Medical Director

Role Summary

Medical Director. Location: Northeast Preferred. Reporting to the Senior Vice President/Head of Clinical Development, the Medical Director is a strategic leader and business partner responsible for overseeing clinical trials and the development strategy. The incumbent will be responsible for providing medical and scientific expertise and oversight for clinical development programs and clinical trials, and serves as the point of accountability for design, execution, monitoring, delivery, and reporting of one or more clinical studies. The ideal candidate is someone who thrives in a fast-paced environment, who is a strategic problem solver, and who is proactive, flexible, detail-oriented, and hands-on.

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‚Äôs 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
• 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; MD with 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 ‚Äúshifting gears‚Äù 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 at least 1x a month

Skills

• Medical leadership and strategic input for clinical development
• Medical monitoring and data interpretation
• Regulatory affairs collaboration and scientific communication
• Stakeholder relationship management with thought leaders and healthcare practitioners
• Regulatory dossier preparation and response drafting
• Scientific literature review and synthesis

Education

• MD degree; board certification in immunology or infectious diseases strongly preferred

Additional Requirements

• Ability to travel domestically and internationally
• Availability to travel to New Haven at least 1x a month