Medical Director
Invivyd
June 30, 2026
Remote friendly (Boston, MA)
United States
$184,000 - $245,000 USD yearly
Medical Affairs
Responsibilities:
- In collaboration with Biometrics, Clinical Operations, Regulatory Affairs and Medical Affairs, lead conception, study design, protocols, medical monitoring, and medical interpretation of clinical trials.
- Provide clinical leadership and medical strategic input for assigned project/program deliverables (protocol sections, data review, standards, regulatory document/registration dossier components, and publications such as investigator brochures, briefing books, safety updates, submission dossiers, and health authority responses).
- Lead timely drafting of clinical responses to regulatory questions.
- Review and approve promotional and medical materials in compliance with corporate standards and government/industry regulations.
- Oversee development/management of clinical protocols and amendments, investigator brochures, and clinical study reports.
- Develop and maintain relationships with key thought leaders and healthcare practitioners.
- Provide medical expertise to clinical, commercial, market access and regulatory partners.
- Oversee evaluation of safety, pharmacology, and efficacy data.
- Oversee manuscripts, abstracts and presentations for scientific meetings and advisory boards.
- Conduct literature reviews and prepare summaries.
- Serve as a medical resource for design/interpretation of clinical and preclinical programs.
- Contribute to clinical trial documents (protocol, ICF, study plans and SAP).
- May serve as a medical monitor for one or more studies.
Requirements:
- MD required; board certification in immunology or infectious diseases strongly preferred.
- 7+ years in clinical research/drug development (phases I–IV preferred).
- Medical monitoring experience required.
- Hands-on participation in successful regulatory approvals required.
- Strong critical thinking; ability to motivate/influence/collaborate.
- Broad working knowledge of FDA requirements, clinical trial design/strategies; experience with FDA/global agencies.
- Strong knowledge of GCP, GPV, ICH guidelines and regulatory requirements.
- Excellent written/communication/interpersonal skills; proven success in multi-functional teams.
- Ability to travel domestically/internationally; travel to New Haven, CT.
Preferred:
- Experience with monoclonal antibodies or vaccines.
Pay range (base salary): $184,000 - $245,000.
Application: https://www.invivyd.com/careers/.
- In collaboration with Biometrics, Clinical Operations, Regulatory Affairs and Medical Affairs, lead conception, study design, protocols, medical monitoring, and medical interpretation of clinical trials.
- Provide clinical leadership and medical strategic input for assigned project/program deliverables (protocol sections, data review, standards, regulatory document/registration dossier components, and publications such as investigator brochures, briefing books, safety updates, submission dossiers, and health authority responses).
- Lead timely drafting of clinical responses to regulatory questions.
- Review and approve promotional and medical materials in compliance with corporate standards and government/industry regulations.
- Oversee development/management of clinical protocols and amendments, investigator brochures, and clinical study reports.
- Develop and maintain relationships with key thought leaders and healthcare practitioners.
- Provide medical expertise to clinical, commercial, market access and regulatory partners.
- Oversee evaluation of safety, pharmacology, and efficacy data.
- Oversee manuscripts, abstracts and presentations for scientific meetings and advisory boards.
- Conduct literature reviews and prepare summaries.
- Serve as a medical resource for design/interpretation of clinical and preclinical programs.
- Contribute to clinical trial documents (protocol, ICF, study plans and SAP).
- May serve as a medical monitor for one or more studies.
Requirements:
- MD required; board certification in immunology or infectious diseases strongly preferred.
- 7+ years in clinical research/drug development (phases I–IV preferred).
- Medical monitoring experience required.
- Hands-on participation in successful regulatory approvals required.
- Strong critical thinking; ability to motivate/influence/collaborate.
- Broad working knowledge of FDA requirements, clinical trial design/strategies; experience with FDA/global agencies.
- Strong knowledge of GCP, GPV, ICH guidelines and regulatory requirements.
- Excellent written/communication/interpersonal skills; proven success in multi-functional teams.
- Ability to travel domestically/internationally; travel to New Haven, CT.
Preferred:
- Experience with monoclonal antibodies or vaccines.
Pay range (base salary): $184,000 - $245,000.
Application: https://www.invivyd.com/careers/.