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Clinical Development Expert
1 month ago
Explore a career opportunity with Gilead Sciences, Inc., a leading biopharmaceutical company.
Salary Range: $237,660.00 - $307,560.00
About the RoleWe are seeking an experienced Clinical Development Expert to join our team in Hepatitis treatment. As a key member of our clinical development team, you will provide clinical leadership and input on clinical studies, supporting our hepatitis programs.
You will lead or assist on multiple components of clinical trial programs in Hepatitis clinical development, designing, conducting, and evaluating Phase 1-4 clinical trials. You will also provide expertise in clinical hepatitis, primarily working on developing drugs for HBV cure and HDV.
In collaboration with the Clinical Leads and Global Development Team Leads, you will be responsible for various aspects of ongoing clinical trial program-related activities within the hepatitis therapeutic area.
Responsibilities:
- 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.
- 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.
To be successful in this role, you will require:
Minimum Education & Experience:
- Preference for MD/DO and 4+ years of clinical or biotech/pharma industry experience with a proven success record in clinical research studies, trial design, execution, and oversight.
- PharmD or PhD in clinical research or clinical pharmacology with 8+ years' scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia, or a related environment.
- Preference for applicants with experience in hepatitis D and/or B.
- Relevant experience in Hepatology is preferred.
- Experience in the biopharma industry is preferred.
- Experience working on cross-functional project teams in a global development team.
- Experience taking the lead on study concept and protocol design, regulatory filings, clinical publications, and presentations is preferred.
Gilead Sciences, Inc. offers a comprehensive benefits package, including:
- A salary range of $237,660.00 - $307,560.00.
- A discretionary annual bonus.
- Discretionary stock-based long-term incentives (eligibility may vary based on role).
- Paid time off.
- A benefits package, including company-sponsored medical, dental, vision, and life insurance plans.*
