Sr Director, Clinical Research
Foster City, CA, USA | Gilead Sciences
Industry:Pharmaceutical / Biotech
Job Description:52 people have viewed this job
The Sr Director, Clinical Research, position will design, conduct, and evaluate Phase 1, 2, and 3 clinical trials and provide scientific expertise on non HIV viral infectious diseases. This role may also be involved in HIV treatment, prevention, and/or cure research.
Interfaces with staff to share scientific and clinical information and consistent practices.
Leads/supports protocol review discussions concerning scientific and procedural aspects of study design.
Serves as resource for junior staff.
Oversees the scientific aspects of clinical studies throughout duration of study.
Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.
Prepares study protocols, amendments, specific sections of study manuals and Investigator meeting notebooks, and other documents as needed.
Supervises or assists other CRS staff with preparation of above. Contributes to the design and development of CRFs, Data Management Manuals and Data Analysis Plans.
Helps ensure consistency across protocols.
Presents scientific information if needed.
Addresses questions regarding scientific and related procedural issues from Investigators.
Coordinates and implements ongoing data for internal analysis and review.
Coordinates/supports the preparation/review of regulatory documents, IND annual reports, IND safety reports, Investigator Brochures and NDAs.
Determines the functions most critical to company success and supports priorities within functional area.
Anticipates fairly complex obstacles and client difficulties and implements solutions that meet goals.
Creates effective teams with a clear sense of direction.
May lead two or more specific components of departmental strategic initiatives.
Knowledge, Experience & Skills:
Typically requires a higher degree MD, PharmD or PhD with 5+ years in clinical research or clinical pharmacology in a pharmaceutical company, contract research organization or academic institution
Excellent verbal and written communication skills and interpersonal skills are required to maintain working relationship with team members to ensure scientific integrity of clinical studies.
Examines functional issues from a broader organization perspective.
Knowledge of clinical trial design to develop specific study concept sheets and protocols is required.
Familiarity with virology and HIV medicine preferred
Clinical or translational research experience preferred
Pharmaceutical/Biotech industry experience in clinical development preferred
Successful leadership and management experience
Excellent organizational and communication skills are critical
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