Medical Director
Invivyd
4 hours ago
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 clinical trial conception, study design, protocols, medical monitoring, and medical interpretation.
- Provide clinical leadership and medical strategic input for program deliverables, including protocol sections (per CDP), data review, program-specific standards, clinical components of regulatory documents/registration dossiers, and publications (investigator brochures, briefing books, safety updates, submission dossiers, and responses to health authorities).
- Lead timely drafting of regulatory authority clinical responses.
- Provide medical review and approval of 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 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.
- Serve as a medical resource for design and interpretation of clinical and preclinical programs.
- Contribute to trial documents including 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 or drug development (pharma/biotech), preferably across phases I–IV.
- Experience with monoclonal antibodies or vaccines strongly preferred.
- Medical monitoring experience required.
- Hands-on participation in successful regulatory approvals required.
Required skills/knowledge:
- Critical thinking and problem-solving; planning/organizing resource management.
- Ability to motivate, influence, and collaborate across all organizational levels.
- Ability to engage internal/external experts in scientific dialogue on study design, conduct, and data interpretation.
- Broad working knowledge of FDA requirements, clinical trial design/strategies; experience with FDA and/or global regulatory agencies.
- Knowledge of GCP, GPV, ICH guidelines, and applicable regulatory requirements.
- Ability to conceive and execute innovative clinical development approaches.
- Excellent written, communication, and interpersonal skills; proven success in multi-functional teams.
- Strong project planning, negotiation, presentation skills; ability to deliver creative, practical solutions.
- Ability to prioritize multiple work streams and make definitive decisions.
- Understanding of the scientific method and applying it to business needs with medical/scientific rationale.
- Ability to travel domestically and internationally; travel to New Haven, CT.
Pay Range:
- $184,000 - $245,000 base salary.
- Eligible for annual short-term incentive and annual long-term incentive (e.g., equity).
Application instructions:
- Learn more about total rewards at https://www.invivyd.com/careers/.
- In collaboration with Biometrics, Clinical Operations, Regulatory Affairs, and Medical Affairs, lead clinical trial conception, study design, protocols, medical monitoring, and medical interpretation.
- Provide clinical leadership and medical strategic input for program deliverables, including protocol sections (per CDP), data review, program-specific standards, clinical components of regulatory documents/registration dossiers, and publications (investigator brochures, briefing books, safety updates, submission dossiers, and responses to health authorities).
- Lead timely drafting of regulatory authority clinical responses.
- Provide medical review and approval of 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 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.
- Serve as a medical resource for design and interpretation of clinical and preclinical programs.
- Contribute to trial documents including 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 or drug development (pharma/biotech), preferably across phases I–IV.
- Experience with monoclonal antibodies or vaccines strongly preferred.
- Medical monitoring experience required.
- Hands-on participation in successful regulatory approvals required.
Required skills/knowledge:
- Critical thinking and problem-solving; planning/organizing resource management.
- Ability to motivate, influence, and collaborate across all organizational levels.
- Ability to engage internal/external experts in scientific dialogue on study design, conduct, and data interpretation.
- Broad working knowledge of FDA requirements, clinical trial design/strategies; experience with FDA and/or global regulatory agencies.
- Knowledge of GCP, GPV, ICH guidelines, and applicable regulatory requirements.
- Ability to conceive and execute innovative clinical development approaches.
- Excellent written, communication, and interpersonal skills; proven success in multi-functional teams.
- Strong project planning, negotiation, presentation skills; ability to deliver creative, practical solutions.
- Ability to prioritize multiple work streams and make definitive decisions.
- Understanding of the scientific method and applying it to business needs with medical/scientific rationale.
- Ability to travel domestically and internationally; travel to New Haven, CT.
Pay Range:
- $184,000 - $245,000 base salary.
- Eligible for annual short-term incentive and annual long-term incentive (e.g., equity).
Application instructions:
- Learn more about total rewards at https://www.invivyd.com/careers/.