Senior Medical Director, Clinical Development

About the role

Beeline Medicines is seeking a senior physician‑scientist to lead clinical development programs within its Inflammation & Immunology pipeline. The Senior Medical Director will own the medical strategy for assigned assets from Phase I through Phase III, ensuring scientific rigor and patient safety.

Key responsibilities

• Serve as the physician medical lead for one or more clinical development programs, defining strategy, integrated development plans, and medical decision‑making.
• Design, author, and review clinical trial protocols, investigator brochures, informed consent documents, and the clinical sections of regulatory submissions (IND, NDA/BLA, global filings).
• Provide comprehensive medical oversight of ongoing trials, including safety monitoring, SAE assessment, protocol deviation review, and benefit‑risk evaluation.
• Collaborate with cross‑functional teams—clinical operations, regulatory affairs, biostatistics, and commercial—to align development activities with overall portfolio goals.
• Mentor junior physicians, contribute to departmental capability building, and participate in portfolio‑level strategic discussions.

Required profile

• MD or MD/PhD with extensive experience in inflammation, immunology, or related therapeutic areas.
• Proven track record of leading clinical trials through multiple phases in a biopharmaceutical environment.
• Strong understanding of regulatory requirements and experience preparing IND, NDA/BLA, and global filing documents.
• Ability to work independently, make data‑driven medical decisions, and communicate effectively with internal and external stakeholders.
• Demonstrated leadership and mentorship skills, with a commitment to fostering junior talent.

Required skills

• Clinical trial design and execution.
• Regulatory submission preparation (IND, NDA/BLA, global filings).
• Medical safety monitoring and SAE assessment.
• Benefit‑risk evaluation and medical decision‑making.