Senior Medical Director, Clinical Development — Hybrid

BioSpace; Cambridge (MA); Hybrid; USD 293,000 - 380,000; Full time

Job summary

Beeline Medicines in Cambridge, MA, seeks a Senior Medical Director, Clinical Development to lead strategic medical direction for inflammation and immunology programs. You will shape development plans across Ph I–III, mentor physicians, and drive cross‑functional collaboration in a fast‑paced biopharma setting.

You will interact with regulators, investigators, and KOLs, ensuring rigorous safety monitoring, data integrity, and timely regulatory submissions, with a commitment to science and

Qualifications

• Advanced clinical degree (MD or DO) required; Board certification or clinical training in rheumatology, nephrology, immunology, or related specialty strongly preferred.
• Minimum of 10 years of combined clinical and pharmaceutical/biotech industry experience, with a minimum of 5 years in a clinical development role with increasing levels of responsibility preferred
• Deep scientific expertise in autoimmune disease — rheumatology preferred; experience as physician lead on Phase I–III programs including protocol development, medical monitoring, and regulatory submissions

Responsibilities

• 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 medical centers to strengthen the organization’s clinical network, gather external scientific insights, and support the medical positioning of pipeline assets

Skills

Strategic medical leadership

Clinical development leadership

Medical monitoring & safety

Regulatory submissions

Clinical trial design

KOL relationship building

Cross-functional collaboration

Data-driven decision making

Regulatory communications

Mentoring junior physicians

Education

MD or DO

Board certification in rheumatology/nephrology/immunology preferred

Advanced degree (PhD/MPH/MBA) a plus

Job description

Beeline Medicines in Cambridge, MA, seeks a Senior Medical Director, Clinical Development to lead strategic medical direction for inflammation and immunology programs. You will shape development plans across Ph I–III, mentor physicians, and drive cross‑functional collaboration in a fast‑paced biopharma setting.

You will interact with regulators, investigators, and KOLs, ensuring rigorous safety monitoring, data integrity, and timely regulatory submissions, with a commitment to science and