Senior Medical Director, Clinical Development | Boston Area | Therapeutic Area Flexible
I’m working with a clinical-stage biotech in the Boston area that is looking to add a Senior Medical Director, Clinical Development to its team. The company is open to candidates coming from a range of therapeutic areas, but is specifically seeking an experienced physician who can take meaningful clinical leadership across development programs and be closely involved in trial strategy, execution, safety, and regulatory interactions.
This is a highly cross-functional role with visibility across Clinical Development, Clinical Operations, Regulatory, CRO partners, and external KOLs. The ideal candidate will bring strong clinical development experience and the ability to operate both strategically and hands-on in a growing biotech environment.
What you’ll be doing:
- Provide medical leadership across clinical development programs, with responsibility for clinical strategy and trial execution
- Serve as the internal medical lead and work closely with CRO medical monitors and clinical operations teams throughout study conduct
- Lead the medical review of safety data, adverse events, eligibility, protocol deviations, and emerging safety signals
- Partner with CROs and study teams to proactively identify and address clinical or operational issues
- Review and contribute to protocols, informed consent forms, monitoring plans, clinical development plans, and other key trial documents
- Lead or contribute to the preparation and review of safety reports, including DSURs, ASRs, and other regulatory safety deliverables
- Support clinical strategy and preparation for health authority interactions, including pre-IND, IND, and End-of-Phase meetings
- Develop and maintain relationships with KOLs and external clinical experts to inform trial design, execution, and interpretation of data
- Partner with cross-functional stakeholders on clinical data review, statistical analyses, and interpretation of study results
- Contribute to clinical publications, presentations, and dissemination of clinical data
- Provide medical and scientific guidance to Clinical Operations and other members of the development organization
- Serve as a senior medical resource across the program and help drive clinical decisions as the development portfolio evolves
What they’re looking for:
- MD or equivalent medical degree with active US medical licensure
- 4+ years of clinical development experience within biotech or pharmaceutical development
- Experience in early- to mid-stage clinical development strongly preferred
- Prior experience serving as a Medical Monitor or medical lead across clinical trials
- Demonstrated experience with clinical trial safety oversight and medical review
- Experience contributing to or leading interactions with health authorities, ideally including pre-IND, IND, and/or End-of-Phase meetings
- Strong understanding of clinical trial design, execution, safety assessment, and interpretation of clinical data
- Experience working directly with CROs and cross-functional clinical development teams
- Ability to establish strong relationships with KOLs and external clinical experts
- Board certification or eligibility in Internal Medicine or another relevant specialty preferred, but not required
- Strong communication skills and the ability to operate effectively in a fast-paced, evolving biotech environment
- Comfortable taking ownership, making clinical decisions, and working with a high degree of autonomy