Senior Program Medical Director (Clinical Development)
🧬 Position Summary
We are seeking a strategic and experienced Senior Program Medical Director to lead global clinical development programs across multiple therapeutic indications from Phase I through Phase IV, including Biologics License Application (BLA) submissions. This role is central to shaping the medical and scientific direction of our pipeline assets, ensuring clinical excellence, regulatory success, and cross-functional alignment.
🌍 Key Responsibilities
* Clinical Strategy & Execution
* Lead the design, execution, and oversight of global clinical trials across multiple indications and phases (I–IV).
* Develop and refine clinical development plans in collaboration with cross-functional teams.
* Regulatory & Submission Leadership
* Drive clinical components of BLA submissions, including authoring and reviewing key documents (e.g., clinical summaries, safety narratives, integrated summaries).
* Serve as the medical lead during regulatory interactions (FDA, EMA, PMDA, etc.).
* Cross-Functional Collaboration
* Partner with Regulatory Affairs, Biostatistics, Clinical Operations, Pharmacovigilance, and Commercial teams to ensure seamless program execution.
* Provide medical expertise to support lifecycle management, label expansions, and post-marketing commitments.
* Scientific Leadership
* Represent the company at scientific and medical conferences, advisory boards, and investigator meetings.
* Maintain deep knowledge of therapeutic landscapes, competitive intelligence, and emerging trends.
* Team Development
* Mentor and guide junior medical directors and clinical scientists.
* Foster a culture of innovation, accountability, and scientific rigor.
🎓 Qualifications
* MD, DO, or equivalent medical degree required; board certification preferred.
* Extensive industry experience in clinical development, with proven leadership across multiple indications.
* Demonstrated success in BLA submissions and late-phase clinical trials.
* Strong understanding of global regulatory requirements and clinical trial methodologies.
* Exceptional communication, leadership, and strategic thinking skills.
💼 Preferred Experience
* Experience in immunology, neuromuscular, neurology, or rare diseases, or with blockbuster global products
* Prior involvement in global development programs and multinational trial execution.
* Familiarity with digital health tools and decentralized trial models.
🚀 Why Join Us?
* Be part of a mission-driven organization transforming patient care through innovation.
* Lead high-impact programs with global reach and scientific depth.
* Collaborate with world-class experts in a dynamic, inclusive environment.
Reach out now!
Tshering Sherpa
Tsherpa@planet-pharma.co.uk