Medical Director

Role 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.

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 trials
• Provide 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 authorities
• Provide medical review and approval of promotional and medical materials in compliance with corporate standards and government/industry regulations
• Oversee the development and management of clinical protocols and amendments, investigator brochures, and clinical study reports
• Develop and maintain close professional relationships with key thought leaders and healthcare practitioners within the medical and scientific community
• Provide impactful medical expertise to clinical, commercial, market access and regulatory partners
• Oversee the evaluation of safety, pharmacology, and efficacy data from ongoing and completed studies
• Oversee manuscripts, abstracts and presentations for scientific meetings and advisory boards
• Conduct literature reviews and prepare summaries to support clinical development programs
• Serve as a medical resource for design and interpretation of clinical and preclinical programs to support existing and new development candidates
• Contribute to clinical trial documents including protocol, ICF, study plans and SAP
• May serve as a medical monitor for one or more studies

Qualifications

• MD required; Board certification in immunology or infectious diseases strongly preferred
• 7+ years of experience in clinical research or drug development from the pharmaceutical/biotechnology industry, preferably spanning clinical activities in phases I through IV
• Experience with monoclonal antibodies or vaccines strongly preferred
• Medical monitoring experience required
• Hands-on participation in successful regulatory approvals is required
• Strong critical thinking and problem-solving skills to plan, organize, and manage resources for successful completion of projects
• Ability to motivate, influence and collaborate with others across all levels of the organization
• Ability to engage internal and external experts in constructive scientific dialogue around study design, conduct and data interpretation
• Broad working knowledge of FDA requirements, industry compliance, clinical trial design and strategies
• Experience 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 development
• Able to conceive and execute innovative approaches to clinical development
• Excellent written, communication and interpersonal skills and proven success working in a multi-functional team-based environment
• Strong project planning, negotiation, and presentation skills as well as an ability to contribute creative yet practical solutions to problems
• Able to prioritize and parallel process multiple work streams, comfortable “shifting gears” and remaining flexible, as well as making definitive decisions
• In-depth understanding of the scientific method and ability to apply this information to business needs based on medical and scientific rationale
• Ability to travel domestically and internationally
• Ability to travel to New Haven, CT

Education

• MD required; Board certification in immunology or infectious diseases strongly preferred