Medical Director, Evidence Generation Lead

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.

Invivyd is seeking a passionate and strategic Medical Director, Evidence Generation Lead with expertise in infectious or rare diseases and real-world evidence (RWE) to drive the development of monoclonal antibody therapies targeting SARS-CoV-2 and other high-priority infectious diseases. This role will lead the design, execution, and communication of evidence generation strategies that leverage real-world data (RWD), including registries, claims databases, and electronic health records (EHRs), to inform clinical, regulatory, and commercial decision-making.

The ideal candidate will collaborate cross-functionally with Medical Affairs, Clinical Development, Regulatory, and Commercial teams, as well as with external stakeholders, to shape and execute a robust evidence generation roadmap. This individual will play a critical role in establishing Invivyd as a scientific leader in infectious disease therapeutics.

Responsibilities include developing and updating the Evidence Generation Plans across various disease areas, managing research budgets, resources and timelines, implementing tactical activities, building relationships with key stakeholders, leveraging existing real-world datasets and claim databases to generate valuable insights for critical decision-making.  These insights will inform and shape medical, clinical and commercial strategies. 

The Medical Director will also be responsible for providing strategic insights to the executive leadership team, medical and commercial field teams, payor and clinical development teams, ensuring that information shared is timely, accurate, and fair-balanced.

Responsibilities:

• Build and maintain relationships with selected Key Opinion Leaders (KOLs), academic institutions, and research networks to identify evidence gaps, foster scientific collaboration and data sharing.
• Develop and maintain comprehensive Evidence Generation Plans aligned with corporate objectives across multiple disease areas including prioritization of data needs, managing the budget and timelines, overseeing the evidence generation committee and execution of the plans.
• Provide strategic input to executive leadership on data-driven insights that inform product development, market access, and lifecycle management.
• Collaborate with Clinical Development to support trial design and endpoint selection using historical and real-world cohorts.
• Work with Scientific Communications to disseminate findings through peer-reviewed publications, conference presentations, and internal reports.
• Ensure all evidence generation activities comply with GCP, regulatory standards, and internal SOPs.
• Represent Invivyd externally to establish the company as a leader in monoclonal antibody development for infectious diseases.
• Serve as an internal expert on clinical and scientific trends in infectious diseases and RWE methodologies.

Skills:

• Exceptional experience in claims analyses, medical affairs, and real-world evidence generation.
• Strong interpersonal abilities, enabling the establishment and maintenance of relationships with both internal and external stakeholders.
• Excellent communication skills—both written and verbal—with the ability to tailor messaging to diverse audiences.
• Ability to identify unmet medical, educational, and research needs at a local, regional, and national level in the medical community.
• Strong analytical and statistical acumen; ability to interpret complex datasets and translate into actionable insights.
• Strong organizational and project management skills; ability to manage multiple priorities in a fast-paced environment.
• Proficient in regulatory requirements and guidelines for medical research and evidence generation.
• High ethical standards and a commitment to maintaining scientific research integrity.

Requirements:

• Advanced degree (MD, PhD, PharmD) in a relevant field such as infectious diseases, immunology, epidemiology, or public health.
• Minimum of 5 years of experience in medical affairs, clinical research or epidemiology with a strong focus on RWE and data analytics.
• Demonstrated experience in designing and executing RWE studies, including claims and registry data analysis.
• Ability to clearly communicate complex information to colleagues and health care decision makers.
• Experience with new product launches and evidence generation to support market access and reimbursement.
• Knowledge of digital health tools and platforms for data collection and dissemination.
• Experience working in small biotech or startup environments with cross-functional collaboration.
• Experience in monoclonal antibody development or biologics in infectious diseases preferred.
• Familiarity with HTA and payer evidence requirements preferred.
• Ability to complete required training, documentation, expense reporting, and other administrative tasks
• Must conduct business activities in accordance with corporate policy and state/federal law with dedicated commitment to the fulfillment of all applicable SOPs, and regulations for compliance and quality
• Professional fluency in English

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.