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Associate Director, Global Clinical Science, Neuroscience

Bristol-Myers Squibb

Position Summary The Associate Director, Global Clinical Science reports through the Clinical Development function and is responsible for the implementation, planning, and execution of assigned clinical trial activities. Responsibilities Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members Plan and lead the implementation of all study startup, conduct, and close‑out activities as applicable Evaluate innovative trial designs in collaboration with Medical Monitor/Clinical Development Lead Develop protocol and ICFs with minimal guidance, including writing, reviewing, resolving cross‑functional comments and ensuring high clinical quality in partnership with Medical Writing Conduct site‑facing activities such as training and serving as primary contact for clinical questions Generate and validate data, including CRF design and clinical data review/query resolution, ensuring consistent, quality data review by the supporting team Identify clinical data trends, provide trends, and escalate questions to Medical Monitor Develop clinical narrative plans and review clinical narratives Provide information required by Protocol Manager for trial budget, CRO scope of work, and related materials Review development of site and CRA training materials and present at SIV and investigator meetings; support study committee activities (e.g., DMC) Draft, review, and validate clinical study reports (CSRs) and clinical portions of regulatory documents (e.g., Investigator Brochure, DSUR, regulatory responses) Collaborate and serve as primary liaison between external partners for scientific advice Qualifications Degree Requirements: Degree in Life Sciences (MD, PhD, Pharm D, MS, RN, or other scientific field preferred) Experience Requirements: 5+ years of experience in clinical science, clinical research, or equivalent Proficient knowledge of GCP/ICH, drug development process, study design, statistics, and clinical operations Proficient knowledge and skills for program‑specific data review, trend identification, and data interpretation Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees Key Competency Requirements Excellent verbal, written, communication and interpersonal skills Effective communication and collaboration across functions and job levels Ability to assimilate technical information quickly Routinely takes initiative and is detail‑oriented Strong sense of teamwork; ability to lead team activities Proficient in medical terminology and medical writing skills Proficient knowledge of disease areas, KOLs, indications, compounds under study (including MOA, PK/PD, biomarker & safety profile) Proficient critical thinking, problem‑solving, and decision‑making skills Understanding of functional and cross‑functional relationships Commitment to quality Adaptable and flexible, able to adjust to multiple demands and shifting priorities while meeting day‑to‑day challenges with confidence and professionalism Proficient planning/project management skills; ability to develop realistic short‑ to mid‑range plans to meet goals Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J‑Review, or similar data reporting tools Travel Required: Domestic and international travel may be required. Equal Employment Opportunity statement available at careers.bms.com/eeo-accessibility. #J-18808-Ljbffr

Vacancy posted 1 day ago
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