Medical Director, Clinical Development
Beeline Medicines · Cambridge
Job description
About the role
The Medical Director, Clinical Development will provide medical leadership for innovative immunology therapies, overseeing trial design, execution, safety monitoring and regulatory deliverables.
Key responsibilities
- Lead medical oversight for assigned clinical trials, including protocol development, conduct, monitoring, data review and reporting.
- Contribute to clinical development strategy, integrating scientific rationale, regulatory requirements and business objectives.
- Provide medical input on trial design, endpoint selection, biomarker strategy and risk‑based monitoring.
- Support pharmacovigilance activities and safety governance throughout study conduct.
- Engage with investigative sites, key opinion leaders and external advisors to gather insights and support scientific communications.
- Author and review clinical and regulatory documents and support agency interactions.
Required profile
- Advanced clinical degree (MD or DO) or MD/PhD; board certification in rheumatology, nephrology, immunology or related specialty preferred.
- Minimum 5 years of combined clinical and biotech/pharma experience, with direct experience in lupus and/or systemic sclerosis programs.
- Proven experience leading phase 1‑3 clinical studies and authoring regulatory submissions.
- Demonstrated ability to lead cross‑functional teams in a matrixed, fast‑paced environment.
Required skills
- Deep scientific expertise in autoimmune disease, especially rheumatology, lupus or systemic sclerosis.
- Strong scientific communication and writing skills for regulatory documents and scientific publications.
What we offer
- Competitive salary range $266,000–$340,000 USD.
- Discretionary annual bonus and long‑term equity incentives.
- Comprehensive health and wellness benefits, paid time off and flexible hybrid work schedule.
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Published 1 hour ago
Expires 1 month from now
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Beeline Medicines
Cambridge
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