Senior Medical Director, Clinical Development

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 executionServe as the internal medical lead and work closely with CRO medical monitors and clinical operations teams throughout study conductLead the medical review of safety data, adverse events, eligibility, protocol deviations, and emerging safety signalsPartner with CROs and study teams to proactively identify and address clinical or operational issuesReview and contribute to protocols, informed consent forms, monitoring plans, clinical development plans, and other key trial documentsLead or contribute to the preparation and review of safety reports, including DSURs, ASRs, and other regulatory safety deliverablesSupport clinical strategy and preparation for health authority interactions, including pre-IND, IND, and End-of-Phase meetingsDevelop and maintain relationships with KOLs and external clinical experts to inform trial design, execution, and interpretation of dataPartner with cross-functional stakeholders on clinical data review, statistical analyses, and interpretation of study resultsContribute to clinical publications, presentations, and dissemination of clinical dataProvide medical and scientific guidance to Clinical Operations and other members of the development organizationServe 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 licensure4+ years of clinical development experience within biotech or pharmaceutical developmentExperience in early- to mid-stage clinical development strongly preferredPrior experience serving as a Medical Monitor or medical lead across clinical trialsDemonstrated experience with clinical trial safety oversight and medical reviewExperience contributing to or leading interactions with health authorities, ideally including pre-IND, IND, and/or End-of-Phase meetingsStrong understanding of clinical trial design, execution, safety assessment, and interpretation of clinical dataExperience working directly with CROs and cross-functional clinical development teamsAbility to establish strong relationships with KOLs and external clinical expertsBoard certification or eligibility in Internal Medicine or another relevant specialty preferred, but not requiredStrong communication skills and the ability to operate effectively in a fast-paced, evolving biotech environmentComfortable taking ownership, making clinical decisions, and working with a high degree of autonomy Message me directly for additional details or a confidential conversation: tanya.kochan@meetlifesciences.com