Senior Medical Director, Clinical Development
$293,000–$379,500 year
HybridBoston, Massachusetts, United States
Job Summary
Own the clinical development strategy and integrated plan for assigned Phase I through III assets, serving as the primary physician lead for medical decision-making. Lead the design, authorship, and review of protocols, investigator brochures, informed consent documents, and regulatory submissions while providing comprehensive medical oversight of ongoing trials, including safety monitoring, SAE assessment, and benefit-risk evaluation. Represent the organization in FDA and EMA meetings as the primary medical spokesperson, drive cross-functional clinical program teams, and build relationships with key opinion leaders and principal investigators.
Required Qualifications
- Advanced clinical degree (MD or DO)
- Minimum of 10 years of combined clinical and pharmaceutical/biotech industry experience
- Minimum of 5 years in a clinical development role with increasing levels of responsibility
- Deep scientific expertise in autoimmune disease
- Deep clinical and scientific expertise in immunology and inflammation
- Proven ability to identify, characterize, and mitigate clinical, operational, and regulatory risks across multi-site, multinational clinical programs
- Demonstrated ability to serve as the senior medical authority on cross-functional program teams
- Strong track record of leading clinical programs through critical milestones — including first-in-human studies, proof-of-concept readouts, pivotal trial initiation, and regulatory submissions
- Effective at delivering data-driven recommendations to senior leadership
- Collaborative and influential leader who builds trust and credibility with clinical investigators, KOLs, and regulatory agencies
- Exceptional scientific and medical communication skills
- Skilled in authoring and reviewing high-quality clinical documents including protocols, investigator brochures, clinical study reports, regulatory briefing documents, and scientific manuscripts
Desired Qualifications
- Board certification or clinical training in rheumatology, nephrology, immunology, or a related specialty
- Additional advanced degree (PhD, MPH, or MBA)
- Experience in a clinical development role with increasing levels of responsibility
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