Medical Director

Location: Northeast Preferred
Position Summary:Reporting to the Senior Vice President/Head of Clinical Development, the Medical Director is a pivotal strategic leader at the center of our clinical programs. This role goes beyond oversight; you will help shape development strategy, influence key decisions, and drive the execution of clinical trials that have the potential to change patients’ lives. As the medical and scientific authority for one or more studies, you will be fully accountable for study design, execution, monitoring, delivery, and reporting, partnering closely with cross-functional teams to ensure scientific rigor and operational excellence.The ideal candidate thrives in a fast-paced, entrepreneurial environment and brings both strategic vision and hands-on execution. You are a proactive problem solver who can navigate ambiguity, anticipate challenges, and turn complexity into clear, actionable plans. Detail-oriented yet big-picture focused, you are energized by ownership, collaboration, and the opportunity to build and advance impactful clinical programs from the ground up.
Responsibilities:In collaboration with other departments (Biometrics, Clinical Operations, Regulatory Affairs and Medical Affairs) lead the conception, study design, study protocols, medical monitoring and medical interpretation of Invivyd’s clinical trialsProvide clinical leadership and medical strategic input for deliverables in the assigned project/program. Deliverables will include sections of individual protocols consistent with the clinical development plan (CDP), data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications (e.g., investigator brochures, briefing books, safety updates, submission dossiers, and responses to health authorities)Lead the timely drafting of clinical responses to questions from regulatory authoritiesProvide medical review and approval of promotional and medical materials in compliance with corporate standards and government/industry regulationsOversee the development and management of clinical protocols and amendments, investigator brochures, and clinical study reportsDevelop and maintain close professional relationships with key thought leaders and healthcare practitioners within the medical and scientific communityProvide impactful medical expertise to clinical, commercial, market access and regulatory partnersOversee the evaluation of safety, pharmacology, and efficacy data from ongoing and completed studiesOversee manuscripts, abstracts and presentations for scientific meetings and advisory boardsConduct literature reviews and prepare summaries to support clinical development programsServe as a medical resource for design and interpretation of clinical and preclinical programs to support existing and new development candidatesContribute to clinical trial documents including protocol, ICF, study plans and SAPMay serve as a medical monitor for one or more studies
Requirements:MD required; Board certification in immunology or infectious diseases strongly preferred7+ years of experience in clinical research or drug development from the pharmaceutical/biotechnology industry, preferably spanning clinical activities in phases I through IVExperience with monoclonal antibodies or vaccines strongly preferredMedical monitoring experience requiredHands-on participation in successful regulatory approvals is requiredStrong critical thinking and problem-solving skills to plan, organize, and manage resources for successful completion of projectsAbility to motivate, influence and collaborate with others across all levels of the organizationAbility to engage internal and external experts in constructive scientific dialogue around study design, conduct and data interpretationBroad working knowledge of FDA requirements, industry compliance, clinical trial design and strategiesExperience in interacting with the FDA and/or global regulatory agencies.Strong general knowledge of GCP, GPV, ICH guidelines and regulatory requirements that apply to clinical drug developmentAble to conceive and execute innovative approaches to clinical developmentExcellent written, communication and interpersonal skills and proven success working in a multi-functional team-based environmentStrong project planning, negotiation, and presentation skills as well as an ability to contribute creative yet practical solutions to problemsAble to prioritize and parallel process multiple work streams, comfortable “shifting gears” and remaining flexible, as well as making definitive decisionsIn-depth understanding of the scientific method and ability to apply this information to business needs based on medical and scientific rationaleAbility to travel domestically and internationallyAbility to travel to New Haven, CT
Pay Range$184,000 - $245,000The pay range represents the expected full-time base salary for this role at the time of posting. Actual base pay will be determined based on a variety of factors, including relevant experience, skills, and education. In addition to base pay, this role is eligible for both an annual short-term incentive (e.g., bonus or sales incentive) and an annual long-term incentive (e.g., equity), reflecting our commitment to rewarding strong performance and long-term impact. Learn more about our total rewards by visiting https://www.invivyd.com/careers/.
At Invivyd we strive to create a welcoming and inclusive environment. Here all applicants will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics.
Invivyd is proud to be an equal opportunity employer.
We do not accept unsolicited resumes from agencies.