Senior Director, Drug Development
New
Based in the United StatesFull-TimeDirector
SalaryCompetitive base salary with significant performance-based compensation potential
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Job Details
- Experience
- 15–20+ years of experience in clinical research and drug development
- Required Skills
- Microsoft ExcelPowerPoint
Requirements
- Master’s degree or higher in life sciences, medicine, pharmacy, or a related field, or equivalent professional experience.
- 15–20+ years of experience in clinical research and drug development with global or multi-regional exposure.
- Proven track record in senior strategic roles within pharmaceutical or biotech drug development environments.
- Strong expertise across clinical development strategy, regulatory affairs, and lifecycle product development.
- Deep understanding of regulatory processes and global health authority interactions (FDA, EMA, and similar agencies).
- Experience developing clinical development plans, protocols, and regulatory submission documents.
- Strong analytical, strategic thinking, and problem-solving capabilities with a data-driven mindset.
- Excellent communication and presentation skills, with the ability to influence senior stakeholders and clients.
- Demonstrated leadership ability managing cross-functional teams and complex development programs.
- High level of proficiency in Microsoft Excel and PowerPoint.
- Strong commitment to scientific rigor, quality, and ethical standards in drug development.
Responsibilities
- Lead the development of integrated drug development strategies spanning preclinical, clinical, regulatory, and commercial dimensions for pharmaceutical and biotech programs.
- Provide expert guidance on clinical development plans, target product profiles, study designs, and regulatory submission strategies (e.g., INDs, NDAs, BLAs, MAAs).
- Conduct regulatory and development risk assessments, including probability of success analyses, gap assessments, and mitigation strategy design.
- Support and participate in interactions with global regulatory authorities (FDA, EMA, and others), including preparation of briefing materials and attendance at meetings.
- Advise on portfolio management decisions, licensing opportunities, and strategic investment evaluations across development programs.
- Contribute to due diligence activities and strategic business development initiatives, including client presentations and partnership discussions.
- Provide leadership within cross-functional drug development teams, ensuring alignment across scientific, clinical, and commercial stakeholders.
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