Executive Medical Director, Clinical Development
Beeline Medicines · Boston
Job description
About the role
Beeline Medicines is seeking an Executive Medical Director to lead clinical development programs for its precision‑therapy pipeline targeting autoimmune and inflammatory diseases. Reporting to the Chief Medical Officer, you will own the medical strategy, protocol design, and oversight of trials from early‑phase through late‑stage development.
Key responsibilities
- Serve as the physician medical lead for assigned assets, defining clinical strategy and development plans across Phase I‑IV.
- Lead design, development, and review of trial protocols, informed consent forms, investigator brochures, and regulatory submissions (IND, NDA/BLA, global filings).
- Provide ongoing medical oversight, including safety monitoring, SAE review, protocol deviation assessment, and benefit‑risk evaluation.
- Represent the organization in regulatory interactions, investigator engagements, and cross‑functional program teams.
- Drive programs toward regulatory submission and approval in a fast‑paced, growth‑stage biotech environment.
Required profile
- Board‑certified physician‑scientist with extensive experience leading clinical development programs.
- Proven track record in designing and executing early‑ to late‑phase clinical trials.
- Strong expertise in regulatory affairs and interactions with health authorities.
- Excellent leadership, communication, and cross‑functional collaboration skills.
Required skills
- Clinical trial protocol development
- Regulatory submission preparation (IND, NDA/BLA)
- Medical safety monitoring and pharmacovigilance
- Benefit‑risk assessment and serious adverse event review
What we offer
- Hybrid work arrangement (minimum two on‑site days per week).
- Opportunity to shape innovative therapies for unmet medical needs.
- Collaborative environment with world‑class investors and leadership.
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Published 5 hours ago
Expires 1 month from now
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Beeline Medicines
Boston
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