Sr Director, Clinical Development GI (MD)
Gilead
- Foster City, CA
- Permanent
- Full-time
- Provides input into or leads the development of the Target Product Profile and Clinical Development Plan for assigned molecules /products.
- Provides scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelines.
- Provides input into, or otherwise leads, clinical trial protocol design, clinical study reports and health authority inquiries.
- Provides ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.
- Manages the clinical development component(s) in the preparation/review of regulatory documents, investigator brochures and development plans.
- Coordinates the collection and assimilation of ongoing data for internal analysis and review.
- Coordinates and manages the preparation and/or review of data listings, summary tables, study results and scientific presentations.
- Presents scientific information at scientific conferences as well as clinical study investigator meetings.
- Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.
- MD or equivalent with 6+ years’ clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment.
- Board certification in Gastroenterology is preferred, including familiarity with IBD management or inflammatory disease management..
- Experience in the biopharma industry is preferred.
- Significant experience working on, with and leading cross-functional project/program teams in life sciences, healthcare, consulting or academia.
- Experience taking the lead on study concept and protocol design, regulatory filings, clinical publications and presentations.
- Demonstrated excellence in complex project management and effectively managing multiple clinical project deliverables and priorities through matrix management and leadership.
- Proven analytical abilities as demonstrated through past experience and/or academic research.
- Has core expertise in the assigned or related disease area, as evidenced by ability to independently lead clinical development for deliverables for one or more projects.
- Has thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials.
- Has advanced knowledge of R&D and major disease areas, as evidenced by effectiveness supporting clinical projects.
- Strong communication and organizational skills. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives and steering committees.
- When needed, ability to travel.
- Open to only WEST COAST candidates or candidates who are open to relocation.
- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.