Associate Principal Clinical Scientist
PharmaBiotechClinical ResearchRegulatory AffairsQuality Assurancemedicalgcpclinical data managementemacroraveinform
Job description
Job Description Job Summary The Associate Director of Clinical Science leads the clinical/scientific execution of one or more assigned studies and contributes to broader program-level activities. Serving as a key peer to the Clinical Director and partnering with the Study Manager as the clinical science counterpart on the study team, the Associate Director of Clinical Science provides scientific leadership across study design, execution, medical data review, and interpretation and helps integrate clinical/scientific insights across studies. The Associate Director of Clinical Science , integrates clinical and scientific expertise to inform complex study and program-level decisions, regulatory deliverables, issue management, and cross-functional execution. The individual also provides scientific guidance, coaching, and oversight to less experienced Clinical Scientists. Your responsibility in this role will include: • Lead and coordinate clinical/scientific execution across assigned studies, ensuring quality and consistency of Clinical Science activities • Lead study design and protocol development in collaboration with Clinical Directors and other cross-functional partners and serve as a key point of contact for scientific/strategic study questions • Lead medical monitoring and medical data review across assigned studies, integrating insights and ensuring consistency of approach and interpretation across studies • Integrate clinical data across studies to identify emerging trends, risks, and scientific insights and translate findings into study and program-level recommendations • Lead development and review of Clinical Study Reports and key regulatory documents, integrating cross-functional input and ensuring consistency of clinical/scientific content • Lead development of clinical/scientific content for study and site training across assigned studies • Co-lead governance strategy and materials with Clinical Directors and communicate integrated clinical/scientific findings and recommendations • Lead and contribute to scientific publications and external scientific engagement and develop relationships with investigators and key opinion leaders • Lead identification and management of clinical/scientific quality risks and audit and inspection readiness across assigned studies • Integrate clinical data, digital, and AI-enabled approaches across study activities to improve execution and decision-making, and identify opportunities for broader adoption across study teams • Coach and mentor Clinical Scientists and provide scientific guidance and oversight across assigned study activities • May lead and manage Clinical Scientists • Applicable to Non-Oncology Clinical Science roles: Lead post-database lock exploratory analyses across studies to identify scientific insights and generate hypotheses that may inform endpoint selection, indication expansion, or future studies Core Skills • Ability to integrate regulatory, drug development, and commercial considerations to inform study- and program-level decisions • Ability to apply therapeutic-area expertise, emerging science, and clinical practice to inform study- and program-level strategy • Ability to independently lead clinical/scientific execution across one or more studies • Ability to interpret complex clinical data, integrate insights across studies, and translate findings into recommendations • Ability to connect study design, protocol operationalization, data collection, and relevant scientific literature to inform study planning and decision-making • Ability to lead and coordinate complex priorities, risks, dependencies, and deliverables across studies • Strong scientific judgment and ability to navigate complex clinical and operational issues with substantial independence • Ability to lead scientific discussions and build alignment across internal and external stakeholders • Strong clinical/scientific communication and presentation skills across internal and external audiences • Ability to leverage clinical data, monitoring / RBQM, digital, and AI-enabled tools to identify trends and risks and inform decisions across studies • Ability to coach and mentor Clinical Scientists and contribute to broader Clinical Science capability building Education/Experience • Advanced healthcare or scientific degree (e.g., PhD, PharmD), or equivalent, with 4+ years of pharmaceutical, clinical drug development, and/or medical field experience preferred • Master’s degree, preferably in life sciences, with 6+ years of pharmaceutical, clinical drug development, and/or medical field experience • Bachelor’s degree, preferably in life sciences, with 8+ years of pharmaceutical, clinical drug development, and/or medical field experience Additional location(s) Compensation Information: Required Skills: Analytical Problem Solving, Clinical Data Management, Clinical Development, Clinical Documentation, Clinical Operations, Clinical Reporting, Clinical Research, Clinical Trials Operations, Data Analysis, Drug Development, Ethical Standards, Good Clinical Practice (GCP), Pharmaceutical Sciences Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 11/27/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
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