Medical Director bei Invivyd
Invivyd · New Haven, Vereinigte Staaten Von Amerika · Hybrid
- Senior
- Optionales Büro in New Haven
ABOUT US
There are more than 9 million immunocompromised people in the United States. Almost half a million of those represent a population that are moderately to severely immunocompromised and at highest risk for severe COVID-19, including stem cell and solid organ transplant patients as well as those with hematologic cancers.
At Invivyd, Inc., we take those numbers very seriously and we come to work each day on a mission to deliver protection from serious viral infectious diseases, beginning with SARS-CoV-2. Invivyd deploys a proprietary integrated technology platform unique in the industry designed to assess, monitor, develop, and adapt to create best in class antibodies. In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody (mAb) in its pipeline of innovative antibody candidates.
Join an incredible team of innovators, disrupters, predictive modelers, and antibody engineers who embrace a shared sense of ownership, a passion to save lives, think boldly and creatively, take targeted risks, are unafraid of failure, and welcome change as a positive catalyst to new opportunities.
Be part of making a difference. Be part of Invivyd.
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 include, but are not limited to, the following:
- 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
Requirements:
- 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 “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 at least 1x a month
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.
