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Sr. Director – Clinical Development
| Company | Gilead Sciences |
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| Location | San Mateo, CA, USA |
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| Salary | $302005 – $390830 |
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| Type | Full-Time |
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| Degrees | MD |
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| Experience Level | Senior, Expert or higher |
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Requirements
- MD or equivalent with 6+ years clinical, scientific, and/or drug development experience in the biopharma industry, academia, or a related environment
Responsibilities
- Lead or oversee clinical trial protocol design, analysis planning, clinical study report development, and response to health authority inquiries
- Provide scientific and clinical leadership or oversight in the preparation, review, and interpretation of clinical study data, ensuring high quality data
- Oversee or perform clinical study medical monitoring, including but not limited to assessment of eligibility criteria, addressing investigator questions, safety monitoring, and ensuring high data quality through data review as part of a cross-functional team
- Lead the development of the target product profile and clinical development plan for assigned molecules /products considering both strategic and technical aspects
- Contribute to global regulatory filing strategy and lead clinical development contributions in the preparation and review of regulatory documents
- Provide scientific and clinical leadership or oversight in the preparation of investigator brochures
- Provide scientific and clinical leadership to cross-functional teams including real world evidence and health economics and outcomes efforts
- Present data at scientific conferences, clinical study investigator meetings, or to regulatory authorities, as needed
- Adhere to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs
Preferred Qualifications
- Board certification in hepatology or gastroenterology is preferred; other backgrounds including pulmonology, rheumatology, or other internal medicine background with experience in clinical research in chronic liver diseases, inflammation/fibrosis, autoimmunity and/or PBC/MASH also considered
- Experience in the biopharma industry with experience in medical monitoring and addressing medical concerns that arise during clinical studies, experience leading study concept and protocol design, and track-record of leading cross-functional projects or teams
- Experience with regulatory filings, clinical publications, and scientific presentations to a range of audiences
- Demonstrated excellence in a fast-paced environment, effectively managing multiple clinical project deliverables and priorities through matrix management and/or oversight of direct reports
- Strong scientific acumen as demonstrated through past research track record, which may include academic research
- Core expertise in the assigned or related disease areas, or strong desire to develop the necessary expertise to function effectively
- Track record of independently leading clinical development deliverables for one or more projects
- Thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical studies
- Strong oral and written communication skills
- Organized and self-motivated
- Collaborative work style with strong interpersonal skills
- Strong desire to develop new expertise and learn new in new areas to accomplish team goals and advance professional development within the biopharma industry
- Ability to travel when needed
