to successful resolution, testing recommendations for reasonableness, • Triages study-level vendor management issues; escalates high-risk issues to appropriate stakeholders, • Translates trends in operational and systematic issues and develops solutions with sustainability in mind to ensure roadblocks are removed during study start-up Influence and Partnership • Engage with study team leadership to drive sourcing strategy, compliance, and continued partnership, • Exhibits competency in regularly establishing relationships with internal and external cross functional teams, such as clinical operations, legal, finance, compliance, • Partners with internal stakeholders working on contracts in resolving complex issues relating to contract negotiation or management, • Manages study level vendor relationships in conjunction with Clinical Operations Decision Making • Delivers value by developing business solutions by translating requirements into effective sourcing solutions, contractual terms and process improvements, • Asks probing questions to uncover business needs and recommends solutions (e.g., negotiating timelines while maintaining standards), • Demonstrated ability to make critical decisions related to clinical vendor agreement negotiations and escalations, • Consolidates data across functions according to business requirements and recommends vendors to senior leadership for endorsement, • Resolves vendor project management issues (e.g., operational challenges including scoping issues) by identifying and addressing deviations from established protocols, • Identifies operational and systematic issues, including frequency and escalates to the appropriate level Communication • Excellent communication skills and comfort level interacting with internal and external teams across all levels, including regular interface with stakeholders and leadership team members, • As necessary, trains internal stakeholders in contract budgeting, development, and administration Capabilities and Requirements • Experience in providing thought leadership and consistent customer service, • Expertise in the end-to-end sourcing and contracting process, including RFx, contract negotiation and change order management, • Demonstrates an in-depth knowledge of the clinical research process and the regulatory environment across functions, • Demonstrated leadership skills while working in fast paced and changing environment, • Financial acumen to review, analyze and understand cost drivers of complex budgets, • Legal, clinical operations and regulatory acumen Knowledge, Experience and Skills: • Relevant experience with a BA or MS in a relevant discipline, • MBA or JD preferred, • PMP/CPSM certification or equivalent a plus, • 5+ years of relevant experience

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.

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 Specialist III, Regulatory Lifecycle Maintenance is responsible for assisting in the development of global clinical regulatory strategy for investigational and marketed products and assists with the preparation of dossiers in eCTD format. This role will provide a high level of expertise to the organization in ensuring the conduct of clinical trials conform to Health Authority requirements. Essential Functions • Prepare or review documents including investigator brochures, protocols, clinical study reports , annual reports, DSURs, PAERs, clinicaltrials.gov entries, and other lifecycle maintenance documents., • Compile, organize, and catalogue essential regulatory documents on all active clinical studies to maintain compliance with Health Authorities., • Review, edit and approve all final submissions to Health Authorities., • Assist in daily operations outside of essential BLAs and provide regulatory input on day-to-day issues and provide regulatory documents to other departments., • Review clinical data, reports, and summaries for compliance with the protocol, statistical analysis plan, monitoring guidelines, and data management plan., • Assemble the reporting of clinical studies performed by IBRX or by CROs., • Draft written summaries for regulatory submissions including but not limited to, INDs, NDAs, and BLAs., • Provide support and training to others in the preparation, analysis, and documentation of studies., • Draft and review essential BLA documents (ISS, ISE, CSRs, Label, Module 2.5), appendix cataloguing, and reconciliation., • 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 a related field required; 5+ years of relevant regulatory clinical Science experience is required, or, • Master's degree in life sciences or a related field required; 3+ years of relevant regulatory clinical Science experience is required, • Experience in the preparation of the submission of clinical modules in eCTD format is preferred, • Familiar with organizing responses to Health Authority information requests is preferred, • Familiarization with regulatory submissions internationally is preferred. Knowledge, Skills, & Abilities • Knowledge of Health Authority clinical guidance documents and requirements, • Expert knowledge of clinical research, Good Clinical Practices, and regulatory requirements and guidelines, • Strong 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 Working Environment / Physical Environment • This position works on-site in Summit, NJ., • The 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., • Lift and carry materials weighing up to 20 pounds. 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. $132,000 (entry-level qualifications) to $145,200 (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 Manager, Lifecycle Maintenance will advance the maintenance global clinical regulatory compliance for investigational and marketed products and manage the maintenance of study files in eCTD format. This position will contribute to the organization in the design and conduct of clinical trials in conformance with Health Authority requirements and the management of clinical trial documentation to support clinical submissions. Essential Functions • Lead Lifecycle Maintenance staff 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., • Provide input to the design and reporting of clinical studies performed by IBRX or by CROs, • Manage the review, cataloguing, and submission of documents including investigator brochures, protocols, informed consent forms, clinical study reports, annual reports, DSURs, PSURs, PAERs, and clinicaltrials.gov entries in the US and abroad, • Manage all protocol supportive documentation including the cataloguing and submission of essential investigator qualification documents, • Review clinical data, reports, and summaries for compliance with the protocol, statistical analysis plan, monitoring guidelines, and data management plan, • Create and maintain project plans for regulatory lifecycle maintenance operations, • Monitor FDA and other healthauthority guidance, prepare supplemental dossiers, and manage the lifecycle documentation for postapproval changes., • Lead datadriven strategic initiatives to maintain comprehensive regulatory documentation, ensuring compliance and supporting organizational objectives., • Oversee configuration, maintenance, and user support for internal platforms used for file storage., • Participate in cross-functional teams and provide support to others in the preparation, analysis, and documentation of studies, • Serve as a trainer for Regulatory Affairs SOPs, processes, and templates for review, preparation, QC, and finalization of documents and major sections of applications, • Manage the internal review of the relevant clinical sections of written summaries for regulatory submissions including INDs, NDAs, and BLAs, • 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 7+ years relevant progressive experience required; or, • Master's degree in life sciences or technical discipline with 5+ years relevant progressive experience required; or, • Doctorate degree in life sciences or technical discipline with 3+ years relevant progressive experience required, • Experience managing staff preferred, • Experience in the management and preparation of the submission of clinical modules in eCTD format required, • Experience with organizing responses to Health Authority information requests required, • Familiarity with global regulatory submissions (US and ex-US) strongly preferred Knowledge, Skills, & Abilities • Strong knowledge of Health Authority guidance documents and requirements, • Strong leadership skills with the ability to direct and develop professional staff, • Strong knowledge of clinical research, Good Clinical Practices, and regulatory requirements and guidelines, • 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 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. $165,000 (entry-level qualifications) to $181,000 (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 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 . 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., • 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 US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

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 . 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 US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Job Description About Tonix* Tonix is a fully integrated biotechnology company, publicly traded on NASDAQ (ticker: TNXP), with marketed products and a pipeline of development candidates The Company is focused on commercializing, developing, discovering, and licensing therapeutics to treat and prevent human disease. In August 2025, Tonix received FDA approval for Tonmya™ (cyclobenzaprine HCl sublingual tablets), a first-in-class, once-daily, non-opioid treatment for fibromyalgia. Tonmya is the first new fibromyalgia therapy approved in over 15 years, following successful Phase 3 trials demonstrating significant symptom improvement. Commercial launch is expected in the fourth quarter of 2025. Tonix also markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg, both indicated for the treatment of acute migraine with or without aura in adults. Tonix’s development portfolio includes product candidates in central nervous system (CNS), immunology, immuno-oncology infectious disease and rare disease. The CNS pipeline features both small molecules and biologics to treat pain, neurologic, psychiatric, and addiction conditions. The immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, which also serves as a live virus vaccine platform for other infectious diseases. Finally, the rare disease portfolio includes a product in development for Prader-Willi syndrome, which has both orphan drug designation and rare pediatric disease designation grants from the FDA. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Please visit for specifics on the pipeline. *All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication. Position Overview Tonix is looking for a full-time Senior Director of Program and Portfolio Management (PPM) to effectively shape and implement PPM strategies decision making for a complex portfolio of drug development programs and execution of decisions. The Senior Director of PPM will be a responsible for implementing portfolio management best practices, drafting strategic and operational plans, mentoring project managers (PM) and operational staff, and supporting effective communications across multiple departments at Tonix. The individual in this position will also be responsible for building out the team of PMs which would report into this role. This is a fast-paced, challenging position offering a competitive compensation and benefits package. This position will report directly to the Company’s Chief Operating Officer that will ideally be based at the Tonix Chatham, NJ office. Essential Duties • Lead and manage cross-functional teams interacting with clinical, nonclinical, regulatory, CMC, discovery, and others to set priorities, work toward goals and monitor progress of programs, • Develop portfolio tools and materials to support portfolio decision-making, • Create, implement, and refine PPM practices to support leadership, PPM staff, and delivery of program goals, • Lead regular portfolio operations committee meetings and portfolio strategy sessions, • Coordinate and manage due diligence teams and decision making on in licensing activities for the portfolio, • Help to buildout and lead PMs responsible for developing cross-functional program plans, timelines, and budgets in collaboration with functional area leads, • Facilitate effective, science-based business decisions including development of scenarios and strategic impact of decisions, • Ensure all decisions are assessed as to their risks and impacts as well as accountable for communication to team and stakeholders in a transparent and timely manner, • Function as an integrator within the project team and across the Company to ensure alignment, • Develop and coordinate resource and budget planning activities across functions to ensure adequate resources are applied to the programs and decisions are assessed for portfolio impact, • Provide leadership to teams and functional areas to proactively anticipate and identify project issues which pose a challenge to achieving strategic goals; propose and implement plans to resolve such issues, and execute corrective actions, • Effectively execute change management to implement strategies for effecting, controlling, and helping teams adapt to change, • Provide updated project information for the Board as well as for regular budget and portfolio reviews, • Enable high-performing teams by ensuring good team dynamics within the project team, • Follow all established occupational health and safety procedures, good manufacturing practices (GMP’s) and standard operating procedures (SOP’s), • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork, • Recruits, interviews, hires, and trains new team members, • Oversees the daily workflow of the department, • Provides constructive and timely performance evaluations, • If necessary, handles discipline and termination of employees in accordance with company policy, • Bachelor’s degree and fifteen (15) years of relevant project / program / portfolio management experience within the pharmaceutical / biotechnology industry; or a PhD in a scientific field or a PharmD, DVM or MD degree with ten (10) years of relevant experience preferred, • Scientific background and/or MBA preferred, • Ten (10) years of leading cross-functional program or portfolio management activities within the pharmaceutical industry with a deep understanding of practices and standards of pharmaceutical program and portfolio management preferred, • Experience managing PM professionals in the drug development industry, • Strong leadership presence with the ability to translate strategy into action, • Excellent analytical skills with an ability to summarize and present complex information in a clear and concise manner to support decision-making, • Ability to create an inclusive environment and lead empowered teams who operate with high standards of alignment, trust, accountability, expertise, transparency, and collaboration, • Outstanding verbal and written communications skills with the ability to effectively interact with and influence all levels within the company, • Ability for minimal travel, • Dedicated team player who is able to withstand the high demands of a fast-paced environment Tonix does not accept agency resumes unless contacted directly by internal Tonix Talent Acquisition. Please do not forward resumes to Tonix employees or any other company location; Tonix is not responsible for any fees related to unsolicited resumes. Compensation & Benefits Annualized base salary ranges from $200,000 to $300,000 plus target incentive; actual salaries will vary and may be above or below this range commensurate with several factors including experience, education, training, location, and merit. Tonix provides a comprehensive compensation and benefits package which includes: • Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, Health Savings Account, and Employee Assistance Programs, • Pet Insurance, • Retirement Savings 401k with company match and annual discretionary stock options, • Generous Paid Time Off, Sick Time, & Paid Holidays

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 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 . 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., • 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., • 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 US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

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, • 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., • 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)

Job Description Come join our team and make a difference as we blaze the way into the future of medical discovery through world-class clinical research. At Summit Pinnacle Clinical Research, we are committed to driving innovation and advancing medical knowledge. Through our rigorous research studies, we strive to unlock breakthroughs that have the potential to transform patient care and improve lives. We pride ourselves on conducting high quality research as a complement to the medical care that our volunteers receive from their routine care center. Together, we will raise awareness about the importance of clinical research and its role in shaping the future of healthcare. Be a part of the discovery! Summary: Summit Pinnacle Clinical Research seeks a Research Pharmacist, responsible for performing the day-to-day operations of clinical trials and office support activities for the pharmacy to facilitate the efficient operation of the Clinical team. They will attend meetings and events to promote studies, work closely with Clinical team to assist and cross train, as well as document and report on the daily operations of pharmacy activities and status. This person must be able to understand clinical research priorities and establish a workflow to complete all required activities in a timely manner. This position is responsible for a broad range of duties involving confidential information. The Research Pharmacist must be organized, excel at multi-tasking, detail-oriented, an excellent written and oral communicator, and be able to provide high quality patient care. This person will collaborate very closely with other members of the SPCR team, external vendors, and therefore must be highly collaborative, goal-oriented, flexible, and communicative. An ideal candidate will be responsive, thoughtful, empathetic, self-motivated, and a team-player. This role reports directly to the Site Director. Duties and Responsibilities: • Receive investigational product (IP) shipments on site., • Account for all shipment contents and complete required documentation., • Confirm in sponsor assigned vendor portal (example: IWRS/IXRS/EDC) shipment received or notify sponsor that shipment was received if there was no IWRS/IXRS system., • Document shipment and its contents on the IP logs., • Upload monthly temperature logs within the first week of the month for individual or multiple sites., • Assessing, documenting, and reporting temperature excursions as they occur to include completion of any excursion paperwork provided by the sponsor., • IP dispensing and return accountability from clinical team., • Double verification of IP dispensation and returns., • Manage pharmacy documentation within the appropriate system (e.g. CRIO, Vestigo), • Host unblinded routine monitoring visits., • Daily reconciliation of applicable pharmacy logs, • Maintain pharmacy organization and current IP supply., • Coordinate routine temperature monitor calibrations., • Complete manual temperature recording as applicable., • Perform IP administration if applicable., • Orders supplies as needed from local pharmacy or selected vendors if applicable., • Maintains pharmacy supply inventories., • Ensures appropriate temperature conditions for pharmacy and pharmacy equipment (i.e. refrigerators and freezers), • Provides training to support staff members., • Coordinates the return of IP with Sponsor/CRO, • Calls in prescriptions on behalf of PCR for patients if applicable to site process., • Labels IP for internal tracking, • Provides subjects with IP instruction and education if applicable., • Collaborate and cross-train with Clinic personnel if applicable at site., • Always maintain subject and document confidentiality, understand, and comply with the appropriate sponsor requirements and regulations which include the Food and Drug Administration, good clinical practices, International Conference on Harmonization, Health Insurance Portability and Accountability Act, institutional review boards, and institutional policies and procedures, • Create and maintain reports and/or spreadsheets as requested., • Assist with maintaining study documents and electronic regulatory documents. Qualifications: • Registered Pharmacist (RPh) or Doctor of Pharmacy (PharmD), • Proficient in all Microsoft Office applications, • Demonstrated organizational skills and outstanding time management, including keen attention to detail with the ability to track multiple projects at one time., • Strong written and oral communication skills, • Knowledge of basic medical terminology, • 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 always. Knowledge Skills and Other Abilities: • Must be able to effectively communicate with all levels of internal and external contact., • Ability to work independently and multi-task in a fast-paced team environment., • Strong people skills include ability to interact with individuals from diverse backgrounds and to oversee confidential matters and sensitive information with discretion and judgment., • Must possess a positive, friendly, and professional demeanor, particularly when interacting with patients., • Must be able to work independently and collaborate with a team., • Ability to interpret and adhere to clinical research protocols., • Strong problem-solving and decision-making skills, particularly when under pressure, • Proactive at identifying, addressing, and solving issues in real time., • Energetic self-starter, results oriented, and the ability to work effectively in an entrepreneurial environment. Certificates and Licenses: Valid Driver’s License Work Environment and Physical demand: 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., • 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., • 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. Perks of working at Summit Pinnacle Clinical Research: • 401k, • Medical, dental, vision and more, • 3 weeks of paid time off, • 14 paid company holidays, • Scrub voucher (specific positions apply)

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 . 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 US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: