Senior Medical Director, Clinical Development

The role

The Senior Medical Director provides strategic medical leadership for clinical programs within the Inflammation & Immunology pipeline. This physician-scientist owns clinical strategy and development plans across multiple phases while mentoring junior physicians.

What you will do

• Serve as the physician medical lead for assigned clinical development programs.
• Own clinical development strategy, integrated development plan, and medical decision-making for pipeline assets.
• Lead the design, authorship, and review of clinical trial protocols, investigator brochures, and informed consent documents.
• Lead clinical sections of regulatory submissions including IND, NDA/BLA, and global filings.
• Provide medical oversight of ongoing clinical trials including safety monitoring and SAE assessment.
• Lead and represent the organization in regulatory agency interactions with FDA and EMA.
• Support pharmacovigilance activities during trial conduct.
• Drive cross-functional clinical program teams.
• Build and maintain relationships with key opinion leaders, principal investigators, and academic medical centers.
• Perform other duties and responsibilities as assigned.

Required qualifications

• Advanced clinical degree (MD or DO).
• Minimum of 10 years of combined clinical and pharmaceutical/biotech industry experience.
• Demonstrated experience as a physician lead on Phase I–III clinical programs.
• Experience in protocol development, medical monitoring, and regulatory submission.
• Deep clinical and scientific expertise in immunology and inflammation.
• Ability to identify, characterize, and mitigate clinical, operational, and regulatory risks.
• Ability to serve as the senior medical authority on cross-functional program teams.
• Track record of leading clinical programs through critical milestones.
• Exceptional scientific and medical communication skills.
• Skilled in authoring and reviewing clinical documents including protocols, investigator brochures, and clinical study reports.

Nice to have

• Board certification or clinical training in rheumatology, nephrology, immunology, or a related specialty.
• Additional advanced degree (PhD, MPH, or MBA).
• Minimum of 5 years in a clinical development role with increasing levels of responsibility.
• Deep scientific expertise in autoimmune disease — rheumatology preferred.

Benefits

• Competitive health and wellness coverage.
• Paid time off, public holidays, and additional leave entitlements.
• Flexible work arrangements / hybrid schedule.

About the company

Beeline Medicines is a clinical-stage biotechnology company focused on developing precision therapies for autoimmune and inflammatory diseases. The company is led by an established executive team and backed by life science investors.