Senior Director, Drug Development

About the role

The Senior Director, Drug Development leads regulatory strategy and product lifecycle management for oncology-focused biopharma customers. This home‑based position provides strategic consultancy across the entire drug development continuum, from pre‑clinical to market approval.

Key responsibilities

• Lead the development of regulatory submissions (INDs, NDAs, BLAs, MAAs) and obtain special designations such as orphan, fast‑track, or breakthrough.
• Engage with regulatory authorities (FDA, EMA) on behalf of customers, preparing briefing documents and representing the client in meetings.
• Build and manage a global regulatory team, including line‑management duties.
• Assess regulatory risk, develop mitigation plans, and contribute to indication prioritisation, due diligence, and gap analyses.
• Shape product development strategies (TPPs, CDPs, clinical study designs) that align clinical, regulatory, and commercial objectives.
• Deliver high‑quality, data‑driven deliverables that meet medical, ethical, and scientific standards.
• Represent senior customer management in cross‑functional virtual teams and support business development activities.

Required profile

• Master’s degree or higher, or equivalent experience.
• 15‑20+ years of multi‑regional clinical research experience, including senior strategic roles.
• Proven leadership and management capabilities across multiple functional areas.
• Strong strategic thinking, analytical, and communication skills.
• Client‑focused, consultative approach with a track record of meeting or exceeding goals.

Required skills

• Advanced proficiency in Microsoft Excel.
• Advanced proficiency in Microsoft PowerPoint.