This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Director, Drug Development based in the United States.
This senior leadership role sits at the core of global pharmaceutical and biotech innovation, driving end-to-end drug development strategy across multiple therapeutic areas.
You will shape integrated clinical, regulatory, and commercial development plans that guide assets from early discovery through approval and market launch.
The role combines scientific depth with strategic advisory influence, supporting high-impact decisions such as go/no-go evaluations, licensing opportunities, and portfolio prioritization.
You will engage directly with regulatory agencies and key industry stakeholders, contributing to submissions and high-level scientific discussions.
This position also plays a visible external role, representing thought leadership through conferences, publications, and strategic client engagements.
Working in a highly collaborative, global environment, you will partner with cross-functional teams to accelerate innovation and improve development success rates.
The role offers the opportunity to directly influence the advancement of therapies that can meaningfully improve patient outcomes worldwide.
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Director, Drug Development based in the United States.
This senior leadership role sits at the core of global pharmaceutical and biotech innovation, driving end-to-end drug development strategy across multiple therapeutic areas.
You will shape integrated clinical, regulatory, and commercial development plans that guide assets from early discovery through approval and market launch.
The role combines scientific depth with strategic advisory influence, supporting high-impact decisions such as go/no-go evaluations, licensing opportunities, and portfolio prioritization.
You will engage directly with regulatory agencies and key industry stakeholders, contributing to submissions and high-level scientific discussions.
This position also plays a visible external role, representing thought leadership through conferences, publications, and strategic client engagements.
Working in a highly collaborative, global environment, you will partner with cross-functional teams to accelerate innovation and improve development success rates.
The role offers the opportunity to directly influence the advancement of therapies that can meaningfully improve patient outcomes worldwide.
Accountabilities:
- 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.
- 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.
- Competitive base salary with significant performance-based compensation potential
- Annual salary range reflective of experience, expertise, and location
- Bonus and incentive programs tied to individual and organizational performance
- Comprehensive health coverage including medical, dental, vision, and wellness benefits
- Retirement savings plan with employer contributions
- Flexible remote/hybrid work arrangements depending on role requirements
- Paid time off, holidays, and additional leave options
- Access to professional development, learning programs, and global scientific engagement opportunities
- Opportunities to participate in conferences, publications, and industry thought leadership initiatives
- Inclusive, global work environment focused on innovation and patient impact.