Senior Medical Director, Clinical Development

Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category‑leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best‑in‑class and first‑in‑disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life‑changing impact.

Led by an established executive team and backed by world‑class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune‑mediated diseases can live life fully.

The Senior Medical Director, Clinical Development is a senior physician‑scientist who provides strategic medical leadership for one or more clinical programs within the organization’s Inflammation & Immunology pipeline. Building on deep therapeutic area expertise and a proven track record in clinical trial execution, this role bridges hands‑on clinical program leadership with broader cross‑functional and organizational accountability. The Senior Medical Director serves as the primary physician lead for assigned assets, owning the clinical strategy and development plan across multiple phases, while also playing an increasingly prominent role in shaping departmental capabilities, mentoring junior physicians, and contributing to portfolio‑level decision‑making.

This role requires the ability to work with independence and authority in a fast‑paced, growth‑stage biopharmaceutical environment.

Hybrid – This position follows a hybrid work schedule, requiring a minimum of two (2) days on‑site per week — currently designated as Tuesday and Wednesday. Additional on‑site days may be required based on business needs, team priorities, or leadership direction.

• Serve as the physician medical lead for assigned clinical development programs — owning the clinical development strategy, integrated development plan, and medical decision‑making for pipeline assets across Phase I through Phase III development, with increasing accountability for program‑level outcomes and portfolio contributions.
• Lead the design, authorship, and review of clinical trial protocols, investigator brochures, informed consent documents, and clinical sections of regulatory submissions (IND, NDA/BLA, global filings) — ensuring scientific rigor, patient safety, and regulatory compliance across all deliverables.
• Provide comprehensive medical oversight of ongoing clinical trials — including safety monitoring, medical monitoring, SAE assessment, protocol deviation review, and benefit‑risk evaluation — in close partnership with Clinical Operations, Pharmacovigilance, and Biostatistics.
• Lead and actively represent the organization in regulatory agency interactions — including FDA and EMA meetings, briefing document development, and responses to health authority questions — serving as a primary medical spokesperson for assigned programs and contributing to regulatory strategy.
• Support pharmacovigilance activities during trial conduct — Drive cross‑functional clinical program teams as the senior medical lead — providing strategic scientific direction to Clinical Operations, Regulatory Affairs, Translational Medicine, Biostatistics, and Medical Affairs — and ensure integrated, high‑quality program execution with clear accountability and pace.
• Build and maintain relationships with key opinion leaders (KOLs), principal investigators, and academic…