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Job Description Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 100+ clinical research sites across the US and Europe, accelerating the path to market for novel therapies. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need. About the Role Iterative Health is redefining how clinical trials are conducted in IBD, and we're looking for a commercial leader to help scale that impact. As Manager of Life Sciences, you will drive the next chapter of Iterative Health's growth in the biopharma and biotech ecosystem, owning and expanding relationships with our most important sponsors. This is a high-visibility, client-facing role for a builder - someone who thrives on creating value in complex partnerships, influencing senior stakeholders, and driving outcomes that matter. You'll be the connective tissue between sponsors and Iterative's internal teams, ensuring we deliver on every commitment while shaping how we evolve our solutions to meet the future of clinical research. This role is ideal for a relationship-driven commercial leader who thrives in high-growth environments and enjoys building deep, strategic partnerships in the life sciences space. Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 100+ clinical research sites across the US, Europe, and Asia, accelerating the path to market for novel therapies. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need. About the Role We are seeking an experienced and execution-oriented Manager, Life Sciences to own day-to-day sponsor and CRO partnerships across our active clinical trial portfolio. This is a high-visibility, cross-functional role at the operational center of our business — sitting at the intersection of sponsor relationships, site operations, business operations, and clinical research delivery. Reporting to the Associate Director of Life Sciences, you will serve as the primary point of accountability for a wide roster of accounts, leading high-impact meetings with sponsors and other research partners, driving trial recruitment and activation performance against committed targets, and acting as the connective tissue between commercial commitments and the operational teams that deliver against them. You will also help build the analytics, reporting, and tooling that scales sponsor account management as the network grows. Responsibilities • Own end-to-end client relationships across multiple active trials, including weekly operational meetings, quarterly business reviews, and general strategic conversations with sponsor and partner stakeholders, • Serve as the escalation point for cross-functional issues spanning operations, legal, finance, and clinical regulatory - translating client needs into internal action and internal capacity into sponsor commitments, • Prepare and present sponsor-facing materials including weekly status updates, quarterly business reviews, recruitment briefers, and ad-hoc analyses for executive and partner stakeholders, • Contribute to commercial strategy and forecasting by partnering with the team on pipeline opportunities, feasibility responses, and contract amendments, • Build and maintain analytics and reporting tooling - including custom dashboards and AI-driven workflows - to scale account coverage and speed up decision-making, • Mentor junior team members; set the bar for cross-functional communication, sponsor responsiveness, and operational rigor across the Life Sciences function, • 4+ years of experience in alliance management, sponsor or partner-side trial delivery, or adjacent commercial roles, • Demonstrated ownership of multi-stakeholder sponsor or partner relationships, including executive-facing communication, • Excellent written and verbal communication; able to write tight briefs and run a focused weekly meeting with multiple external stakeholders, • Highly organized and self-directed; comfortable carrying multiple active sponsor relationships and concurrent workstreams without external project management, • Commercial mindset with a bias toward action, • Strong cross-functional collaboration skills, with a track record of moving work through legal, finance, operations, and clinical functions, • Comfortable in processing / analyzing disparate forms of data, • Direct experience in GI, Hepatology, Cardiology, or other therapeutic areas, • Experience working with mid-size and large biopharma sponsors and global research partners, • Familiarity with the systems used in modern clinical operations, • Experience building or driving adoption of internal tooling, automation, or AI-assisted workflows

Job Description Overview About Us: Anvia Therapeutics is a dynamic and innovative biotech company dedicated to developing small molecule inhibitors targeted at treating inflammatory and autoimmune diseases. We foster a collaborative environment where scientific excellence and creativity drive our mission to develop impactful medicines. Overview The Senior Director, Clinical Development Operations is responsible for providing strategic direction and operational excellence across all phases of clinical development programs. This key leadership role oversees the planning, execution, and oversight of clinical trials from early-phase through market filings, ensuring program objectives are achieved within established timelines, budgets, and quality standards. This position reports directly to the Chief Executive Officer. Responsibilities Essential Responsibilities Strategy & Leadership • Ensures clinical trial objectives are aligned with clinical development strategy and overall corporate strategy., • Generates progress reports and presents clinical program strategy and status updates to Senior Management., • Directs the planning and execution of clinical trials across all phases of development, from early development through NDA/regulatory submissions., • Accountable for clinical program and study timelines, budgets, and managing actual spend to approved budgets, including tracking actuals and communicating deviations., • Oversees quality and risk management of clinical development programs, ensuring adherence to SOPs, GCP, ICH guidelines, and FDA regulations., • Oversees the development and implementation of clinical trial systems and workflows (e.g., IRT/IXRS, central lab, eCOA) including design, specifications, and UAT., • Oversees full-service CRO and vendor management activities, including RFP, vendor selection, scope of work development, performance management, and vendor governance., • Authors and/or contributes to regulatory documentation and filings (e.g., IB, IMPD, IND) and correspondence with regulatory authorities and ethics committees., • Contributes to the writing, review, and finalization of clinical study protocols, Investigator Brochures, and clinical study reports., • Provides leadership, mentorship, and direction to the Clinical Development Operations team; responsible for recruiting, developing, training, and retaining top talent., • Ensures prioritization of activities and resourcing is aligned with clinical development program needs., • Develops and maintains company SOPs, work instructions, and training for Clinical Operations activities., • Constructively manages conflict within development teams and ensures timely resolution of issues., • Fosters a collaborative, highly integrated, and innovative team culture. Qualifications Qualifications • BA/BS in life sciences or a health-related field required, • Minimum 12+ years of progressive clinical operations and/or development operations experience within the pharmaceutical or biotechnology industry., • Demonstrated experience in clinical development programs and teams spanning early to late phase clinical development, • 5+ years of people management and leadership experience with a proven track record of building and developing high-performing teams., • Demonstrated working knowledge of ICH/GCP guidelines, data management, clinical systems, statistical programming, medical writing, pharmacokinetics/pharmacodynamics, protocol design, and drug product development and distribution., • Experience with global project teams and ability to work across multiple time zones and languages preferred., • Proficiency with MS Office Suite (Word, Excel, PowerPoint, Outlook, Project)., • Highly adaptable with the ability to thrive in a fast-paced, start-up or clinical-stage environment and develop creative solutions with limited infrastructure., • Excellent interpersonal skills with strong oral and written communication abilities., • Innovative, analytical, and highly organized with the ability to drive multiple projects to completion simultaneously., • Proven experience working at the senior management level and recognized as a strong leader in a high-science organization., • Willingness to travel up to 30%, as needed, to support clinical development programs. The salary range for this position is $200,000-$260,000 per year. The actual compensation offered will be based on factors such as relevant experience, education, and skills. In addition to base salary, we offer a comprehensive benefits package, including health insurance, paid time off, and retirement plan options. Our employment decisions are based on merit, qualifications, and business needs. We are committed to providing a work environment free from discrimination, harassment, and retaliation, and we undertake affirmative action efforts to promote equal opportunity for all employees and applicants. #LI-DNI

Job Description Clinical Research Coordinator (Dermatology Clinical Trials) A well-established dermatology practice with 34 years of clinical excellence, is seeking a Clinical Research Coordinator (CRC) to join team. The practice has successfully completed hundreds of dermatology clinical trials since 1992, working closely with leading pharmaceutical sponsors to advance innovative dermatologic therapies.This position offers the opportunity to work alongside board-certified dermatologists and experienced research professionals in a collaborative, patient-focused environment. Position Summary The Clinical Research Coordinator is responsible for coordinating and managing daily activities related to dermatology clinical trials while ensuring full compliance with FDA regulations, ICH-GCP guidelines, and IRB requirements. The CRC plays a key role in study execution, participant management, regulatory documentation, and communication with sponsors and study monitors. Key Responsibilities · Screen, recruit, and enroll participants for dermatology clinical trials · Conduct informed consent discussions with study participants · Coordinate and perform study visits according to protocol requirements · Maintain accurate source documentation and Case Report Forms (CRFs) · Ensure compliance with FDA, GCP, and IRB regulations · Manage investigational product accountability and study materials · Document and report adverse events (AEs) and serious adverse events (SAEs) · Maintain regulatory files including Trial Master Files (TMF) · Assist physicians with dermatologic study procedures · Obtain standardized pre- and post-treatment clinical photography · Communicate with sponsors, monitors, and internal research staff throughout the study Qualifications · Prior experience as a Clinical Research Coordinator or research assistant · Dermatology clinical research experience strongly preferred Knowledge & Skills · Understanding of Good Clinical Practice (GCP) and FDA regulations · Knowledge of clinical trial processes and medical terminology · Familiarity with HIPAA and research compliance standards · Strong organizational and documentation skills · Ability to manage multiple studies and deadlines simultaneously · Excellent interpersonal and communication skills · Professional demeanor when interacting with patients, physicians, and sponsors · Ability to work both independently and within a team Additional Requirements • CPR certification preferred, • Occasional travel may be required for sponsor training meetings Company DescriptionWe provide full-service Healthcare Recruitment solutions. We identify, attract, engage, and connect the best possible talent with quality healthcare professionals. We build teams, provide executive recruitment solutions and discover high-performance candidates on behalf of our client partners. Our strength lies in our proven recruitment strategies, leadership in the larger healthcare community (regional and national), and networking.We provide full-service Healthcare Recruitment solutions. We identify, attract, engage, and connect the best possible talent with quality healthcare professionals. We build teams, provide executive recruitment solutions and discover high-performance candidates on behalf of our client partners. Our strength lies in our proven recruitment strategies, leadership in the larger healthcare community (regional and national), and networking.

Job Description Title: Clinical Research Coordinator, Psych exp. preferred Location: Staten Island, NY About us: ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with expertise in early and late-stage neuroscience drug development. With 20 wholly owned clinical sites and 4 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 400+ in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, Acute and Chronic Pain, diabetes, and other illnesses as well as normal healthy volunteers who participate in trials for the advancement of medicine. With access to over 32 million patients/subjects and 5000 + completed trials, ERG continues to grow its capabilities and expand into indications where there are tremendous unmet medical needs in the United States and globally. Job Description: The Clinical Research Coordinator is responsible for the overall coordination, organization, management, and efficient implementation of clinical trials. The CRC completes all study related procedures and distributes study medication and instructions to research subjects under the direction of the Principal Investigator and the Site Director. They maintain accurate, confidential files and documentation of study participants. In executing these position responsibilities, the Clinical Research Coordinator is guided by FDA regulations, Good Clinical Practice (GCP), and company standard operating procedures and policies. Responsibilities: General: • Obtain detailed knowledge of study protocols by reviewing with Principal Investigator (PI) and Site Director., • Assist in drafting and reviewing source documents for accuracy before study start-up., • Collaborate with PI and Site Director to clarify study components as needed., • Perform delegated study activities under Site Director’s supervision., • Attend investigator meetings as directed., • Ensure protocol adherence and report breaches to sponsors and regulatory bodies., • Screen, enroll subjects, schedule visits, and document communications., • Assist PI in maintaining data integrity and subject safety., • Enter study data (paper or electronic) and track adverse events., • High School Diploma required; college degree preferred., • 2-4 years of experience or Clinical Research Coordinator certification., • Strong communication, medical terminology knowledge, and problem-solving skills., • Familiarity with GCP, ICH guidelines, and regulatory requirements., • Proficient in Word, Excel, and clinical research software.

Job Description About Cleerly We're Cleerly – a healthcare company that's revolutionizing how heart disease is diagnosed, treated, and tracked. We were founded in 2017 by one of the world's leading cardiologists and are a growing team of world-class engineering, operations, medical affairs, marketing, and sales leaders. We raised $223M in Series C funding in 2022 which has enabled rapid growth and continued support of our mission. In December 2024 we received an additional $106M in a Series C extension funding. Most of our teams work remotely and have access to our offices in Denver, Colorado, New, York, New York, Dallas, Texas, and Lisbon, Portugal with some roles requiring you to be on-site in a location. Cleerly has created a new standard of care for heart disease through value-based, AI-driven precision diagnostic solutions with the goal of helping prevent heart attacks. Our technology goes beyond traditional measures of heart disease by enabling comprehensive quantification and characterization of atherosclerosis, or plaque buildup, in each of the heart arteries. Cleerly's solutions are supported by more than a decade of performing some of the world's largest clinical trials to identify important findings beyond symptoms that increase a person's risk of heart attacks. At Cleerly, we collaborate digitally and use a wide variety of systems. Our people use Google Workspace (GMail, Drive, Docs, Sheets, Slides), Slack, Confluence/Jira, and Zoom Video, prior experience in these areas is a plus. Role or department specific technology needs may vary and will be listed as requirements in the job description. While we are mostly a remote company, travel is required for some team meetings and cross function projects typically once per month or once per quarter, for some roles like sales or external facing roles travel could be up to 90% of the time.Cleerly is committed to providing safe and effective medical software that meets customer needs and our intended use. The adherence to all applicable regulatory and statutory requirements establishes a clear framework for setting measurable quality objectives. Our commitment to continually improving our products and processes proactively manages risks, ensuring ongoing compliance throughout the entire software lifecycle. Understanding this role's relevance and importance is critical to achieving Cleerly's quality objectives. About the Opportunity We are seeking a highly skilled Machine Learning Scientist to drive the development and translation of cutting-edge ML models that have a direct impact on the care pathway for heart disease diagnosis and prognosis. In this role, you will collaborate with ML scientists, data engineers, biostatisticians, regulatory experts, and senior leadership to understand clinical requirements, develop innovative solutions, and support product development and regulatory approvals. You will also engage in high-impact research collaborations with world-renowned academic and medical institutions. Responsibilities • Research and develop state-of-the-art machine learning models for coronary CT angiography imaging applications., • Conduct rigorous analysis and validation of machine learning algorithms and prototypes., • Explore novel methods for processing and analyzing large, complex medical imaging datasets., • Collaborate with engineering teams to deploy ML algorithms in clinical practice., • Present research findings, insights, and recommendations to internal stakeholders and external collaborators., • Author scientific publications and contribute to patent development., • Ph.D. in Computer Science, Data Science, Biomedical Engineering, Biomedical Imaging, or a related technical field; OR an M.S. with 5+ years of relevant experience., • Strong theoretical and practical expertise in image science, applied mathematics, machine learning, and deep learning., • Research experience in applying ML and deep learning techniques to medical image processing, including segmentation, registration, classification, reconstruction, and detection., • Proven track record of publications in top-tier medical imaging or computer vision conferences and journals (e.g., MICCAI, IEEE TMI, CVPR, Medical Image Analysis)., • Proficiency in Python, with experience handling large datasets, implementing ML pipelines, and visualizing analysis results., • Ability to translate complex clinical requirements into machine learning solutions., • Strong critical thinking, problem-solving, and project management skills., • 2+ years of postdoctoral research or industry experience., • Hands-on experience in developing and applying advanced deep learning models, including vision transformers, semi-supervised/self-supervised/unsupervised learning, incremental learning, and continuous learning techniques., • Candidates located in higher-cost labor markets, including California, Washington, New York, New Jersey, Connecticut, Massachusetts, and Washington, DC represent the middle to high end of the range, while candidates located in all other U.S. locations represent the low to middle end of the range., • Base Salary: $186,000 - $212,000 Working at Cleerly takes HEART. Discover our Core Values: • H: Humility- be a servant leader, • E: Excellence- deliver world-changing results, • A: Accountability- do what you say; expect the same from others, • R: Remarkable- inspire & innovate with impact OUR COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER. We do not discriminate on the basis of race, color, national origin, ancestry, citizenship status, protected veteran status, religion, physical or mental disability, marital status, sex, sexual orientation, gender identity or expression, age, or any other basis protected by law, ordinance, or regulation. For more information see our Privacy Policy (). All official emails will come from @cleerlyhealth.com email accounts. #Cleerly

Job Description POSITION TITLE: Clinical Document Management Specialist II DEPARTMENT: Clinical Document Management Ora Values the Daily Practice of … Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor At Ora, we are building the future of ophthalmic clinical research. As the world's leading full-service ophthalmic drug and device development firm, we guide our clients across all phases of clinical research to efficiently bring new products and therapies to market. Over the past 45 years, our expert teams have helped earn more than 85 new product approvals. Ora's pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global projects. Today, our team continues to expand across the globe, with over 600 employees across North America, Europe, Asia, and Latin America. The Role: Ora's Clinical Documentation Management Specialists II (CDMS II) is responsible for the management, quality and oversight of the electronic Trial Master File (eTMF) associated with all phases of assigned clinical trials (i.e., set-up through final transfer / archival). CDMS II's are crucial for ensuring Ora's clinical teams operate in compliance with SOPs and processes, study sponsor expectations and all applicable regulations. This role will focus on the quality of documents being uploaded to the eTMF and monitoring compliance to the TMF relative to inspection readiness and handle such issues independently and with oversight for escalations as needed. Additionally, our CDMS II's have the responsibility of preparing documentation required for regulatory agency inspections and internal audits. This role reports directly to the Manager while working in collaboration with various clinical study teams such as Quality Assurance, Chemical Manufacturing Control, and Medical Devices. Ora's CDMS II's will train to become Veeva Vault Super Users and be responsible for providing support and training to more junior team members, identify process improvements, handle escalations for documentation resolutions. What You'll Do: • Implement and administer Ora document management systems (Veeva Vault) and related procedures that allow Ora staff to capture, store, retrieve, share, and destroy electronic records and documents in a manner consistent and in accordance with SOPs, ICH GCP guidelines, FDA, and EU Directive (and other global regulatory agencies as needed)., • Manage documentation to ensure organization and accuracy., • Ensures clinical records are filed in a timely manner., • Perform quality-control (QC) review of clinical and regulatory documents submitted for entry into the eTMF and liaise with project teams towards documentation issue resolution., • Assist with the development of work processes and systems to support document management, including contributing to SOPs and internal department guidance. Supports initiatives to enhance efficiencies in document management practices. Propose recommendations for improving content management system capabilities., • Train towards and actively serve as a Veeva Vault Super-user who:, • Provides support and training to team members on processes and eTMF/CTMS software., • Supports staff towards resolution of ad hoc system issues., • Drives the resolution of identified documentation issues., • Develop and present training materials to educate trial team staff and CDMS I's on the usage of Veeva, Good Documentation Practices, Ora processes and regulatory guidelines., • Assist the clinical team in the close-out and archiving of clinical documentation and reports according to the scope of work and standard operating procedures., • Process and fulfill document requests from internal and external stakeholders for studies which have been archived in the eTMF., • Generate/review metrics reports intended as periodic review of study files for completeness., • Identify and classify documents or other electronic content according to characteristics such as security level, function, and metadata., • Prepare and record changes to eTMF documents and confirm changes with legal and compliance management staff., • Assist in the development of document or content classification taxonomies to facilitate information capture, search, and retrieval., • Assist in the preparation of support documentation and training materials for end users of document management systems., • Supports assigned TMF corrective action plans., • Responsibilities may differ slightly from the above based on specific needs of the business., • Clear and sustained demonstration of the Ora Clinical's Values of Customer Service, Leadership, Accountability, Results Oriented, Innovation and Teamwork, • Travel Requirements less than 10%, • Adhere to all aspects of Ora's quality system., • Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora's data integrity & business ethics and regulatory requirements., • Clear and sustained demonstration of Ora's values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor – as well as their linked behaviors., • Experience needed for the Role:, • Bachelor's degree with a minimum of 3 years' experience with clinical documentation and 3 years' experience with record management systems (eTMF) in the clinical research field or equivalent combination of work experience, education, and training. Years of experience may be considered in lieu of education, • Additional Skills and Attributes:, • Prior experience Veeva Vault, Montrium, Master Control, Documentum, Box is strongly preferred., • Familiarity with ICH GCP, DIA TMF Reference Model and regulatory guidelines/directives., • Familiarity with eTMF and CTMS software for document management activities., • Prior experience working in a CRO environment, • Familiarity with various aspects of clinical trials and regulatory submissions, as well as strong knowledge of document management best practices., • Detailed knowledge of regulatory requirements and ICH/GCP guidelines to support clinical records management., • Demonstrated ability to work independently, take initiative, complete tasks to deadlines and mentor other team members, • Ability to learn and apply SOPs and process governance regulations pertaining to clinical study documentation., • Requires strong attention to detail, document organization skills, establishing priorities, scheduling and meeting deadlines in order to meet business demands., • Ability to communicate at multiple levels both internally and externally and to concisely explain/rationalize responses to issues while able to guide study teams, sponsors and vendors towards the proper and most efficient manner of documentation and documentation maintenance., • Multi-lingual communication is a plus, • Competencies and Personal Traits:, • What We Do:, • Execution Excellence: Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work., • How We Do It:, • IQ, EQ and SQ: Agile and positive thinker, communicator and collaborator who uses a growth mindset to work and lead with authenticity, transparency, resilience, and empathy. Scientific, intellectual, and emotional/social curiosity creates the willingness and ability to innovate, make mistakes, learn and try again., • Clear and Direct Communication, Feedback and Conflict Resolution: Practice radical candor in your communication and participate in active Giving and receiving feedback frequently, with an open heart and mind creates psychological safety and promotes faster, individual, team and company growth., • Why We Do It:, • Well Being: Offering comprehensive healthcare options in Medical, Dental and Vision beginning day 1., • Flexible PTO & Unlimited Sick Time: Providing you the freedom to unwind and recharge when you need to in addition to 14 company paid holidays., • Financial: Competitive salaries along with a 401K plan through Fidelity with company match., • Family Support Care: Adoption and fertility assistance provided along with offering 16 weeks paid Parental Leave., • Company Paid Life & Disability Insurance: Offering peace of mind to help you and your family feel secure., • Remote & Wellness Reimbursement: We'll reimburse you to support your remote workspace and wellness purchases., • Employee Assistance Program: No matter what issues you're facing, New Directions is here to help you and your family., • Career Development Opportunities: Continued opportunities to grow and develop your career journey., • Global Team: Opportunities to work with colleagues across the globe. Our mission is to weave together people, processes, and technology to support innovation in ophthalmology around the world. We believe our business should be a force for good — to improve, heal, and change how we see. As a global company, our vibrant community and culture are nurtured by our core values: Prioritizing kindness, cultivating joy, operational excellence, and scientific rigor. Through our commitment to these values, we have built an inclusive and supportive work environment that fosters respect, accountability, and a fulfilling work-life balance for every team member. We know a diverse workforce adds to our collective value and strength as an organization. People of color, the LGBTQIA+ community, disabled candidates and veterans are strongly encouraged to apply. Ora is proud to be an Affirmative Action and Equal Opportunity Employer, committed to equal employment opportunity and fair, equitable compensation regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Our Privacy Policy | Ora (oraclinical.com)

Job Description Founded in 2009, EDETEK is a global leader in clinical technology and services, delivering high-quality, AI-powered platforms and solutions to pharmaceutical, biotechnology, and medical device companies. With a presence across four continents and a client base of over 100 biopharmaceutical companies, EDETEK is transforming clinical development through cloud-native technologies, intelligent data management, and automation. Our platforms are built for scalability, interoperability, and compliance. The Director of AI will lead the development and implementation of AI strategies to enhance clinical development processes. This role is responsible for architecting scalable AI solutions, guiding technical execution, and driving innovation across EDETEK’s AI product portfolio. The ideal candidate will have deep expertise in AI and clinical development for life sciences companies, with a strong background in machine learning, data science, and enterprise AI systems. This role requires a dynamic leader who thrives in a fast-paced, startup-like environment and can translate business goals into impactful AI solutions. Essential Functions and Responsibilities 1. AI Strategy & Leadership • Define and execute the AI vision aligned with EDETEK’s strategic goals., • Lead cross-functional teams to deliver AI-driven capabilities across clinical development., • Provide technical leadership and mentorship across the AI engineering team., • Inform and deliver on ambitious product roadmaps to accelerate growth. 2. AI Architecture & Development • Architect and build scalable AI infrastructure and solutions to support business growth., • Oversee model training, optimization, and deployment of end-to-end ML models., • Define best practices for AI/ML lifecycle management and governance., • Ensure compliance with industry standards and regulatory frameworks. 3. Collaboration & Stakeholder Engagement • Collaborate with stakeholders to translate business goals into technical solutions., • Partner with engineering, product, and clinical teams to integrate AI into platform capabilities., • Communicate AI strategy and progress to executive leadership and external partners. 4. Innovation & Technical Execution • Lead initiatives in advanced AI domains including transfer learning, generative models, and reinforcement learning., • Drive the development of enterprise knowledge management systems, NLP frameworks, and semantic data integration., • Master’s degree in Engineering, Computer Science, or a related quantitative field; advanced degree preferred., • 6+ years of hands-on experience in clinical trials and clinical development., • 3+ years of experience building and deploying AI/ML solutions and products., • Strong background in AI/ML fundamentals and software development., • Experience with modern databases, cloud environments, and data ecosystems., • Proven success in leading large-scale projects with multiple stakeholders., • Ability to thrive in a startup-mode environment and manage change effectively., • Excellent communication and interpersonal skills. Preferred Qualifications, • Expertise in transfer learning, unsupervised feature generation, meta-learning, generative text models, reinforcement learning, and Agentic AI., • Proficient in deep programming and production-grade AI implementation., • Experience designing enterprise knowledge systems, semantic web frameworks (RDF, OWL, SPARQL), and healthcare classification systems (SNOMED CT, CDISC, MeSH)., • Advanced data science and mathematical skills (e.g., PhD in computational modeling, machine learning, statistics, computer science). Why Join EDETEK?, • Opportunity to lead and innovate in a dynamic and growing company., • Collaborative and inclusive work environment., • Competitive salary and benefits package. Benefits vary by country, but remain competitive. Below is a sample of the benefits offered to U.S. employees. • Choice of comprehensive Medical, Vision and Dental Insurance plans, • Paid vacation time and sick days, • Corporate holidays annually, • Participation in the 401K Plan, • Comprehensive perks and discount programs for AAA, wholesale, insurance, Rx, fitness, pets, entertainment, etc.

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)

About Cleerly We’re Cleerly – a healthcare company that’s revolutionizing how heart disease is diagnosed, treated, and tracked. We were founded in 2017 by one of the world’s leading cardiologists and are a growing team of world-class engineering, operations, medical affairs, marketing, and sales leaders. We raised $223M in Series C funding in 2022 which has enabled rapid growth and continued support of our mission. In December 2024 we received an additional $106M in a Series C extension funding. Most of our teams work remotely and have access to our offices in Denver, Colorado, New, York, New York, Dallas, Texas, and Lisbon, Portugal with some roles requiring you to be on-site in a location. Cleerly has created a new standard of care for heart disease through value-based, AI-driven precision diagnostic solutions with the goal of helping prevent heart attacks. Our technology goes beyond traditional measures of heart disease by enabling comprehensive quantification and characterization of atherosclerosis, or plaque buildup, in each of the heart arteries. Cleerly’s solutions are supported by more than a decade of performing some of the world’s largest clinical trials to identify important findings beyond symptoms that increase a person’s risk of heart attacks. At Cleerly, we collaborate digitally and use a wide variety of systems. Our people use Google Workspace (GMail, Drive, Docs, Sheets, Slides), Slack, Confluence/Jira, and Zoom Video, prior experience in these areas is a plus. Role or department specific technology needs may vary and will be listed as requirements in the job description. While we are mostly a remote company, travel is required for some team meetings and cross function projects typically once per month or once per quarter, for some roles like sales or external facing roles travel could be up to 90% of the time. About the Opportunity We're seeking a Software Engineer 3 to drive key technical initiatives across our computational imaging pipeline. In this high-impact role, you'll be part of the team owning the complex systems responsible for deploying, scaling, and monitoring our regulated AI algorithms end-to-end. You will influence the architecture of our system, ensuring our solutions meet medical standards for quality and performance, while mentoring other engineers and helping shape our technical culture. About the Team You will join our expert Computational Imaging team, where we develop sophisticated algorithms to enhance and improve medical imaging. We are focused on improving the quality and clinical value of medical images, creating powerful, extra software components that correct artifacts, standardize data, and ensure the utmost precision before the final analysis. Our work is essential for elevating the reliability and accuracy of Cleerly’s regulated products. Responsibilities • Build and deploy scalable AI services and computational imaging pipelines to production, ensuring robust, high-availability infrastructure for our machine learning algorithms., • Contribute to the system architecture's design and make pragmatic trade-offs that balance performance, security, and maintainability., • Own full lifecycle delivery of complex features, from architectural planning and API design to implementation and post-release observability., • Support the high availability and observability of our services; improve alerting, logging, and incident response across the stack., • Uphold strong engineering standards via code reviews, technical mentorship, and design documentation., • Collaborate closely across AI and engineering to reduce knowledge silos and ensure continuity in critical systems through cross-training and documentation., • Implement robust testing mechanism and validation strategies to ensure compliance with our Quality Management System and regulatory standards Requirements • Bachelor’s or Master’s degree in Computer Science, Software Engineering, or related field (or equivalent experience)., • 5–8 years of software engineering experience, with expertise in AI production systems (Python, PyTorch) and data services (SQL, Postgres, NoSQL, Redis or similar)., • Demonstrable capability in designing, implementing, and securing RESTful web services, • Experience in MLOps orchestration and cloud deployment (Docker, Kubernetes)., • Experience with AWS, GitHub, and continuous integration pipelines, • Proven track record of delivering scalable systems in production environments., • Strong systems thinking with the ability to evaluate tradeoffs in scalability, reliability, and maintainability., • Experience designing for observability and operational excellence (e.g., logs, alerts, dashboards, runbooks)., • Comfortable operating in ambiguity and driving clarity across product, engineering, and business stakeholders. Preferred: • Experience designing and optimizing end-to-end medical imaging pipelines in a production environment and familiarity with HIPAA/HITRUST security requirements., • Hands-on experience with Computer Vision and Deep Learning techniques used for medical image processing. OUR COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER. We do not discriminate on the basis of race, color, national origin, ancestry, citizenship status, protected veteran status, religion, physical or mental disability, marital status, sex, sexual orientation, gender identity or expression, age, or any other basis protected by law, ordinance, or regulation. Job duties, activities, and responsibilities are subject to change by our company. The base salary range for this role varies by location and is aligned to market benchmarks. • Candidates located in higher-cost labor markets, including California, Washington, New York, New Jersey, Connecticut, Massachusetts, and Washington, DC represent the middle to high end of the range, while candidates located in all other U.S. locations represent the low to middle end of the range., • Final compensation is determined based on location, experience, skills, and internal equity. This role is eligible for a 15% target annual bonus, resulting in the following base salary and Total Target Compensation (TTC) ranges: • Base Salary: $129,000 - $152,000, • TTC: $142,000 - $168,000 *Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.) Additionally, stock options, paid benefits, and employee perks are part of your total rewards. Working at Cleerly takes HEART. Discover our Core Values: • H: Humility- be a servant leader, • E: Excellence- deliver world-changing results, • A: Accountability- do what you say; expect the same from others, • R: Remarkable- inspire & innovate with impact, • T: Teamwork- together we win Don’t meet 100 percent of the qualifications? Apply anyway and help us diversify our candidate pool and workforce. We value experience, whether gained formally or informally on the job or through other experiences. Job duties, activities and responsibilities are subject to change by our company. OUR COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER. We do not discriminate on the basis of race, color, national origin, ancestry, citizenship status, protected veteran status, religion, physical or mental disability, marital status, sex, sexual orientation, gender identity or expression, age, or any other basis protected by law, ordinance, or regulation. For more information see our Privacy Policy (___. All official emails will come from @cleerlyhealth.com email accounts. #Cleerly

Company Overview: Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons’ most difficult challenges in treating patients with aortic diseases. Artivion’s four major groups of products include: aortic stent grafts, surgical sealants, On-X mechanical heart valves, and implantable cardiac and vascular human tissues. Artivion has over 1,400 employees worldwide with sales representation in over 100 countries. The Company has manufacturing facilities located in Atlanta, Georgia, Austin, Texas and Hechingen, Germany. Additionally, it has sales and distribution offices in various countries throughout Europe, Asia, and South America. For additional information about Artivion, visit our website, ___. Position Overview: In this role, you will lead the development and execution of the commercialization strategy for the next generation Endovascular Aortic Arch Repair (EAAR) stent graft portfolio at Artivion. You will be responsible for leading upstream voice of customer (VOC) activities and engaging with external vascular surgeon customers to translate market needs into product opportunities. You will represent the customer's perspective, ensuring new product concepts are market-driven and commercially viable, and manage the introduction of new products through launch. The right candidate will be naturally collaborative, customer- centric, and able to manage the shifting priorities of multiple projects in a highly visible role within the organization. Position Responsibilities: • Collaborate heavily and assume a leadership role within the Endo Aortic Arch, and Bridging Stent cross functional core teams, providing product marketing support in meeting key project milestones and deliverables., • Develop and execute voice of customer and market research initiatives to inform product pipeline and drive commercial requirements (customer, product, business needs)., • Interface regularly with customers and regional partners through travel, congresses, and symposia to better understand and deliver on customer needs., • Partner closely with key opinion leaders to anticipate the future market environment, changes in trends, competitive landscape, and to predict/drive future needs., • Support trial site selection, training, and engagement throughout clinical trials., • Develop and manage KOL cardiac and vascular surgeon relationships for the product portfolio., • Collaborate with Sales Leadership in developing a commercialization plan and integrated marketing plan for the Endovascular Aortic Arch portfolio., • Develop training and marketing materials to prepare for commercial launch., • Manage a marketing budget quarterly and execute as defined in the marketing plan., • Illustrate project management expertise. Qualifications: • Bachelor’s Degree in area such as business, engineering, or life-sciences., • 8+ years experience in medical industry. Previous product management experience in the vascular or cardiac surgery space preferred., • Strong clinical acumen, and ability to come up to speed quickly on new products and disease states., • Proven ability to conduct opportunity assessments, market sizing, and roadmap development, along with strong experience in VOC research and competitive analysis., • Strong analytical skills, including a proven ability to plan and execute market research initiatives as well as synthesize market and customer insights., • Strong understanding of the product development lifecycle and experience working closely with a range of cross-functional business partners., • Good organizational and project management skills, with ability to manage multiple tasks to meet tight deadlines in an environment of competing priorities., • Highly collaborative and consistently pushes self and others to achieve challenging goals and objectives with a track record of executional success.

Who We AreInato is a Tech for Good company striving to bring clinical research to each and every patient, regardless of who they are or where they live. To do this, we are building the world's first clinical trial platform to create greater visibility, access, and engagement across a more diverse population of doctors and their patients. Drug development is a challenging, intellectually complex, and rewarding endeavor: we enable global pharmaceutical companies to confidently partner with community-based researchers to increase patient access to the latest medical innovations. Our AI-powered platform currently offers clinical trials from leading companies to over 5,500 sites across the globe and we are well poised for growth in 2025. We are a growing team of passionate pharmaceutical experts, software and AI engineers, professional services members, and many more—all bringing their unique perspectives to solve the challenges facing clinical research. Inato is the recent recipient of Fast Company’s Most Innovative Companies of 2024, Fierce Healthcare’s Fierce 15, and Built In's Best Places to Work 2025. The RoleWe’re seeking a Senior Product Manager to join our Trial Matching Squad and drive meaningful change in how research sites engage with clinical trials. You’ll work at the intersection of user needs, product strategy, and execution to deliver features that increase trial applications and site engagement. You’ll be part of a close-knit, cross-functional team that includes Engineering, Design, and Customer Success. This is an opportunity to make a career-defining impact in a regulated industry that is ripe for transformation. Responsibilities-Own end-to-end product initiatives that enhance site experience and improve application engagement.-Lead discovery by conducting user interviews, digging into usage data, and synthesizing insights to inform product decisions.-Collaborate cross-functionally with engineering, design, and GTM teams to deliver impactful, user-centric solutions.-Navigate the complex needs of diverse stakeholders, including physicians, trial coordinators, and sponsor-side decision makers.-Actively contribute to roadmap planning, product rituals, and continuous delivery processes.-Launch and iterate on features, using data and customer feedback to drive adoption and business outcomes. Qualifications Must-Have-3–6+ years of product management experience in B2B SaaS or regulated environments (healthcare, life sciences, fintech, or govtech preferred).-Strong ownership mindset—you take initiative, ask questions, and follow through relentlessly.-Mission-driven and passionate about improving healthcare equity.-Experience operating in complex stakeholder ecosystems where the user, buyer, and influencers are distinct.- White we are a remote first company, we are looking for someone based in New York City, with a willingness to collaborate in-person with another product manager 1-2 flexible days per week. Bonus PointsBackground in clinical trial technology or life sciences.Proficiency with discovery tools (e.g., user research, analytics) and delivery tools (e.g., Jira, Figma).Experience growing into senior product roles within high-growth startups or scale-ups.Strong written and verbal communication skills. Benefits6 weeks vacation + 9 company holidays + 4 floating holidays16 weeks paid parental leaveComprehensive health insuranceCompetitive salary & equity We strictly prohibit unlawful discrimination or harassment on the basis of race, color, religion, veteran status, national origin, ancestry, pregnancy status, sex, gender identity or expression, age, marital status, mental or physical disability, medical condition, sexual orientation, or any other characteristics protected by law. We also make reasonable accommodations to meet our obligations under laws protecting the rights of the disabled.$160,000 - $200,000 a year

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for a Senior PKPD Programmer Consultant to join one of our clients. ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts. We are seeking an experienced Senior PK/PD Programmer to support pharmacokinetic (PK) and pharmacodynamic (PD) analyses across clinical development programs. This role is responsible for creating analysis datasets, generating tables/listings/figures (TLFs), supporting modeling activities, and ensuring high-quality deliverables for regulatory submissions. The ideal candidate has strong programming expertise (SAS and/or R), experience with NONMEM or other modeling tools, and a solid understanding of clinical pharmacology. Programming & Analysis * Develop and validate PK/PD analysis datasets (ADaM, SDTM as applicable). * Generate Tables, Listings, and Figures (TLFs) for PK/PD studies. * Support population PK, exposure-response, and other modeling analyses. * Perform data cleaning and reconciliation between clinical and PK datasets. * Ensure compliance with CDISC standards (SDTM, ADaM). Modeling Support * Support pharmacometricians in NONMEM, Monolix, or similar modeling platforms. * Prepare analysis-ready datasets for modeling. * Assist with model diagnostics, simulations, and reporting outputs. * Create graphical outputs for clinical study reports and regulatory submissions. * Perform QC and validation of programming outputs. * Support regulatory submissions (IND, NDA, BLA, etc.). * Maintain documentation for programming activities. * Work closely with Clinical Pharmacology, Biostatistics, Data Management, and Medical Writing teams. * Participate in study team meetings and provide programming input. * Mentor junior programmers when needed. Experience * 5–8+ years of programming experience in clinical trials. * 3+ years of PK/PD programming experience. • Experience with NMPKPD and ER datasets., • Experience in Early-Stage Development studies. Experience with R programming preferred. * Working knowledge of NONMEM, Monolix, Phoenix WinNonlin, or similar tools. * Experience with CDISC standards (SDTM, ADaM). * Strong data manipulation and visualization skills. Education * Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, Life Sciences, or related field. The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. #LI-TT1 #LI-Remote #Senior#Contract

Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23. Role Summary: The Sr. Director of Biostatistics will provide leadership and strategic input for clinical development programs assigned. The selected individual will be responsible for statistical activities supporting clinical trials, including contributing to trial designs, authoring statistical sections of protocols, preparing statistical analysis plans, and reviewing and interpreting the analysis of clinical trial data. This is a hands-on role where you will interact with internal and external cross-functional study teams, support interactions with Health Authorities globally, conduct ad-hoc analyses, and manage biometrics vendors in preparing analysis files, performing statistical analyses, and delivering analysis results and data files. Key Responsibilities: • Lead the biometrics team including statistician, data manager, and statistical programmer at a program level., • Provide statistical input to strategic planning, study design, protocol development, sample size calculation, CRF, Results Interpretation, clinical study report, and address questions from regulatory agencies., • Promote research of advanced and innovative statistical methods to increase probability of success of clinical studies., • Author and develop SAPs, and work with extended team or vendor in developing specification for derived variables, templates of statistical tables, figures, and listings., • Provide guidance to study team on all aspects of statistical activities; collaborate closely with data manager to ensure high-quality data., • Participate in cross-functional study-related activities; Work collaboratively with Clinical Development, Clinical Operations, Clinical Data Managers, Pharmacovigilance ＆ Epidemiology, Regulatory, Project Management, Translational Medicine, and other staff and vendors to meet project deliverables and timelines., • CRO / Vendor Oversight: Establish procedures through regular interaction, setting expectations on deliverables and timelines. Ensure deliverables are accurate and delivered according to timelines., • Global Health Authority Interaction: Contribute to documents submitted to Health Authorities globally by providing input for the interaction or by writing the interaction document. May participate in meetings or teleconferences with Health Authorities., • Coordinate with internal and external team members to prepare the statistical analyses for IB, DSUR updates, periodic safety updates, and other ad hoc analyses., • Build and develop efficient biostatistical processes and standards., • Other duties as assigned. Ideal Candidate: • PhD Degree in Biostatistics, Statistics, or a related field with at least 10-12 years of experience in biostatistics within the pharmaceutical, biotech, or CRO industry., • Strong knowledge of statistical methodologies and their application in clinical trials and health research. Working knowledge of Bayesian methodology and causal inference is preferred., • Experience with regulatory submissions and interactions with regulatory agencies., • Proficiency in statistical software (e.g., SAS, R) and data management systems., • Experience with CDSIC including SDTM, ADaM, CDASH., • Successful track record of working independently in a matrixed organization and providing solutions to emerging problems., • Excellent communication and interpersonal skills, along with organizational skills., • Ability to work collaboratively in a multidisciplinary team environment., • Experience in people management is preferred. What We Offer: • Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly., • Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits., • Unlimited PTO, • Two, one-week company-wide shutdowns each, • Commitment to provide professional development opportunities., • Remote working environment with frequent in-person meetings to address complex problems and build relationships. The expected salary range offer for this role is $275,000 to $290,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location. As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients. Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email. Please also be aware that all job postings will be listed on our website at spyre.com/careers/.

About Cleerly We’re Cleerly – a healthcare company that’s revolutionizing how heart disease is diagnosed, treated, and tracked. We were founded in 2017 by one of the world’s leading cardiologists and are a growing team of world-class engineering, operations, medical affairs, marketing, and sales leaders. We raised $223M in Series C funding in 2022 which has enabled rapid growth and continued support of our mission. In December 2024 we received an additional $106M in a Series C extension funding. Most of our teams work remotely and have access to our offices in Denver, Colorado, New, York, New York, Dallas, Texas, and Lisbon, Portugal with some roles requiring you to be on-site in a location. Cleerly has created a new standard of care for heart disease through value-based, AI-driven precision diagnostic solutions with the goal of helping prevent heart attacks. Our technology goes beyond traditional measures of heart disease by enabling comprehensive quantification and characterization of atherosclerosis, or plaque buildup, in each of the heart arteries. Cleerly’s solutions are supported by more than a decade of performing some of the world’s largest clinical trials to identify important findings beyond symptoms that increase a person’s risk of heart attacks. At Cleerly, we collaborate digitally and use a wide variety of systems. Our people use Google Workspace (GMail, Drive, Docs, Sheets, Slides), Slack, Confluence/Jira, and Zoom Video, prior experience in these areas is a plus. Role or department specific technology needs may vary and will be listed as requirements in the job description. While we are mostly a remote company, travel is required for some team meetings and cross function projects typically once per month or once per quarter, for some roles like sales or external facing roles travel could be up to 90% of the time. About the Opportunity We are seeking an accomplished Senior Product Manager to lead the release and launch of Cleerly’s AI-powered products for cardiovascular health. The Product Manager will collaborate with cross-functional teams to define product requirements, prioritize features, and deliver innovative AI solutions that directly impact the diagnostic and prognostic care pathways for heart disease. This role requires a focus on understanding clinical needs, designing effective solutions, and making informed trade-offs to balance customer demands with technical feasibility. The Product Manager will be a primary contributor to product definition and will be responsible for prioritizing and articulating new opportunities in the marketplace and defining the product roadmap in alignment with the overall business objectives. Responsibilities • Lead the product roadmap for innovation products aligning with market demand, customer needs and company goals., • Engage with internal and external stakeholders, such as clinicians and AI scientists, to shape the product vision and direction; establish the voice of the customer funnel., • Write clear business and functional requirements that support development efforts while ensuring clinical relevance and regulatory alignment., • Understand the domain of diagnostic and prognostic care pathways for heart disease to guide product decisions., • Prioritize features and balance trade-offs between performance, feasibility, and business impact., • Collaborate with AI, regulatory, and engineering teams on implementation, from design and development reviews to launch, ensuring timely and high-quality delivery., • Work closely with product management and leadership teams to develop and support the go-to-market strategy., • Define, track, and interpret key product metrics to drive future product iteration, inform decisions and drive continuous improvement., • Partner with downstream marketing and sales team on product detail and messaging and support of initial implementation of products in the field at key customer accounts. Requirements • 8+ years in product and portfolio management, with hands-on experience developing and launching SaMD, or AI-driven healthcare solutions., • Bachelor's degree in Engineering, Biomedical Engineering, or a related technical field. A Master’s or PhD degree is a plus and may substitute for part of the required experience., • Proven track record of leading the roadmap planning, end-to-end development, launch, and iteration of complex products in fast-paced or startup environments., • Deep understanding of clinical workflows and advanced imaging techniques, particularly in cardiology and radiology., • Track record of managing products through the full lifecycle, from concept to launch and beyond, while anticipating future needs and problems in the roadmap., • Strong research and analytical skills, a deep understanding of customer needs, and an ability to represent the customer as a stakeholder in detailed design team meetings., • Skilled at breaking down complex, ambiguous, or changing problems into clear product strategies and functional requirements., • Familiar with deep learning concepts, agile development methodologies (e.g., Agile, Scrum), and the regulatory environment (FDA, HIPAA, and global guidelines)., • Comfortable working cross-functionally including ML/AI, clinical, engineering, sales, regulatory, and marketing teams., • Excellent written and verbal communication skills with the ability to influence and collaborate across teams. Preferred Qualifications • Experience leading cross-functional project teams including ML/AI,imaging, clinical, engineering, sales, regulatory, and marketing teams., • Prior experience in the cardiovascular field with base knowledge of cardiovascular diseases and procedures, to be able to engage in thoughtful discussions with key stakeholders., • Comprehensive knowledge of one or more medical imaging modalities (CT, MRI, Ultrasound, Fluoroscopy, etc.) and their role in diagnostic decision making, procedure planning and guidance., • Prior experience in complex healthcare or medical imaging workflow applications and enterprise imaging IT solutions., • Track record of driving strategic ideas, building business cases, developing product roadmaps, and securing executive alignment to deliver high-impact solutions., • Knowledge of global healthcare economics, reimbursement models, and payer dynamics. TTC*: $207,000 - $241,500 *Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.). Each role at Cleerly has a defined salary range based on market data and company stage. We typically hire at the lower to mid-point of the range, with the top end reserved for internal growth and exceptional performance. Actual pay depends on factors like experience, technical depth, geographic location, and alignment with internal peers. Working at Cleerly takes HEART. Discover our Core Values: • H: Humility- be a servant leader, • E: Excellence- deliver world-changing results, • A: Accountability- do what you say; expect the same from others, • R: Remarkable- inspire & innovate with impact, • T: Teamwork- together we win Don’t meet 100 percent of the qualifications? Apply anyway and help us diversify our candidate pool and workforce. We value experience, whether gained formally or informally on the job or through other experiences. Job duties, activities and responsibilities are subject to change by our company. OUR COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER. We do not discriminate on the basis of race, color, national origin, ancestry, citizenship status, protected veteran status, religion, physical or mental disability, marital status, sex, sexual orientation, gender identity or expression, age, or any other basis protected by law, ordinance, or regulation. By submitting your application, you agree to receive SMS messages from Cleerly recruiters throughout the interview process. Message frequency may vary. Message and data rates may apply. You can STOP messaging by sending STOP and get more help by sending HELP. For more information see our Privacy Policy (___. All official emails will come from @cleerlyhealth.com email accounts. #Cleerly

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Sr. Director, Biostatistical Consulting (SrDBiosC) to join our A-team (office-based*/remote). As a (SrDBiosC) at Allucent, you are responsible for assisting in the coordination of statistical consulting services within the Biostatistics and Statistical Programming Department. This includes management of direct reports, ensuring appropriate resourcing allocation, and supporting business development and proposal needs. This position contributes to the department, the business unit, and Allucent financial and operational goals. The SrDBiosC, interacts with the BIOSC team and Allucent biostatistics and statistical programming team members, direct reports, executive leadership, other Allucent functional groups and business units. This position maintains compliance with relevant SOPs, regulatory guidelines, and client expectations. The SrDBiosC, provides statistical consulting to sponsors to support clinical program development, protocol development, sample size and endpoint selection, regulatory interactions, exploratory analyses, scientific meetings, and executive decisions. The SrDBiosC is a senior member of BIOSC and supervises according to the organizational chart. In this role your key tasks will include: • Provide statistical consulting to sponsors to support clinical program development, protocol development, sample size calculations, endpoint selection, regulatory interactions, exploratory analyses, scientific meetings, and executive decisions, • Provide statistical consulting for complex and/or novel statistical analyses, • Provide statistical consulting to support clinical development strategies, including extensive interface with client executive and leadership teams, • Provide input and support responses to regulatory questions on statistical issues relating to client regulatory submissions, interacting with and attending meetings with regulatory bodies as applicable, • Prepare statistical analysis plans (SAPs) and table, listing, and figure (TLF) mocks for any complexity of study, • Provide senior reviews of statistical documents, data, and outputs for studies of all complexities to ensure quality and integrity, • Execute a statistical analysis of any complexity as specified in a protocol or analysis plan, • Interpret and communicate results for complex statistical analyses and outputs, • Develop and/or review the statistical sections of a study protocol for studies of any complexity level, • Review statistical sections of a clinical study report to ensure accurate descriptions of statistical methods used and results of analyses, • Provide randomization materials including randomization schedules and treatment kit lists per Allucent SOPs and the sponsor-approved specifications, • Develop or review documents for integrated analyses (e.g. ISS/ISE), including integrated SAPs and statistical sections of integrated study reports, • Working knowledge of SAS® for production and validation of datasets and statistical outputs, • Write and review specifications for complex ADaM or analysis datasets · Annotate or review annotations of TLF mocks to assist programming efforts, • Working knowledge of CDISC standards, • Review CRF design to ensure it conforms with the study protocol and analysis needs, • Review data management documents as requested to ensure integrity of study data, • Lead highly complex projects by fulfilling the following responsibilities: communicate with the client and statistical team, set and achieve timelines and milestones, ensure proper execution of the study SAP, monitor programming efforts in collaboration with the lead programmer, and work with management to ensure adequate resourcing, • Function as the lead unblinded statistician for studies and manage unblinded tasks including implementation of interim analyses and participation in DMC/safety review meetings, • Accountable for leading biostatistics and programming activities for a program of studies of high complexity and/or of high value., • Identify high-risk or high-impact deliverables and assign appropriate oversight, • Lead and manage project budgets, support financial reporting for studies, identify of out-of-scope work and provide leadership in change order process, • Collaborate with and verify open communication with other functional areas and business units, • Provide biometrics leadership and coordination across client and other vendor functional areas, including clinical operations, pharmacovigilance, regulatory, and medical writing teams, • Represent Allucent at proposal bid defenses and/or marketing meetings with prospective clients, • Provide key input into project proposals and budgets, • Establish positive relationships with current and future clients, • Identify key accounts and maintain strong long-lasting relationships to win new and repeat business, • Monitor and assure client satisfaction on existing projects for biostatistics and statistical programming, • Contribute to BIOSC, BBU, and corporate marketing activities via blogs, webinars, white papers, and other publications and presentations, • Graduate degree (Master’s degree/local equivalent, or higher) in a relevant discipline including, but not limited to, statistics, mathematics, life science, epidemiology, or healthcare, • Must have strong experience in Bayesian designs specifically in oncology studies., • Minimum 15 years of relevant work experience, • Minimum 10 years of experience in drug development and/or clinical research, • Thorough knowledge of GxP, • Strong familiarity with relevant regulations and guidelines, • GDPR/HIPPA, CFR/CTR/CTD and applicable (local) regulatory requirements, • Working knowledge of computer systems, applications and operating systems, • Demonstration of critical thinking and analytic skills, • Broad knowledge of drug development, • Ability to simplify complex issues into understandable concepts, • Proficient with one or more sample size software packages, • Strong technical skills with proficiency in SAS and/or other statistical programming languages, • Strong written and verbal communication skills including good command of English language, • Collaborative and client-focused, • Ability to work in a fast-paced challenging environment of a growing company, • Administrative excellence, • Strong leadership skills, • Effective at problem solving, strategic thinking and conflict resolution, • Strong presentation and networking capabilities, • Excellent organizational, negotiating and financial skills, • Knowledge of SAS, • Proficiency with various computer applications such as Word, Excel, and PowerPoint, • Strong individual initiative, • Excellent attention to detail and commitment to quality, • Ability to establish and maintain effective working relationships with co-workers, managers, clients, and vendors, • Ability to effectively manage multiple tasks and projects, • Comprehensive benefits package per location, • Competitive salaries per location, • Departmental Study/Training Budget for furthering professional development, • Flexible Working hours (within reason), • Opportunity for remote/hybrid* working depending on location, • Leadership and mentoring opportunities, • Participation in our Buddy Program as a new or existing employee, • Internal growth opportunities and career progression, • Financially rewarding internal employee referral program, • Access to online soft-skills and technical training via GoodHabitz and internal platforms Disclaimers: *Our office-based work policy encourages a dynamic work environment, prescribing a minimum of 2 days in office per week for employees within reasonable distance from one of our ___. “The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.” #LI-Remote #LI-Hybrid #LI-TCW

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds... ClinChoice is searching for a Principal Statistical Programmer Consultant to join one of our clients. The Principal Statistical Programmer will serve as a senior technical expert responsible for end-to-end programming deliverables, study leadership, and oversight of internal teams and external vendors. This role requires advanced expertise in SAS, familiarity with R, deep knowledge of CDISC standards, and strong experience working on oncology studies and regulatory submissions. * Lead programming activities for oncology clinical trials across multiple studies. * Develop, validate, and maintain SDTM and ADaM datasets following CDISC guidelines. * Oversee production of Tables, Listings, and Figures (TLFs) for study reporting and submissions. * Provide SAS programming expertise to support complex data derivations and analyses. * Review and ensure traceability, consistency, and quality of all programming deliverables. * Act as programming lead for assigned studies, managing timelines and deliverables. * Work closely with Biostatistics, Data Management, Medical Writing, and Regulatory Affairs. * Coordinate with CROs and external vendors, ensuring compliance, quality, and adherence to Kite’s programming standards. * Support integrated analyses including ISS/ISE. * Prepare submission-ready programming outputs and documentation, including define.xml, annotated CRFs, and reviewer guides. * Ensure all programming meets regulatory requirements (FDA, EMA, PMDA). * Contribute to responses for regulatory queries and data requests. * Bachelor’s or Master’s degree in Statistics, Computer Science, Mathematics, Life Sciences, or related field. * 8–12+ years of statistical programming experience in pharma/biotech or CRO. * Expert-level proficiency in SAS. * Strong understanding of CDISC SDTM and ADaM standards. * Significant experience supporting oncology clinical trials (hematologic or solid tumors). * Experience supporting regulatory submissions and preparing submission-ready outputs. * Excellent communication skills and ability to collaborate cross-functionally. The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. #LI-TT1 #LI-Remote #Principal#Contract

This is an exciting opportunity to participate in advancing Natera’s oncology product portfolio of cutting-edge diagnostic tests. As a Senior Statistical Programmer, you will leverage your strong R programming skills and clinical trials background to contribute to the analysis and reporting of clinical trials supporting multiple regulatory submissions. PRIMARY RESPONSIBILITIES: • Primary programmer for one or more clinical validation studies supporting in vitro diagnostic submissions (e.g., IVDR, 510(k), CTA/CDx/PMA, etc.) including analysis datasets and Tables, Figures and Listing (TFL) generation., • Contribute to programming infrastructure, including R package development and maintenance., • Collaborating with statisticians, clinical teams, and data managers, • Creating and maintaining programming specifications for analysis datasets, • Performing data cleaning, transformations, and quality checks, • Perform programming validation and ensuring data integrity., • Supporting regulatory submissions by generating required analysis datasets, TLFs and documentation QUALIFICATIONS: • Bachelor’s in statistics, mathematics, computer science, or related field., • 3+ years related experience with at least 1 years experience in Clinical Trial analysis., • At least 2 years R programming experience. KNOWLEDGE, SKILLS, AND ABILITIES: • Proficient in R programming including building and maintaining packages., • Experience in analysis dataset and TFL generation., • Prior experience in NGS, genetics, and/or oncology diagnostics preferred., • Experience maintaining statistical computing environments a plus., • Experience with CDISC standard including SDTM, and ADaM is a plus $120,300 - $150,400 USD OUR OPPORTUNITY Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives. The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management. WHAT WE OFFER Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program! For more information, visit ___. Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide. All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws. If you are based in California, we encourage you to read this important information for California residents. Link: ___ Please be advised that Natera will reach out to candidates with a @___ email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes. For more information:

Clinical Project Manager II - Virology (Sponsor Dedicated/Remote) Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program., • We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life., • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job Responsibilities Are you a Clinical Project Manager who thrives in fast-paced, collaborative environments and enjoys driving complex clinical trials forward with confidence and precision? This is an exciting opportunity to join a highly supportive, mentorship-driven team focused on advancing innovative virology programs through early-phase clinical development. In this role, you will serve as a key operational leader supporting Phase I virology studies within a sponsor-dedicated environment. You'll partner cross-functionally with internal teams, vendors, and stakeholders to ensure clinical trials are executed efficiently, proactively, and with the highest level of quality. This team values collaboration, accountability, emotional intelligence, and professional growth. Leadership is highly supportive, mentorship-focused, and deeply invested in helping team members expand their skills and advance their careers. While remote/home-based candidates may be considered, priority will be given to candidates located in or near Foster City, California, with the ability to work onsite 2-3 days per week. As a Clinical Project Manager II - Virology, you will oversee operational delivery and vendor management activities for early-phase virology clinical trials. You will play a critical role in ensuring studies progress seamlessly across the full clinical trial lifecycle-from study start-up through closeout-while maintaining strong communication, organization, and cross-functional alignment. This is an ideal opportunity for a proactive clinical operations professional who enjoys ownership, problem-solving, and working with a team that genuinely values partnership and continuous development. * Lead and support operational execution of Phase I virology clinical trials within a sponsor-dedicated model * Manage and oversee vendors to ensure quality deliverables, timelines, and study expectations are consistently met * Coordinate cross-functional clinical trial activities from study start-up through closeout with minimal oversight * Drive meeting leadership by setting agendas, facilitating productive discussions, documenting decisions, and ensuring accountability for action items * Partner closely with Clinical Operations, study teams, vendors, and stakeholders to proactively identify and resolve operational challenges * Ensure effective communication across teams while maintaining professionalism and strong stakeholder relationships * Monitor study progress, timelines, risks, and operational deliverables to support successful trial execution * Contribute to a positive, collaborative team culture built on transparency, accountability, and mutual respect * Support inspection readiness and compliance with applicable SOPs, GCP, and regulatory requirements * Lead with a solutions-oriented mindset while helping align teams toward shared project goals Required Qualifications * Clinical Operations experience or related clinical trial management knowledge * Prior experience supporting or managing clinical trials within a CRO, biotech, or pharmaceutical environment * Strong vendor management and oversight experience * Understanding of the full clinical trial lifecycle and operational processes * Experience coordinating cross-functional teams and driving project execution * Strong organizational, communication, and meeting facilitation skills * Ability to work independently, prioritize effectively, and proactively navigate challenges * Professional presence with strong emotional intelligence and stakeholder management capabilities Preferred Experience * Early-phase (Phase I) clinical trial experience * Virology therapeutic area experience strongly preferred * Stable career progression demonstrating depth in clinical trial management * Experience working in sponsor-dedicated environments * Ability to lead discussions confidently in fast-paced, high-visibility settings WHAT MAKES THIS OPPORTUNITY DIFFERENT * Join a mentorship-driven leadership team that is highly supportive and invested in your long-term growth * Work within a collaborative environment where teamwork, respect, and transparency are truly valued * Gain meaningful exposure to early-phase virology studies and complex clinical development programs * Be empowered to take ownership, contribute ideas, and make a measurable impact * Enjoy the flexibility of a remote environment while maintaining close partnership with an engaged and collaborative team * Opportunity to grow your career within a high-performing clinical operations organization focused on innovation and development At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. Job Summary The Medical Science Liaison (MSL) / Senior Medical Science Liaison (Sr. MSL) is a field-facing representative of US Medical Affairs with a primary responsibility of engaging in the exchange of scientific data and other medical and/or scientific information with external customers(healthcare providers, researchers, professional organization leadership, and population-based decision makers) in the areas of Eisai's interest. The person in this position will demonstrate a thorough understanding of the customer's needs, issues and priorities as they relate to Eisai's strategic business plan. TheMSL/Sr. MSLbrings relevant insights from the field on research developments, treatment landscape and new concepts in medical treatment. The MSL/Sr. MSL will assume a leadership role by teaching, coaching and mentoring new or less experienced MSLs and by assuming responsibility for special projects as they arise. The impact that a MSL/Sr. MSL will have on the organization includes the following: a) as a representative of Eisai,theMSL/Sr. MSL will communicate key information about Eisai, the company and itshhc mission;b) provide key scientific and clinical information about Eisai's products; serve as a conduit for communication between Eisai Research and the medical community regarding ideas for future research with Eisai's products, and c) provide corporate value through demonstrated leadership and participation in strategic thinking.Essential FunctionsProduct/Therapeutic Area Support to External Stakeholders • Act as the primary clinical/scientific resource toHealthcare Providers(HCPs) in the territory for information pertaining to disease state and Eisai's product(s) to ensure awareness and understanding., • Serve as a conduit for accurate and updated clinical, scientific and medical information between Key Opinion Leaders (KOLs)/investigators and the company's Medical Affairs and development groups., • Establish, foster, cultivate and maintain peer relationships with KOLs in the therapeutic areas in which Eisai has current and future interests., • Share knowledge and participate in scientific exchanges and interactions with identified KOLs., • Present clinical, scientific and economic data on Eisai's products and relevant therapeutic areas to population-based decision-makers, as requested., • Support assigned professional congresses in accordance with MSL plan. Be prepared to lead congress coverage efforts, including coordination of all MSL/Sr. MSLactivities, as required and assigned by the management., • Identify and report key scientific, clinical and research insights from KOLs to Medical Affairs., • Develop, implement and present to management plans to support Medical Affairs strategic direction for assigned territory. Training/Education Resource • Maintain and demonstrate thorough and up-to-date knowledge of disease state, study methodology, clinical information, and product data., • Demonstrate full knowledge of and ability to execute on approved medical platforms/strategies and MSL initiatives., • Serve as technical/scientific subject matter resource to Eisai commercial personnel, if requested., • Teach, coach and mentor new or less experienced MSLs; assist with supervision/performanceevaluation;assume responsibility for special projects. Provide valuable contributions to the organization including leadership and strategic planning. Research Support • Facilitate review and follow up of submitted Investigator-InitiatedStudies(IISs) and assist with Eisai sponsored trials., • Serve as primary contact to external investigators who submit IISs. The MSL may also be involved with providing recommendations for site selection and scientific expertise to Investigators involved in company sponsored post-marketing studies. Professional Organization Support • Lead field medical efforts in support of Eisai's collaboration and interactions with professional organizations/societies&advocacy groups, as required. Educational RequirementsRequires an advanced, terminal Doctorate level (D-level) degree in medical or health sciences (e.g. MD, PhD, PharmD, DPH, EdD). Experience • For MSL 0-3years of experience in the pharma/biotech industry/clinical pharmacist/research/ related experience in a scientific or clinical setting, preferably as MSL., • For Sr. MSL, a minimum of 3 years MSL experience in Oncology/Hematology., • Strong broad-based scientific and pharmaceutical knowledge., • Clinical trial development and drug launch experience is strongly preferred., • Knowledge of treatment guidelines, clinical research processes, FDA regulations and OIG guidelines are required., • Knowledge and experience within Eisai desired therapeutic area(s) and ability to communicate with confidence and accuracy across multiple disease states., • Established relationships with key opinion leaders and knowledge of institutions in therapeutic areas of interest. Other Skills and Abilities: • Excellent presentation and teaching skills., • Strong overall written and verbal communication skills., • Demonstrated ability to assess issues and think strategically., • Demonstrated ability and experience working cross-functionally., • Demonstrated ability to anticipate, organize, plan and handle multiple changing priorities., • Demonstrated ability to work independently and not requiring close supervision while adhering to Medical Affairs strategic direction., • Ability and interest in coaching and mentoring less experienced MSLs. Ability to lead and motivate team members without a direct reporting relationship., • Ability and interest in leading and participating in projects while effectively balancing projects with field work., • Demonstrated ability to analyze complex situations and proactively identify opportunities/issues;effectivelysolve problems that cross functional boundaries., • Committed to the concept of team and working within the framework of the Medical Affairs Department and Eisai organization, including as it pertains to compliance with policies, systems and practices., • Sound computer skills including applications for word processing, producing slide materials and working with spreadsheets., • Previous established relationships with KOLs in Oncology/Hematology., • Possesses anunderstandingof the pharmaceutical corporate environment and appreciation for commercialoperations,including marketing and sales strategies., • Capable of engaging in frequent business travel (approximately 60% of time), including air travel, ability to travel overnight and occasionally on weekends., • Domestic and international travel may include spending time at cancer trial sites/institutions, conference center, offices and hotels., • Possesses and maintains a valid driver's license., • This is a field-based position. The employee is required to set up a home-based office. #LI-MI1 As a condition of employment and an essential function of this field-based position, applicants must be able to engage in person with HCPs and other third parties at their offices, institutions and other appropriate locations on a regular basis. In order to gain in-person access, applicants selected for the position may be required to complete third parties' credentialing and/or entry requirements, which often include an attestation to and/or providing proof of having received certain vaccinations. To the extent you are unable to meet certain requirements for qualifying medical (including pregnancy-related) or religious reasons, applicants must request a reasonable accommodation by contacting the Human Resources Department.Skills:Communication & Cross-functional Influence, Critical Thinking & Agility, Healthcare Environment Dynamics, KOL/ HCP Engagement, Medical Data and Insights, Mentoring, Resource Planning & Management, Territory Management (MSL) Eisai Salary Transparency Language: The annual base salary range for the Medical Science Liaison (MSL) / Senior Medical Science Liaison (Sr. MSL), Oncology - Pennsylvania / Field-based is from :$165,300-$216,900 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ___. Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

Principal Biostatistician (Biomarker Analyst -EMEA and US BASED) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program., • We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people., • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities Major tasks: * Collaborates with representatives from other functions to plan, execute and analyze all biomarker aspects (including genomics and devices) of clinical studies or biomarker studies in the role of the biomarker statistician and assumes the role of project biomarker statistician under guidance of an experienced statistician * Develops the Biomarker Evaluation Plan for the study as appropriate, ensuring overall consistency within and between projects * Facilitates the overall organization and coordination of statistical activities regarding biomarker research and development activities for specific studies and projects * Conduct and design advanced data analysis for genomics and biomarker statistics, including statistical programming, and design complex analysis algorithms. * Assumes responsibility for the production and accuracy of the Biomarker Evaluation Report with respect to statistical deliverables and interpretation of the results. * Works independently at routine and complex statistical questionsand tasks. * Develops and implements standard processes for the analysis of routine (parts of) biomarker assessments. Possible Additional Tasks: • Serves as a statistical department resource, mentors biostatisticians on job skills, and oversees or develops training plans or materials for Biostatistics associates. Conducts training sessions, or otherwise trains new hires and enhance the skills of existing personnel., • Directs the activities of other biostatistics personnel on assigned projects to ensure timely completion of high quality work. Provides independent review of project work produced by other biostatisticians in the department., • Provides support across all statistical tasks during the lifecycle of the project, from protocol to CSR., • Prepares or oversees the preparation of Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures. Collaborates with sponsor, if required., • May be responsibleas Lead Biostatistician for the statistical aspects of the protocol, generation of randomization schedule, and input to the clinical study report., • Creates or reviews programming specifications for analysis datasets, tables, listings, and figures., • Reviews SAS annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned analysis., • Implements company objectives, and creates alternative solutions to address business and operational challenges., • As biostatistics representative on project teams, interfaces with other departmental project team representatives, • Preparing in advance for internal meetings, contributing ideas, and demonstrating respect for opinions of others., • Conducts and participates in verification and quality control of project deliverables, ensuring that output meets the expected results and is consistentwith analysis described in the SAP and specifications., • May lead complex or multiple projects (e.g. submissions, integrated analyses), and attend regulatory agency meetings or responds to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor., • Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, discusses time estimates for completion of study related activities with biostatistics management, adapts to timeline or priority changes by reorganizing daily workload, and proactively communicates to biostatistics management any difficulties with meeting these timelines., • Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met. Identifies out of scope tasks and escalates to management., • Provides statistical programming support as needed., • May participate in Data Safety MonitoringBoard (DSMB) and/or Data Monitoring Committee (DMC) activities, including charter development and serving as an independent non-voting biostatistician. May serve as a voting statistician on DSMBs and/or DMCs., • Provides input and reviews, and subsequently follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH)., • Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs; ensuring inspection readiness., • Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business., • Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others, • Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings., • Performs other work-related duties as assigned., • Minimal travel may be required. Qualifications*Strong knowledge on Biomarker evaluation, esp. In Oncology, ctDNA data, relevant parameters and underlying biology • Graduate degree in biostatistics or related discipline., • Extensive experience in clinical trials or an equivalent combination of education and experience, demonstrated by the ability to lead multiple projects and programs of studies., • Proficiency in programming., • Ability to apply extensive knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research and to effectively communicate statistical concepts., • Experience across all statistical tasks required to support clinical trials during the lifecycle of the project, from protocol to CSR., • Experience with regulatory submissions preferred., • Excellent written and verbal communication skills., • Ability to read, write, speak, and understand English. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. The Senior Oncology Sales Specialist is responsible for meeting/exceeding sales goals through promoting Oncology therapeutic products within an assigned territory in a compliant and appropriate manner. The Senior Oncology Sales Specialist represents and promotes assigned brand(s) in the oral markets with approved indications, helping targeted customers, such as Medical Oncologists, Hematologists, Endocrinologists, and nurses, etc. learn about the efficacy and safety of Eisai's product(s) consistent with FDA approved label. Works with office management to provide various informational resources, such as product data, and builds appropriate relationships with key personnel. Understands managed markets to understand product access and partners with appropriate reimbursement/market access partners. Key job activities include territory and market analysis, strategic business planning, self-driven execution of plans, meeting with key stakeholders, adapting quickly to internal/external changes in business and proactively driving local solutions. Collaborates appropriately with internal cross functional partners including but not limited to Associate Director Regional Marketing, Oncology Field Reimbursement Managers, and other specialty roles to facilitate aligned, coordinated efforts with Customers in a compliant manner. Responsibilities: • Responsible for meeting/exceeding Oncology sales goals for an assigned territory by promoting Oncology therapeutic products in a compliant and appropriate manner., • Collaborate with leaders and relevant cross-functional teams to develop and implement territory business strategies anddrive pull-through sales within Integrated Delivery Networks., • Conduct ongoing territory and market analysis to monitor customer needs and preferences, and local market dynamics and trends., • Identify, build relationships with, and influence prescribers and decision-makers through understanding of issues and opportunities in territory., • Deliver clinical, efficacy, and safety messaging and information about product access / safe administration to relevant customer stakeholders in a compliant way., • Monitor operating costs and compliance with territory budget., • Seek out mentorship to learn and build key sales skills. Qualifications: Specialist- Oncology • Bachelor's degree with minimum 2+ years of relevant experience in specialty sales experience in device sales or related therapeutic area (Oncology sales experience preferred)., • Experience in hospital and large account sales, and documented history of successful sales performance in a competitive environment preferred., • Experience working with relevant customer business, disease state, product prescribing information, approved promotional clinical trials, patient access to medication, and regulatory/compliance guidelines preferred., • Experience with account planning and management preferred., • Experience working withkey laws and regulations impacting the pharmaceutical industry (e.g., PhRMA Code; Federal Food, Drug, Cosmetic Act; Anti-Kickback Statute; False Claims Act, OIG/DOJ Guidance; Foreign Corrupt Practices Act; and federal and state transparency and disclosure laws) preferred., • Demonstrated skills at building and maintaining professional relationships with key customers and others in the customer influence network, preferred., • Minimum 3+ years of relevant experience in specialty sales experience in device sales or related therapeutic area (Oncology sales experience highly preferred)., • Proven track record in successfully managing/overseeing sales portfolio within territory., • Demonstrated success in planning/revising tactics within territory to align with external trends, market opportunities, and competitor landscape., • Proven performance as a Specialist and fulfillment of defined promotion criteria. As a condition of employment and an essential function of this field-based position, applicants must be able to engage in person with HCPs and other third parties at their offices, institutions and other appropriate locations on a regular basis. In order to gain in-person access, applicants selected for the position may be required to complete third parties' credentialing and/or entry requirements, which often include an attestation to and/or providing proof of having received certain vaccinations. To the extent you are unable to meet certain requirements for qualifying medical (including pregnancy-related) or religious reasons, applicants must request a reasonable accommodation by contacting the Human Resources Department.Skills:Clinical Acumen (Oncology), Critical Thinking & Agility, Focus On Customers & Partners, Sales Ops & Data Analytics, Sells Effectively & Makes Impact, Territory/Account Management Eisai Salary Transparency Language: The annual base salary range for the Sr. Oncology Sales Specialist- S2 - (Edison, NJ) (field based) is from :$151,040-$198,200 Under current guidelines, this position is eligible to participate in : Eisai Inc. Sales Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ___. Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

Patient Engagement Lead - Global Clinical Trial Recruitment and Retention Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program., • We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life., • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job Responsibilities The Patient Engagement Lead is a senior-level role responsible for the end-to-end ownership of global patient recruitment and retention (R&R) strategy and execution across clinical trials. This is not a support function-this role is accountable for defining, operationalizing, and delivering recruitment strategy in partnership with sponsors. You will lead the day-to-day execution of global enrollment strategies, ensuring performance against timelines, budgets, and quality expectations. This role requires a candidate who can step in immediately, operate autonomously, and drive results across complex, global studies. Full Ownership of Global Recruitment Strategy * Own and lead the global patient recruitment and retention strategy across assigned studies from start-up through closeout * Translate strategy into execution by driving day-to-day delivery, performance tracking, and continuous optimization * Serve as the accountable lead for enrollment outcomes, proactively identifying risks and implementing mitigation plans Global Program Leadership * Lead global, multi-region recruitment programs, ensuring alignment across geographies, study teams, and solution partners * Operate as the central point of coordination across stakeholders to ensure seamless execution and delivery * Drive consistency and quality in strategy implementation across all regions and phases of the study Sponsor-Facing Leadership * Act as a primary point of contact for sponsors on all recruitment-related activities * Provide strategic guidance, performance insights, and clear recommendations to optimize enrollment outcomes * Lead discussions on strategy performance, risks, and innovative approaches to accelerate recruitment Vendor & Partner Oversight * Identify and lead selection of recruitment solution partners aligned to study needs and indication * Oversee vendor performance, ensuring accountability to scope, timelines, and quality standards * Resolve vendor-related challenges independently, maintaining momentum and delivery Operational Execution & Delivery * Own the development and lifecycle management of the Participant Engagement Plan (PEP) * Oversee execution of patient-facing tactics, including material development, translation, distribution, and inventory management * Ensure all deliverables meet sponsor expectations, regulatory requirements, and internal quality standards Financial & Project Accountability * Manage recruitment-related budgets, forecasts, and scope changes * Ensure financial discipline and proactively address out-of-scope activities through appropriate change processes * Provide accurate reporting, projections, and updates to support overall study success Leadership & Continuous Improvement * Mentor junior team members and provide oversight where needed * Contribute to process improvements, innovation, and departmental growth initiatives * Support business development activities, including pre-award strategy and consultation * Bachelor's degree in Life Sciences, Healthcare, or a related field * 5+ years of experience with full ownership of global patient recruitment and retention strategy and execution within clinical research * Demonstrated experience serving as the accountable lead for day-to-day delivery of recruitment strategy for sponsors * Proven track record managing global, multi-phase clinical trials (Phase I-IV) across a variety of therapeutic areas * Experience leading global programs across regions, with accountability for overall management, execution, and results * Ability to operate independently and "hit the ground running" in a fast-paced, sponsor-facing environment * Strong expertise in data-driven enrollment strategies, including performance tracking and mitigation planning * Advanced vendor management experience, including selection, oversight, and performance optimization * Demonstrated experience managing budgets, forecasting, and scope changes * Excellent communication and stakeholder management skills, with the ability to influence at all levels * Experience supporting pre-award strategy and feasibility * Background in patient advocacy and community engagement initiatives * Experience contributing to innovation in patient recruitment approaches You'll join a highly collaborative, supportive, and growth-oriented team that values ownership, innovation, and continuous development. This is an opportunity to take full accountability for global recruitment strategy while working alongside experienced leaders committed to your success and career progression! Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Dir, Epidemiology Pipeline (TA - Virology) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program., • We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people., • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities JOIN OUR TALENT NETWORK. This position is part of an ongoing talent pipeline; while there is no immediate opening, qualified candidates will be considered as opportunities become available. *Looking for SME in Virology Clinical Trials-Serves as a scientific resource for RWLP management, Company senior management, and other Functions within Company providing expertise in multiple scientific areas. *Works hand-in-hand with RWLP management, business development, and operations personnel to develop and win global business opportunities; helps to lead the development and delivery of project proposals, bid defenses, and represents capabilities presentations. *Provides overall scientific oversight of selected projects, responsible for meeting or exceeding customer expectations for timelines, budgets, quality, and overall satisfaction. *Coordinates with the project manager to oversee the scientific aspects of study start-up and ongoing study management. Leads the development of and/or peer-review essential study documents including the protocol, case report forms, statistical analysis plan, study management plans, and interim/final study reports. Facilitates scientific advisory boards for safety studies and produces scientific reports/manuscripts/abstracts/presentations. *Maintains a strong working understanding of clinical and epidemiological practice guidelines, clinical research models, protocol designs, real-world research development trends, and regulatory expectations and develops trainings for RWLP/Company organization to enhance their familiarization of epidemiologic study designs and applicable guidelines. *Responsible for the continued building of organizational capacity, improvement of scientific and operational processes and methodologies for non-traditional site management tasks (i.e., remote or central monitoring approaches, minimized regulatory document collection, etc.), integrated RWLP technology solutions including secondary database resources, and RWLP Standard Operating Procedures (SOP) development and maintenance. *Works collaboratively across the organization to help develop business opportunities in the area of post marketing safety commitments and/or risk management; develops and recommends techniques to improve productivity, increase efficiencies, cut costs, take advantage of opportunities, and maintain state-of-the-art practices. *Works to develop collegial relationships with sponsors, thought-leaders and clinical investigators. *Develops abstracts, provides podium presentations, and leads authorship of articles, manuscripts, etc. in industry and peer-reviewed journals to promote Company services. Requirements: *SME in Virology Clinical Trials *Requires graduate degree in Epidemiology, Statistics, or Public Health; (Masters; Preferred Doctorate); *Requires in-depth knowledge of and experience with a variety of study designs; familiarity with post-marketing and late phase study designs as well as relevant guidelines preferred; *Requires basic knowledge of statistical programming language(s) (e.g., SAS, R, Python); *Excellent communication, presentation, both written and spoken; *Strong personal communication and team-oriented skills; *Demonstrated leadership and technical skills. We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Job details About Us: The people of Memorial Sloan Kettering Cancer Center (MSK) are united by a singular mission: ending cancer for life. Our specialized care teams provide personalized, compassionate, expert care to patients of all ages. Informed by basic research done at our Sloan Kettering Institute, scientists across MSK collaborate to conduct innovative translational and clinical research that is driving a revolution in our understanding of cancer as a disease and improving the ability to prevent, diagnose, and treat it. MSK is dedicated to training the next generation of scientists and clinicians, who go on to pursueour missionat MSK and around the globe. Role Overview: • Manage the day-to-day operations of a large, federally funded randomized clinical trial investigating an AI-assisted music therapy intervention for anxiety in patients living with advanced cancer, • Work collaboratively in an interdisciplinary research team comprised of music therapists, oncologists, psychologists, biostatisticians, machine learning engineers, software developers, and integrative medicine specialists., • Conduct quantitative, qualitative, and mixed methods analyses of datasets in collaboration with the biostatistics team., • Doctoral degree (PhD, MD, PsyD, or equivalent) with a research focus in clinical psychology, palliative care, oncology, music therapy, or an oncology-related field, • Hands-on experience with clinical research, including IRB protocols, data management, and patient-facing procedures; prior involvement in randomized clinical trials is strongly preferred., • Strong organizational and project management skills, including the ability to break multi-phase research projects into structured timelines and execute deliverables independently on time., • Methodical, detail-oriented approach to research operations, including data management systems, regulatory documentation, and compliance tracking., • Proficiency in quantitative research methods and statistical software (e.g., R, SAS, SPSS, or similar)., • Demonstrated intellectual curiosity and commitment to cross-disciplinary learning, • Strong written and oral communication skills Application Requirements Submit the following in your application: • Curriculum vitae, • One-page cover letter addressing: (a) your research background and how it aligns with this position; and (b) your career goals and what draws you specifically to the intersection of music, technology, and cancer care., • One writing sample (e.g., published article, dissertation chapter, or research report), • Three letters of recommendation, including one from a current or recent research mentor or thesis/dissertation supervisor, submitted directly by referees to ___ Pay Range: $72,000 - $87,641 Additional Detail about Dept of Medicine MSK's Integrative Medicine and Wellness Service is home to a world-class research program whose practice-changing work has been cited in clinical guidelines from ASCO and NCCN. You will work on the first randomized clinical trial to evaluate an AI-assisted music therapy intervention for anxiety in people with advanced cancer, helping to advance novel applications of AI technology in integrative oncology. With dedicated mentorship from clinician-scientists with a track record of NIH funding and publication in top-tier journals, you will be well-positioned for a successful research career. Pay Range: $0.00 - $10,000,000.00 FSLA Status: Exempt Closing: At MSK, we believe in fair, competitive pay that reflects your job, experience, and skills. MSK is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sexual orientation, national origin, age, religion, creed, disability, veteran status or any other factor which cannot lawfully be used as a basis for an employment decision. Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.

Description You're driven, resourceful, and above all else - remarkably smart. In this role, you'll join the R&D Advisory Group within Syneos Health Consulting, where you will help make life science R&D organizations and operations more efficient and effective across research, clinical, regulatory, quality and pharmacovigilance. You will help organizations in times of change, whether that is driven by a change in operating model, strategy, processes, technology, or a combination of these. You will: • Work with senior customer stakeholders to comprehend the customer's business goals, processes, operations and expectations, • Develop customer proposals, demonstrating a clear understanding of the needs and objectives, approach and solution, plus the commercial construct to deliver projects, • Develop engagement strategies and plans, and present findings and recommendations to team members, • Conduct quality management oversight of project deliverables to ensure that content aligns to the customer's business objectives and expectations, • Develop content to leverage in business development opportunities with prospective customers, • Bachelor's degree in life science or business, • Extensive experience in consulting management in the life sciences, pharmaceutical/biotech consulting industry, or equivalent industry role, • Experience working with one or more R&D operational roles either in industry or consulting, • Engagement management experience, • Master's degree in life sciences or business, • Experience in Regulatory processes, operations and technology, Registration Information Management (RIM) and the implementation/business implications of RIM Suites (e.g., Veeva Vault), • Experience of the organizational impact of other significant regulations (e.g., IDMP, EU CTR) At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. If your past experience doesn't align perfectly, we encourage you to apply anyway. At times, we will consider transferable skills from previous roles. We also encourage you to join our ___ to stay connected to additional career opportunities. Why Syneos Health? Here, you're a part of the big picture. You will collaborate with colleagues across clinical and commercial disciplines to guide premarket development through post-market commercial strategy. Every project is a chance to solve a new challenge, learn from your colleagues, and advance your career. The diversification and breadth of our new and existing partnerships create a multitude of career paths and employment opportunities. Join our game-changing, global company dedicated to creating better, smarter, faster ways to get biopharmaceutical therapies to patients. Experience the thrill of knowing that your everyday efforts are contributing to improving patients' lives around the world. Work Here Matters Everywhere | How are you inspired to change lives? Syneos Health companies are affirmative action/equal opportunity employers (Minorities/Females/Veterans/Disabled) Syneos Health has a voluntary COVID-19 vaccination policy. We strongly encourage all employees to be fully vaccinated. Additionally, certain local governments or Syneos Health customers may have vaccine requirements that apply to some of our employees. These employees are required to submit proof of vaccination to Syneos Health and maintain compliance with these requirements. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position will include a competitive compensation package, Health benefits to include Medical, Dental and Vision, Company match 401k, flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos Health complies with all applicable federal, state, and municipal paid sick time requirements.

Dir, Epidemiology Pipeline (TA-Immunology) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program., • We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people., • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities JOIN OUR TALENT NETWORK. This position is part of an ongoing talent pipeline; while there is no immediate opening, qualified candidates will be considered as opportunities become available. *Looking for SME in Immunology Clinical Trials-Serves as a scientific resource for RWLP management, Company senior management, and other Functions within Company providing expertise in multiple scientific areas. *Works hand-in-hand with RWLP management, business development, and operations personnel to develop and win global business opportunities; helps to lead the development and delivery of project proposals, bid defenses, and represents capabilities presentations. *Provides overall scientific oversight of selected projects, responsible for meeting or exceeding customer expectations for timelines, budgets, quality, and overall satisfaction. *Coordinates with the project manager to oversee the scientific aspects of study start-up and ongoing study management. Leads the development of and/or peer-review essential study documents including the protocol, case report forms, statistical analysis plan, study management plans, and interim/final study reports. Facilitates scientific advisory boards for safety studies and produces scientific reports/manuscripts/abstracts/presentations. *Maintains a strong working understanding of clinical and epidemiological practice guidelines, clinical research models, protocol designs, real-world research development trends, and regulatory expectations and develops trainings for RWLP/Company organization to enhance their familiarization of epidemiologic study designs and applicable guidelines. *Responsible for the continued building of organizational capacity, improvement of scientific and operational processes and methodologies for non-traditional site management tasks (i.e., remote or central monitoring approaches, minimized regulatory document collection, etc.), integrated RWLP technology solutions including secondary database resources, and RWLP Standard Operating Procedures (SOP) development and maintenance. *Works collaboratively across the organization to help develop business opportunities in the area of post marketing safety commitments and/or risk management; develops and recommends techniques to improve productivity, increase efficiencies, cut costs, take advantage of opportunities, and maintain state-of-the-art practices. *Works to develop collegial relationships with sponsors, thought-leaders and clinical investigators. *Develops abstracts, provides podium presentations, and leads authorship of articles, manuscripts, etc. in industry and peer-reviewed journals to promote Company services. Requirements: *SME in Immunology Clinical Trials *Requires graduate degree in Epidemiology, Statistics, or Public Health; (Masters; Preferred Doctorate); *Requires in-depth knowledge of and experience with a variety of study designs; familiarity with post-marketing and late phase study designs as well as relevant guidelines preferred; *Requires basic knowledge of statistical programming language(s) (e.g., SAS, R, Python); *Excellent communication, presentation, both written and spoken; *Strong personal communication and team-oriented skills; *Demonstrated leadership and technical skills. We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. The Senior Medical Information Manager is responsible for contributing to the development and implementation of the Medical Information component of the strategic plan for their assigned therapeutic area. In addition, the Senior Medical Information Manager leads cross functional teams and initiatives to support Medical Affairs and business objectives. Responsibilities:* Respond to unsolicited medical inquiries from healthcare professionals, patients/consumers, field staff and other internal business partners.* Develop and manage tactical execution of the Medical Information plan for their assigned therapeutic area.* Utilize scientific expertise to lead the development and maintenance of medical information resources for assigned products to meet the needs of external customers and internal business partners.* Conduct detailed analyses of scientific literature to communicate relevant scientific information and competitive issues with Medical Affairs colleagues, cross-functionally and globally.* Implement Medical Information component of strategic medical plans for assigned products, including implementing performance improvement activities, service quality monitoring, and tracking and reporting of metrics.* Serve as POC for medical and scientific review of promotional and scientific exchange materials in CRC and MRC in collaboration and partnership with Medical Directors.* Provide inputs to the overall development of budget and resources and escalate deviations, as needed.* Analyze metrics and develop insights reports on Medical Information activities presented to internal stakeholders.* Provide scientific support for assigned stakeholders on ad hoc projects and/or initiatives, including at Medical Information Booths for assigned medical conferences.* Provide supervisory guidance, training to new hires/ less experienced colleagues and/or mentorship to pharmacy students. Qualifications:* Advanced degree in sciences or related field with 8+ years of experience in the pharma/ biotech industry.* OR a combination of equivalent education and experience.* Advanced knowledge of U.S. regulatory standards related to pharmaceutical manufacturers' communications and dissemination of medical information.* Knowledge of clinical trials, drug approval processes, and clinical application of drug products.* Prior experience in medical writing and development of scientific communication materials.* Some experience coaching and mentoring new hires/ less experienced colleagues.* Proficiency with Microsoft Office Suite software, Sharepoint, Veeva, customer relationship management software and other technology and telephony systems.* Proven performance in earlier role.* Able to travel as needed (approximately 20% on average)* Hybrid, onsite in Nutley NJ, 3 days a week (Tuesday, Wednesday and Thursday) Skills:Communication & Cross-functional Influence, Critical Thinking & Business Agility, Healthcare Environment Dynamics, Inquiry Resolution, Literature Evaluation, Medical Information Writing Skills, Medical Review, Mentoring/ People Development, Resource Planning & Management Eisai Salary Transparency Language: The annual base salary range for the Senior Manager, Medical Information, Oncology is from :$133,400-$175,100 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ___. Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

Experienced Clinical Trial Manager - Full-Service Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program., • We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life., • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job Responsibilities • Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity. Oversees site interactions post activation through site closeout. This may include patient recruitment, investigator payments or other related activities. May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT)., • Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/CeMs) is aware of the contractual obligations and parameters. Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables. Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope., • Employs strategic thinking and problem-solving skills to propose and implement risk mitigations. Participates and presents in key meetings such as Kick Off Meeting., • Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members. This may include accompanying CRA team members to sites for observation or conflict resolution., • Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines. Reviews and provides feedback on other functional plans (e.g. Data Management Plan, Communication Plan) as they relate to the clinical trial management activities., • Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan. Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team, including overseeing user acceptance testing (UAT) as needed. Ensures access and audit trail reviews are conducted as required., • Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study., • Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality. Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and / or tracking tools., • Reviews the project oversight dashboards and other clinical trial systems (e.g. Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs), Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), to oversee site and patient activities, study team conduct and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency) according to plan., • Understands the monitoring strategy required for the study and, where required, participates in the development of the study risk assessment plan. Is accountable for their assigned clinical team members' understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans., • Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports and pertinent correspondence), to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety or data integrity. Document requested revisions and approvals in CTMS. Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines., • Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables. Provides status updates on the clinical deliverables and risks to clients, project management and leadership as per departmental or study agreements. Provides solutions for obstacles in protocol execution and site management., • Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations This may include data management, study start up, patient recruitment, medical monitoring, pharmacovigilance and Quality Assurance (QA). Supports Inspection Readiness for clinical trial management scope., • Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance, CMP compliance, and identifies emerging risks. Develop and support execution of corrective action plans at site and study level. Supports and completes activities to achieve data cut and lock deadlines., • Provides feedback to line managers on staff performance including strengths as well as areas for development., • May be assigned to larger, more complex trials or may coordinate clinical activities for a team of CTMs across a portfolio of projects, • May coach and mentor CTMs regarding functional clinical delivery, evaluation of project risks, and action implementation. Qualifications: • Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience, • Demonstrated ability to lead and align teams in the achievement of project milestones, • Demonstrated capability of working in an international environment., • Demonstrated expertise in site management and monitoring (clinical or central), • Preferred experience with risk-based monitoring, • Demonstrates understanding of clinical trial management financial principles and budget management, • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements, • Must demonstrate good computer skills, • Strong conflict resolution skills, • Demonstrated ability to apply problem solving techniques to resolve complex issues and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project., • Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues, • Moderate travel may be required, approximately 20% At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: $114,000.00 - $210,900.00 The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Job Description Job Description: Assistant Building Manager, Euclid ORGANIZATION: The West Side Federation for Senior and Supportive Housing, Inc. (WSFSSH) is a community-based organization whose mission is to provide safe, affordable housing with supportive services within a residential setting, which enhances the independence and dignity of each person. WSFSSH develops, manages, and provides housing for low- income older persons, many of whom live with mental illness and/or have experienced homelessness. WSFSSH is an Equal Opportunity Employer (EOE) POSITION: Under the supervision of the Building Director and associate director/clinical coordinator, The Assistant Building Manager will assist in all aspects of the administration and property management of the building, with the goal of enabling residents to live permanently and as safely and independently as possible. WORK CATEGORIES & DUTIES Specific duties include, but are not limited to, the following: Responsibilities: Personnel • Supervise front desk personnel., • Ensure that 24hour shifts are covered as per union contract., • Maintain all leave time requests., • Ensure that all supplies including forms are maintained., • Ensure that personnel is cleaning and maintaining front desk area., • Co-Supervise maintenance staff, and administrative staff., • Assist manager in maintaining active personnel files: Vacation requests, time taken (sick leave, personal days, etc.), • Process timesheets and submit in a timely manner., • Assist Manager with staff meetings, tenant / staff complaints and performance evaluations when needed., • Responsible for taking and maintaining minutes of all meetings., • Assist Manager with Social Service staff interface., • Coordinate with social service staff on various tenant issues including arrears, housekeeping, disruptive behavior, room maintenance, monthly tenant meetings, etc., • Ensure social services department receives copies of all incident reports, tenant lists and management letters to individual residents., • Act as liaison between tenants and staff in building manager’s absence., • Assist Manager with Housing Court Hearings/Trials, • Office/Building Management and Administrative:, • Manage general office functions., • Establish a 1:1 professional relationship with tenants., • Assist manager in responding to building violations and coordinate with Contractors and Euclid Hall staff to clear violations., • Maintenance and distribution of all management office lists related to tenants, vendors, staff and miscellaneous documents., • Preparation and distribution of exterminator list to Front Desk., • Ordering supplies when needed: key blanks, appliance parts, office, cleaning and maintenance equipment., • Document vendor repair work., • Maintain related contract files., • Document problems encountered, & proposed resolutions., • Monitor vendor files., • Maintain Certificates Book / Log. Must ensure all inspection certificates and equipment inspections are current and have not expired., • Lease., • Section 8 and other income certifications., • Incident reports., • Legal correspondence., • Arrears, • DHCR, • Rent Rolls, • Legal, • Front Desk, • Assist manager and Superintendent with the general maintenance function of the premises including but not limited to the following:, • Tenant room inspections, • Daily, weekly, monthly, yearly checklists of maintenance task for use by maintenance staff., • Conduct regular inspection of boiler, elevator, fuel storage tanks (If applicable), sprinkler, standpipes, etc., • Maintaining clear identification of all building systems; for example, plumbing valves, sprinkler standpipes, etc., • Enforce recycling and garbage regulations., • Ensure Extermination List is maintained and updated monthly and Contracts are following contract agreements., • Keep orderly and stock maintenance supplies., • Rent Collection / Arrears and Payroll Distribution:, • Assist manager with rent collection and arrears pursuit., • Process coin exchanges for rent collection., • Pickup coin exchange and assist in verifying amounts received., • Make bank deposits weekly or as needed., • Distribute employee checks., • Collect all rent checks and money orders from rent deposit box and process., • Purchases:, • Request quotes for purchases using authorized vendors., • Inspect deliveries., • Review and process invoices for payment., • Other responsibilities may include:, • Working as a member of a team to establish and maintain high levels of care, respect for, and communication with tenants and staff., • Working cooperatively with other staff members., • Attending training sessions and conferences as required for enhancement of job skills., • Implementing emergency procedures as necessary., • At least 21 years of age., • Strong communication skills, math skills and computer literacy, including Microsoft Word, Excel and Outlook., • Emotionally, mentally, and physically able to perform job responsibilities., • Prefer a minimum of two years of experience working with senior adults., • Prefer Associate’s or Bachelor’s Degree., • Must be able to speak, read and write in English and Spanish. 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At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer's disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you. The Medical Science Liaison (MSL or Sr. MSL) is a field-facing representative of US Medical Affairs with a primary responsibility of engaging in the exchange of scientific data and other medical and/or scientific information with KOLs/HCPs, researchers, pharmacists, and decision makers in the areas of Eisai's interest. The person in this position will demonstrate a thorough understanding of Alzheimer's disease (AD), including the needs, issues and priorities as they relate to Eisai's strategic medical plan. MSLs will be trained and certified on AD and Eisai's dementia pipeline data in order to fulfill educational gaps with KOLs/HCPs and gather medical insights to refine medical strategy and continue to close the gap on unmet educational needs for AD HCPs. MSLs also assume responsibility for special internal/external projects as they arise. The impact that a MSL will have on the organization includes the following: a) as a representative of Eisai, a MSL will communicate key information about Eisai, the company and its hhc mission; b) provide key scientific and clinical information about Eisai's products/pipeline; serve as a conduit for communication between Eisai Research and the medical community regarding ideas for future research, and c) provide corporate value through demonstrated leadership, teamwork, participation in strategic thinking, and special projects ESSENTIAL FUNCTIONS:\ Product/Therapeutic Area Support to Stakeholders • Act as the primary clinical/scientific resource to HCPs in the territory for information pertaining to disease state and Eisai's product(s) to ensure awareness and understanding., • Serve as a conduit for accurate and updated clinical, scientific and medical information between Key Opinion Leaders (KOLs)/investigators and the company's Medical Affairs and development groups., • Establish, foster, cultivate and maintain peer relationships with KOLs in AD and dementia in which Eisai has current and future interests., • Present clinical and scientific data on Eisai's products and relevant therapeutic areas, as requested., • Support assigned professional congresses in accordance with MSL plan. Be prepared to lead congress coverage efforts, including coordination of all MSL activities., • Identify and report key scientific, clinical and research insights from KOLs to Medical Affairs. Training/Education Resource • Maintain and demonstrate thorough and up-to-date knowledge of disease state, study methodology, clinical information, and product data, • Demonstrate full knowledge of and ability to execute on approved medical platforms/strategies and MSL initiatives, • Serve as technical/scientific subject matter resource to Eisai cross functional partners, • Teach, coach and mentor new or less experienced MSLs; assist with supervision/performanceevaluation; assume responsibility for special projects. Provide valuable contributions to the organization including leadership and strategic planning., • Ability to lead and motivate team members without a direct reporting relationship Research Support • Facilitate review and follow up of submitted Investigator-InitiatedStudies (IISs) and assist with Eisai sponsored trials., • The MSL may also be involved with providing recommendations for site selection and scientific expertise to Investigators involved in company sponsored studies. REQUIREMENTS: Educational Requirements: Advanced terminal D degree in medical or health sciences (e.g MD/DO, PhD, PharmD) Experience: • 2-3 years MSL experience in neurology or complex disease states; prior dementia or AD research experience strongly preferred, 3 yrs+ required for Sr MSL title, • Established relationships with KOLs in neurology, and knowledge of institutions focused on AD preferred, • 3-5 years industry/ clinical research/ related experience in a scientific or clinical setting., • Strong broad-based scientific and pharmaceutical knowledge, • Clinical trial development and drug launch experience is strongly preferred, • Knowledge of treatment guidelines, clinical research processes, FDA regulations, pharma regulations/compliantpractices, and OIG guidelines are required., • Knowledge and experience within AD and ability to communicate with confidence and accuracy across multiple dementia disease states. Other Skills and Abilities: • Interested and skilled in communicating complex data sets and the ability to be seen as a scientific peer while educating top KOLs., • Committed to the concept of team and working within the framework of the Medical Affairs, • Strong overall written and verbal communication skills. Keen understanding of your audience and ability to tailor information appropriately., • Highly skilled in the art of strategic conversation along with a demonstrated ability to assess issues, as they arise and adapt appropriately., • Demonstrated ability to anticipate, organize, plan and handle multiple priorities, while adapting to the needs of the company and KOLs., • Has an ability to work independently and not require close supervision while adhering to compliance/regulatorypolicies., • Interest in leading and participating in projects while effectively balancing field work., • Demonstrated ability to proactively identify opportunities/challenges,willingness to communicate these challenges to leadership while working together to overcome them., • Seamlessly adapts to field situations and effectively problem solves within your territory, • Experience working in matrix environment including cross-functional commercial partners, with an understanding of the pharmaceutical corporate environment and appreciation for Commercial Operations, including Marketing and Sales strategies, • Sound computer/technology skills including applications for word processing, producing slide materials, working with spreadsheets, and video conferencing, • Possesses and maintains a valid driver's license and clean driving record., • Capable of engaging in frequent business travel (approximately 60% of time), including air travel, ability to travel overnight and occasionally on weekends., • This is a field-based position. The employee is required to set up a home-based office within their defined territory. Salary range for MSL is $144,300.00 - $189,400 USD Annual Salary range for Sr. MSL is $160,100.00 - $210,100 USD Annual #LI-MI1 As a condition of employment and an essential function of this field-based position, applicants must be able to engage in person with HCPs and other third parties at their offices, institutions and other appropriate locations on a regular basis. In order to gain in-person access, applicants selected for the position may be required to complete third parties' credentialing and/or entry requirements, which often include an attestation to and/or providing proof of having received certain vaccinations. To the extent you are unable to meet certain requirements for qualifying medical (including pregnancy-related) or religious reasons, applicants must request a reasonable accommodation by contacting the Human Resources Department.Skills:Communication & Cross-functional Influence, Critical Thinking & Agility, Healthcare Environment Dynamics, KOL/ HCP Engagement, Medical Data and Insights, Mentoring, Resource Planning & Management, Territory Management (MSL) Eisai Salary Transparency Language: The annual base salary range for the MSL/Sr. MSL, Neurology - Alzheimer's Disease, Southern Ohio- Field based is from :$165,300-$216,900 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit ___. Certain other benefits may be available for this position, please discuss any questions with your recruiter. Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans. Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:

Lantheus (NASDAQ: LNTH) is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Sweden, Switzerland and United Kingdom, Lantheus has been providing radiopharmaceutical solutions for nearly 70 years. Today, we're expanding our portfolio and pipeline across oncology, neurology and cardiology. Through recent acquisitions, along with strategic partnerships across the life sciences ecosystem, we are accelerating our efforts to advance precision medicine and improve patient outcomes around the world. At Lantheus we are purpose-driven, and every employee plays a vital role in our success. We're dedicated to cultivating a high-growth, forward-thinking culture where innovation thrives and diverse perspectives drive meaningful progress. Join us and be part of a company where your contributions make a real impact, because we know someone's health is in our hands. Summary of role The Radiopharmaceutical Clinical Applications Associate Director will be responsible for leading the clinical application efforts regionally for our radiopharmaceutical products. This role involves building and maintaining relationships with Key Opinion Leaders (KOLs) and Healthcare Providers (HCPs), providing advanced clinical and technical expertise, and ensuring the optimal use of our products in the clinical setting. The position will also support field research initiatives, provide educational training, and ensure compliance with industry regulations and company policies. This is a remote position open to applicants authorized to work for any employer within the United States. The territory includes MA, NY City, CT, RI, NH, ME, VT. Responsibilities • Identify, develop, and engage in long-term relationships with Key Opinion Leaders (KOLs) and Healthcare Providers (HCPs) in the assigned territory, including Nuclear Medicine Physicians, Radiologists, Radiation Oncologists, Technologists, Safety Officers, Health Physicists, Nursing Staff, and Advanced Practice HCPs at imaging facilities and medical centers., • Provide training to imaging/treatment centers on handling, administration, and radiation safety of current products, including initial and re-training sessions., • Educate on-site preparation and infusion processes for products, including radiopharmaceutical licensing, supporting approved imaging/therapies, and clinical trials., • Educate the HCP community to ensure they have the proper knowledge and technical expertise to use Lantheus products safely and effectively., • Utilize clinical and technical expertise to institutional workflows, regional diagnostic imaging patterns, treatment guidelines, and therapeutic advances in oncology and molecular imaging. Gather insights into the needs and interests of healthcare providers and the medical needs of patients with a focus on Lantheus approved and investigational agents., • Maintain thorough and up-to-date knowledge of imaging techniques, clinical information, and product data in the diagnostic and therapeutic radiopharmaceutical field., • Respond appropriately and document accurate scientific data in response to unsolicited questions from customers about approved and investigational products., • Support Lantheus Field Research Initiatives, including Investigator Sponsored Trials (ISTs), the Image Library, and Clinical Trials aligned with the Lantheus pipeline., • Attend national congresses and meetings, providing medical and scientific booth support as requested, in compliance with industry regulations., • Fully understand and comply with all Lantheus SOPs, working procedures, and corporate requirements., • Minimum Bachelor's Degree Required, • 4+ years Nuclear Medicine Technologist, Clinical Application Specialist, or similar/relevant experience., • 2+ years Clinical experience in oncology, urology, neurology or radiopharmaceuticals/medical imaging, • Exceptional communicator and presenter with proven oral and written communications skills., • Advanced understanding of current and emerging trends in the field of Nuclear Medicine, radiopharmaceuticals, and diagnostic imaging., • Proficient at translating and communicating approved scientific or clinical data into high quality medical information appropriate to the audiences engaged., • Demonstrated success working in a team environment, communicating clearly and effectively with management, peers, and all cross-functional teams., • Highly motivated to achieve optimal results with a demonstrated record of career growth and achievement., • Advanced Word, PowerPoint, and Excel skills The ideal candidate will embody Lantheus core values: • Let people be their best, • Respect one another and act as one, • Learn, adapt, and win, • Know someone's health is in our hands Actual base pay offered may vary depending on a number of factors such as job-related knowledge, skills and experience. Employees in this position are eligible for a discretionary performance-based cash incentive, and depending on the level of the role may be eligible for a discretionary annual equity award. Benefits for this position include a comprehensive health benefits package that includes medical, prescription drug, dental, and vision coverage. Other offerings include life and disability benefits, pre-tax accounts, a 401(k) with company contribution, and a variety of other benefits. In addition, employees are eligible for a generous time off package including paid vacation, holidays, sick days, and paid parental leave. Interested candidates can apply at Lantheus.com. Applications for this position will be accepted until May 10, 2026. Lantheus is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, disability, protected medical condition as defined by applicable state or local law, genetic information, or any characteristic protected under applicable federal, state, or local laws and ordinances. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at ___. Lantheus is an E-Verify Employer. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the ___ notice from the Department of Labor.

Dir, Epidemiology Pipeline (TA-Oncology) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program., • We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people., • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities JOIN OUR TALENT NETWORK. This position is part of an ongoing talent pipeline; while there is no immediate opening, qualified candidates will be considered as opportunities become available. *Looking for SME in Oncology Clinical Trials-Serves as a scientific resource for RWLP management, Company senior management, and other Functions within Company providing expertise in multiple scientific areas. *Works hand-in-hand with RWLP management, business development, and operations personnel to develop and win global business opportunities; helps to lead the development and delivery of project proposals, bid defenses, and represents capabilities presentations. *Provides overall scientific oversight of selected projects, responsible for meeting or exceeding customer expectations for timelines, budgets, quality, and overall satisfaction. *Coordinates with the project manager to oversee the scientific aspects of study start-up and ongoing study management. Leads the development of and/or peer-review essential study documents including the protocol, case report forms, statistical analysis plan, study management plans, and interim/final study reports. Facilitates scientific advisory boards for safety studies and produces scientific reports/manuscripts/abstracts/presentations. *Maintains a strong working understanding of clinical and epidemiological practice guidelines, clinical research models, protocol designs, real-world research development trends, and regulatory expectations and develops trainings for RWLP/Company organization to enhance their familiarization of epidemiologic study designs and applicable guidelines. *Responsible for the continued building of organizational capacity, improvement of scientific and operational processes and methodologies for non-traditional site management tasks (i.e., remote or central monitoring approaches, minimized regulatory document collection, etc.), integrated RWLP technology solutions including secondary database resources, and RWLP Standard Operating Procedures (SOP) development and maintenance. *Works collaboratively across the organization to help develop business opportunities in the area of post marketing safety commitments and/or risk management; develops and recommends techniques to improve productivity, increase efficiencies, cut costs, take advantage of opportunities, and maintain state-of-the-art practices. *Works to develop collegial relationships with sponsors, thought-leaders and clinical investigators. *Develops abstracts, provides podium presentations, and leads authorship of articles, manuscripts, etc. in industry and peer-reviewed journals to promote Company services. Requirements: *SME in Oncology Clinical Trials *Requires graduate degree in Epidemiology, Statistics, or Public Health; (Masters; Preferred Doctorate); *Requires in-depth knowledge of and experience with a variety of study designs; familiarity with post-marketing and late phase study designs as well as relevant guidelines preferred; *Requires basic knowledge of statistical programming language(s) (e.g., SAS, R, Python); *Excellent communication, presentation, both written and spoken; *Strong personal communication and team-oriented skills; *Demonstrated leadership and technical skills. We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Northwell Health, a leader in innovative healthcare, seeks a distinguished pathologist who will serve as Vice Chair of Laboratory Medicine as well as a proactive Medical Director for our Core Laboratory. Join us in shaping the future of diagnostic laboratory services at one of the largest health systems in the nation. This key leadership position involves recruitment and mentoring of faculty, strategic planning, operational oversight, and ensuring excellence in patient care through innovative laboratory practices. The ideal candidate will be a board-certified pathologist with at least 10 years of progressive clinical and leadership experience. The integrated service line for Pathology and Laboratory Medicine of Northwell Health is a 21-hospital system with a centralized core laboratory and a microbiology core serving the greater New York metropolitan area as well as Health and Hospitals corporation. Northwell Health Labs, with its centralized core laboratory, a microbiology core, and over 60 hospital and outpatient locations, provides outstanding diagnostic care to our patients. Our pathologists and PhD scientists study the causes, processes and diagnosis of diseases, with laboratory services touching every department within the health system. Our experts perform more than 25 million tests per year, from general testing to specialized testing in complex microbiology, endocrinology, cytogenetics, molecular genetics, cytology, hematology, immunology, special coagulation, and transfusion medicine. The Department of Pathology and Laboratory Medicine service line has a mission to sub-specialize anatomic pathology and laboratory medicine. In laboratory medicine, this includes 20 MD and PhD members in areas of microbiology, hematology, coagulation, clinical chemistry, flow cytometry, cytogenetics, point of care, informatics, and molecular genetic pathology. In addition, the community hospitals in the system that support rapid response laboratories are part of the integrated laboratory services. The department is home to Pathology Residency Training Programs for thirty-two pathology residents (predominantly AP/CP track) and seven subspecialty fellowships. Academic appointments are at the Zucker School of Medicine at Hofstra University. Key Responsibilities: * Contribute to enhancing the overall patient care experience through the integration of laboratory services. * Mentor and guide department faculty in professional growth and development. * Lead a team of skilled laboratory professionals, fostering a culture of continuous improvement and collaboration. * Assist the Chair with departmental management, strategic initiatives, and policy development. * Oversee all Core Lab operations to ensure high-quality diagnostic services and compliance with regulatory standards. * Implement new technologies and methodologies for efficient laboratory processes. * Collaborate with clinical teams to optimize laboratory resource utilization and enhance patient care. * Drive academic and research endeavors within the division; support scholarly activities among faculty and staff. Qualifications: * MD, MD/PhD, or equivalent degrees, with board certification in Clinical Pathology or both Clinical and Anatomic Pathology. Candidates with clinical experience in Clinical Chemistry and/or Molecular Pathology preferred. * Proven experience in laboratory leadership and management is essential. * Strong academic achievement and leadership track record in a hospital/academic setting or comparable commercial laboratory. * Excellent interpersonal and communication skills for effective team collaboration and patient interaction. * Commitment to advancing laboratory science through innovation and research. Why Northwell Health? Northwell Health is New York States largest health care provider and private employer, with 28 hospitals, 850+ outpatient facilities, and more than 16,600 affiliated physicians. We care for over two million people annually in the New York metro area and beyond, thanks to philanthropic support from our communities. Our more than 100,000 employees 18,900 nurses and 4,900 employed doctors, including members of Northwell Health Physician Partners are working to change health care for the better. Were making breakthroughs in medicine at the Feinstein Institutes for Medical Research and training the next generation of medical professionals at the visionary Donald and Barbara Zucker School of Medicine at Hofstra/Northwell. Our professionals are relentless about staying ahead of the latest clinical trials and research, partnering with our own Feinstein Institute and other world-renowned institutions. Northwell Health offers a competitive salary and benefits package. In addition, an academic appointment with The Zucker School of Medicine at Hofstra/Northwell is commensurate with credentials and experience. Physicians will be employed as members of Northwell Physician Partners, the fifth largest medical group in the country. For additional information and to apply, please forward a current CV to: Matthew Faber Director of Executive Search Office of Physician Recruitment ___ / Cell: 516-913-0337 Northwell Health is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Join us at Northwell Health and contribute to transforming the landscape of laboratory medicine. Apply today!

A global clinical research provider is seeking experienced Clinical Data Management Leads to oversee data management delivery for global clinical trials. This fully remote position involves leading cross-functional teams and ensuring compliance. Candidates should have a bachelor’s degree and at le

The Department of Dermatology at the Icahn School of Medicine at Mount Sinai in New York City, that has the largest residency program in the country and is one of the largest and best departments in the US, is seeking academic, board certified medical and cosmetic dermatologists with a strong academic track record and/or academic productivity and publications to join its growing faculty. We are particularly interested in a senior dermatologist and in a junior dermatologist with interest and expertise in skin of color, as director and associate director of the skin of color center, respectively, based on experience and academic level. This is a unique opportunity for the right candidates, given that our department is a leader in clinical and translational research in skin of color to develop the skin of color center into the leading skin of color center in the US and beyond. The successful candidates will be joining our 27 faculty members, and will be offered a highly supportive environment. The qualified candidates are expected to provide medical and/or cosmetic dermatology services and to develop clinical, translational and/or basic research involving conditions related to skin of color (such as keloids, vitiligo, CCCA, etc). The candidates are also expected to mentor and help develop the next generation dermatologists. The senior candidate will be expected to be part of the department management team and interact with senior hospital and school leadership. The ideal candidate should have: • Have experience in lasers, and cosmetic procedures, including for skin of color., • Have a robust interest in academics, teaching, scholarly projects, and clinical/translational or basic research, and particularly in conditions involving patients of color., • Strong academic record of publications and research, • Track record of foundation/NIH grants (particularly senior candidate), • Have a collegial and team player mindset, be able to thrive in a team environment, • Experience in clinical trials This opportunity provides: • Large patient and referral base of diverse ethnic backgrounds, including a large skin of color population, • Ability to develop the US (and beyond) leading clinical and research center for skin of color, • Supportive and experienced clinical staff, • State of the art clinical trial unit, clinical and translational research environment and affiliated laboratories with world-renown faculty, • Competitive salary and dedicated CME time and fund, • Excellent benefits package, including relocation bonus, • Academic Appointment at Icahn School of Medicine at Mount Sinai (appointment requested at level commensurate with academic track record), • Academic opportunities and collaborations with world renowned physician scientists to foster academic and professional development, • Compensation range from 300K to 600K (not including bonuses / incentive compensation or benefits) Qualifications: • Board Certified/Board Eligible, • Must obtain and maintain a medical license in the State of New York, • Track record of academic productivity, research and publications, including in skin of color, • Experience in clinical trials and/or Clinical/translational Research is a plus, • Expertise in Cosmetic procedures and Lasers is a plus Salary Disclosure Information: Mount Sinai Health System provides a salary range to comply with the New York City law on Salary Transparency in Job Advertisements. Actual salaries depend on a variety of factors, including experience, specialties, historical productivity, historical collections, and hospital/community need. As such, an actual salary may fall closer to one or the other end of the range, and in certain circumstances, may wind up being outside of the listed salary range. The salary range listed is for full-time employment and does not include bonuses / incentive compensation or benefits. Equal Opportunity Employer The Mount Sinai Health System is an equal opportunity employer, complying with all applicable federal civil rights laws. We do not discriminate, exclude, or treat individuals differently based on race, color, national origin, age, religion, disability, sex, sexual orientation, gender, veteran status, or any other characteristic protected by law. We are deeply committed to fostering an environment where all faculty, staff, students, trainees, patients, visitors, and the communities we serve feel respected and supported. Our goal is to create a healthcare and learning institution that actively works to remove barriers, address challenges, and promote fairness in all aspects of our organization.

The Cardiothoracic Surgery Service Line at Northwell Health is seeking a full-time Nocturnist to join our team in the Cardiothoracic Surgery ICU at Lenox Hill Hospital. Candidates must be fellowship trained, and Board Certified in Critical Care. Primary board certifications can include Internal Medicine, Anesthesia, Emergency Medicine, or General Surgery. Candidates graduating from their sub-specialty training will also be considered depending upon experience during fellowship training. The ideal candidate should also carry exceptional inter-personal skills with a goal of sharing a vision of unparalleled delivery of care through teamwork, collaboration, innovation, and persistence for excellence. Lenox Hill Hospital is a 450-bed, acute care facility on Manhattan's Upper East Side with a 12-bed CT ICU. Our cardiac surgical team performs surgeries including but not limited to all open cardiac procedures, transcatheter-based therapies and advanced heart failure management including ECMO. Our cardiac surgery program consistently receives the highest quality ratings from the NYS Department of Health and the Society for Thoracic Surgeons. One of the nations largest health care systems, Northwell Health delivers world-class clinical care throughout the New York metropolitan area, pioneering research at The Feinstein Institute for Medical Research and a visionary approach to medical education highlighted by the Hofstra Northwell School of Medicine. We offer a competitive salary and benefits package. In addition, an academic appointment with the Hofstra Northwell School of Medicine is commensurate with credentials and experience. Physicians will be employed as members of Northwell Physician Partners, the seventh largest medical group in the country. You will have immediate access to a team of highly experienced real estate professionals in every community surrounding the Health System. To help orient candidates we provide neighborhood tours and community profiles, including school, transportation, and housing information. Northwell Health is New York States largest health care provider and private employer, with 21 hospitals, 850+ outpatient facilities, and more than 16,600 affiliated physicians. We care for over two million people annually in the New York metro area and beyond, thanks to philanthropic support from our communities. Our 80,000 employees 18,900 nurses and 4,900 employed doctors, including members of Northwell Health Physician Partners are working to change health care for the better. Were making breakthroughs in medicine at the Feinstein Institutes for Medical Research and training the next generation of medical professionals at the visionary Donald and Barbara Zucker School of Medicine at Hofstra/Northwell. Our professionals are relentless about staying ahead of the latest clinical trials and research, partnering with our own Feinstein Institute and other world-renowned institutions. For additional information and to apply, please contact: Lina Sanchez, Office of Physician Recruitment, ___ or visit our webpage to learn more ___ Northwell Health is an Equal Opportunity Employer. EOE M/F/D/V

Northwell Healths Department of Cardiology at Lenox Hill Hospital, a leading provider of comprehensive cardiac care located on Manhattans Upper East Side, is seeking a highly motivated and skilled inpatient cardiologist to provide exceptional care to our diverse patient population. This is an exceptional opportunity to practice at a renowned academic hospital with high-acuity cardiac care, advanced imaging, and a full spectrum of interventional, structural, electrophysiology, and heart failure services. Responsibilities: * Provide comprehensive inpatient cardiology consultations and management. * Perform and interpret diagnostic tests, such as EKGs, echocardiograms, and stress tests. * Develop and implement treatment plans for patients with various cardiovascular conditions. * Collaborate with a multidisciplinary team of healthcare professionals. * Participate in quality improvement initiatives and research activities. * Actively engage in teaching and mentoring medical students and residents. Lenox Hill Hospital is a 652-bed, acute care hospital located on Manhattans Upper East Side with a national reputation for world-class patient care. We offer innovative medical and surgical treatments at one of the largest and most sophisticated hospitals in New York City, as well as seamless, convenient access to care at Manhattan Eye, Ear & Throat Hospital (MEETH), Lenox Health Greenwich Village, our outpatient practices, and our regional and system hospitals. Patients come to us from Manhattan, Brooklyn, the Bronx, Queens, Westchester, New Jersey, Long Island, the tri-state area, and even around the world. Were ranked among the best hospitals in the nation by U.S. News & World Report for cardiology & heart surgery. This is a full-time, academic position with vast clinical, research, and teaching opportunities. The ideal candidate will be Board Certified/Eligible in cardiovascular diseases and echocardiography, with a strong foundation in inpatient cardiology, and have proficiency in TTE and TEE. Nuclear Cardiology and cardiac CT (Level II/III) certifications are preferred. To make the transition as smooth as possible, you will have partners who have a wealth of experience in all the specialty areas of cardiology. There is a true camaraderie within the group. Moreover, you will have access to the expertise of largest health system in the New York Metropolitan area. Northwell Health is dedicated to advancing heart care through providing access to exclusive clinical trials, developing groundbreaking treatments and leading the way in novel research that redefines care. By participating in research and exclusive clinical trials, our physicians are able to provide patients with medical treatments of the future, today. Northwell Health is New York States largest health care provider and private employer, with 28 hospitals and 1,050 outpatient facilities. We care for over thirteen million people annually in the New York metro area and Connecticut, thanks to philanthropic support from our communities. Our 104,000 employees 22,000+ nurses and 13,000+ credentialed physicians, including members of Northwell Health Physician Partners are working to change health care for the better. Were making breakthroughs in medicine at the Feinstein Institutes for Medical Research. We're training the next generation of medical professionals at the visionary Donald and Barbara Zucker School of Medicine at Hofstra/Northwell and the Hofstra Northwell School of Nursing and Physician Assistant Studies. Northwell Health offers a competitive salary and benefits package. In addition, an academic appointment with The Zucker School of Medicine at Hofstra/Northwell is commensurate with credentials and experience. Physicians will be employed as members of Northwell Physician Partners, the fifth largest medical group in the country. or visit our webpage to learn more ___

The Oncology Research Nurse Coordinator is a highly skilled Registered Nurse who plays a pivotal role in the execution and management of oncology clinical trials. Registered Nurse, Oncology Research RN. This role blends clinical expertise with research precision—serving as the bridge between patie

The Oncology Research Nurse Coordinator is a highly skilled Registered Nurse who plays a pivotal role in the execution and management of oncology clinical trials. ONS Oncology Certified Nurse (OCN) or Advanced OCN (AOCN) preferred. Registered Nurse, Oncology Research RN.

The Oncology Research Nurse Coordinator is a highly skilled Registered Nurse who plays a pivotal role in the execution and management of oncology clinical trials. Minimum 1 year of oncology experience required. ONS Oncology Certified Nurse (OCN) or Advanced OCN (AOCN) preferred.

The oncology clinical research nurse works independently under the general supervision of the Clinical Trials Office Management and Leadership and the Principle Investigator for the specific protocol in order to competently support the safe, high quality and compliant conduct of oncology clinical re

Senior Clinical Trial Manager / Associate Director, Clinical Operations Location: New York, NY preferred - hybrid schedule with 3 onsite days per week. Our client, a clinical-stage biotech advancing innovative oncology therapies, is looking to add a senior-level Clinical Operations leader to support a growing global early phase pipeline. This is a highly urgent hire. The position is ideal for someone who is deeply execution-oriented, comfortable in a lean environment, and experienced running complex oncology studies with meaningful CRO and vendor oversight. What you’ll be doing • Managing global Phase 1/2 oncology trials with broad operational ownership, • Overseeing CROs and external vendors across multiple regions, • Supporting studies in emerging geographies including Australia, South Africa, and India, • Partnering closely with internal functions such as Regulatory, Safety, Data Management, and Clinical Supply, • Driving timelines, solving operational issues, and keeping studies on track in a fast-moving environment What our client is looking for • 6+ years of clinical trial management experience, • Strong oncology background, ideally with early phase studies, • Proven ability to run trials independently in a lean biotech or similar setting, • Global trial experience, especially outside the US, • Strong ICH-GCP knowledge and full lifecycle trial execution experience, • Radiopharmaceutical experience is a plus, but not required Why this role stands out • High-visibility position with immediate impact, • Opportunity to work at a scope that feels broader than title, • Strong exposure to leadership in a collaborative, growing team, • Base salary targeted around $160k-$180K, with flexibility up to ~$200K plus equity and benefits

Lab Data Manager Hybrid - Jersey City, NJ or San Francisco, CA Position The Lab Data Manager will be responsible for timely and high-quality management of local lab reference ranges supporting the client's portfolio including the loading of Lab Normal Ranges (LNR) within the EDC system and the management of LNR issue tracking and health status of a particular lab, site or study. Responsibilities • Review and quality control (QC) the reference ranges provided by the site or, if applicable, other functional groups., • Create lab normal range import file and uploads it into EDC local lab module., • Be responsible for LNR issue tracking and maintaining health status at lab, site, and study level for communication to Data Management leadership or other cross functional teams., • Manage local lab range units within the EDC system including change control process., • Collaborate with Data Management colleagues, and study site personnel to continuously improve the collection and loading of LNR data., • Provide LNR training for Data Management and other functions as required., • Be responsible for the creation and maintenance of any Data Management owned controlled documents and provide SME knowledge to any cross functional controlled documents related to LNRs., • Act as the LNR SME for Health Authority inspections and audits., • Serve as a primary point of contact for internal and external study team members regarding local lab reference ranges., • Serve as a backup for medical coding activities. Qualifications • 6+ years of experience with a Bachelor's degree in a health related field (Chemistry, Nursing, etc.); or 4+ years of experience with a post graduate degree, • Proven experience in clinical data management gained from working at recognized clinical data management suppliers/vendors, reputable CRO(s) and/or a Sponsor environment working on multi-phase, multi-therapeutic (Oncology experience will be preferred) and diverse clinical trials from study initiation to completion and associated regulatory submission and inspection preparation., • 3+ years of experience focused on the collection and maintenance of local lab reference ranges within standard clinical data management systems., • Expertise with Lab analytes collected and tested in Oncology clinical trials is preferred., • Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors., • Sound knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management and local lab ranges., • Strong knowledge and experience of EDC systems (Veeva CDMS preferred); demonstrated knowledge of Microsoft Office skills and well versed in industry trends and emerging technologies supporting data collection., • Experience using a Local Lab Module within a standard EDC system is required., • Strong project management, metrics analysis and reporting methodologies experience., • Excellent oral and written communication skills and able to communicate effectively with senior management and cross-functional teams., • Good knowledge of CDASH/CDISC (CDASH CRF Library implementation experience is preferred)., • Knowledge of submission requirements, [e.g. New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application (MAA)].

The Financial Coordinator is responsible for overseeing the financial management of assigned oncology clinical trials. We have an exciting opportunity to join our team as a Financial Coordinator. The Financial Coordinator, under the direction of the Asst.

Job Description Title: Data Entry Specialist Location: Secaucus, NJ Status: Per-diem Reports To: Manager, Clinical Operations Company Frontage Laboratories Inc. is an award winning, publicly listed, full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada, and China, growing significant YoY growth. Our core competencies include pre-clinical, drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. Position Summary: The Data Entry Specialist is responsible for the accurate and timely entry of clinical trial data into electronic data capture (EDC) systems in compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. This role supports the clinical research team by ensuring data integrity, completeness, and readiness for monitoring, audits, and data analysis. Responsibilities: • Accurately enter clinical trial data from source documents into EDC systems in a timely manner., • Assist with data review for completeness, consistency, and accuracy prior to submission., • Assist with resolving data queries generated by sponsors, monitors, or data management teams., • Maintain organized and up-to-date study records, including source documentation and tracking logs., • Collaborate with Clinical Research Coordinators (CRCs), investigators, and other site staff to clarify data discrepancies., • Ensure compliance with study protocols, SOPs, and regulatory requirements (e.g., FDA, ICH-GCP)., • May assist with data cleaning activities and preparation for database lock., • Track data entry progress and provide regular updates to management., • Support audits and monitoring visits by providing requested data and documentation., • High school diploma or equivalent required; Associate’s or Bachelor’s degree in life sciences, healthcare, or related field preferred., • Previous experience in data entry, preferably in clinical research or healthcare setting., • Familiarity with EDC systems (e.g., Medidata Rave, Oracle, or similar) is preferred., • Knowledge of clinical research processes and GCP guidelines is a plus., • Strong attention to detail and high level of accuracy., • Excellent organizational and time management skills., • Proficient in Microsoft Office (Excel, Word, Outlook)., • Ability to manage multiple tasks and meet tight deadlines. Benefits: • 401k Employer Match with immediate vesting, • Vision Insurance, • Medical and Dental Insurance with multiple coverage options, • FSA (Medical, Dependent Care, and Commuter), • Short Term Disability, • Long Term Disability, • Life Insurance

Proven experience in clinical data management gained from working at recognized clinical data management suppliers/vendors, reputable CRO(s) and/or a Sponsor environment working on multi-phase, multi-therapeutic (Oncology experience will be preferred) and diverse clinical trials from study initiatio

Job Description Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 100+ clinical research sites across the US and Europe, accelerating the path to market for novel therapies. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need. At Iterative Health, we are transforming clinical research through the power of AI, technology, and human expertise. Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to improve patient outcomes. Through the Iterative Health Site Network — a premier network of 100+ clinical research sites across the US and Europe — we help expand and expedite access to novel therapeutics for patients in need. Why This Role Matters As Iterative Health continues to scale, we are looking for a strategic and forward-thinking Talent Acquisition Partner to help shape the teams powering our mission. This role is more than recruiting, it is an opportunity to influence growth, elevate the candidate experience, and help build the future of clinical research innovation. You will lead full-cycle recruiting across a broad portfolio of functions including corporate, operations, and clinical research hiring across the organization. This is an ideal opportunity for someone who thrives in fast-paced, mission-driven environments and enjoys balancing strategy, relationship-building, and execution. Where You'll Drive Impact • Act as the first point of contact for candidates and serve as a brand ambassador who champions the Iterative Health mission, culture, and employer brand throughout the hiring journey, • Lead full-cycle recruitment across a variety of roles including corporate, operational, and clinical research positions, • Partner closely with hiring leaders to understand business needs, workforce planning priorities, and evolving talent strategies, • Serve as a trusted advisor to hiring managers by providing market insights, talent intelligence, and consultative recruiting guidance, • Build and execute proactive sourcing strategies to attract diverse, high-quality talent in competitive markets, • Champion an exceptional candidate experience from initial outreach through offer acceptance, • Proactively source, engage, and build strong talent pipelines to support both immediate hiring needs and long-term organizational growth, • Drive alignment and consistency across hiring processes, interview practices, and candidate evaluation approaches, • Develop creative, scalable recruiting strategies and approaches that support organizational growth and operational excellence, • Leverage recruiting data, metrics, and market trends to drive continuous improvement and informed hiring decisions, • Identify opportunities to enhance recruiting systems, processes, and operational efficiencies as the organization grows, • Collaborate cross-functionally with People Operations, HRBPs, hiring managers, and leadership to optimize recruiting processes and workflows, • Support initiatives related to employer branding, talent engagement, process improvement, and recruiting operations, • Contribute to additional talent initiatives and cross-functional projects that support organizational growth, • Collaborative and low-ego team environment, • Fast-moving and highly iterative culture, • Strong focus on ownership and accountability, • Mission-driven and patient-centered mindset, • Open communication and continuous learning, • Comfortable navigating evolving business needs What You Bring to the Team, • 4+ years of full-cycle recruiting experience, • Experience recruiting across multiple functional and national areas, • Strong partnership and stakeholder management skills with the ability to influence at all levels of the organization, • A proactive, resourceful, and solutions-oriented mindset, • Exceptional communication and relationship-building abilities, • Passion for delivering a high-touch candidate experience, • Ability to manage multiple searches simultaneously while maintaining attention to detail and urgency, • Experience working within Greenhouse or similar ATS platforms is strongly preferred We believe great teams do their best work when they feel supported — professionally and personally. • Hybrid work environment with in-office collaboration two days per week in either our NYC or Boston office, • Comprehensive medical, dental, and vision coverage, with up to 80% of premiums covered by Iterative Health, • Mental health and wellness support through Spring Health, • Health HSA or FSA options, and commuter FSA contributions supported by Iterative Health, • Unlimited PTO, 12 company holidays, and a company-wide shutdown between Christmas and New Years, • 401(k) program with a company match of up to 3% (up to $3,000 annually), • Weekly in-office lunch benefit every Tuesday, • 100% company-paid short-term and long-term disability coverage, • Annual wellness and professional development stipend to support your health and growth

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)