Medical Director, Early-Stage Clinical Development

As an organization whose mission is to translate science into global public health impact, working on vaccines and therapeutics, IAVI has a vaccine policy which states that subject to applicable law, we require all U.S. and Puerto Rico based employees to be vaccinated for COVID-19, unless they have an approved medical or religious exemption or accommodation. We are committed to supporting our employees during this process as we work to ensure a safe and healthy work environment.

Position Description

Job Title:      Medical Director, Early-Stage Clinical Development
Location:      New York, NY Preferred, US-remote considered
Reports to:   Vice President and Head of Clinical Development

Position Summary:

Are you an experienced early development clinical Leader, who is eager to help translate science into global health solutions?

IAVI is seeking a Medical Director to lead a Clinical Development Matrix Team working on IAVI’s early-stage product development programs, which include vaccines and biologics (e.g., monoclonal antibodies) developed by IAVI or insourced from co-development partners. The Medical Director will design and strategize Phase 1 and 2 clinical protocols and ensure clinical trial sites are executing studies with the highest standards of scientific integrity, safety, and ethics. The Medical Director, who will have substantial early-stage product development experience will serve as a scientific liaison with pre-clinical development teams, ultimately helping to advance candidates into the clinic.

Key Responsibilities:

• Serves as Clinical Development Lead for IAVI’s early-stage vaccine or biologics development programs.
• Develops the integrated Clinical Development Plan ensuring all activities required for the preparation and execution of early-stage clinical trials are included to support eventual product access and delivery.
• Develops clinical trial strategies and collaborates with Regulatory Affairs and Clinical Operations for implementation of plans and procedures for clinical trial activities.
• Provides medical oversight of clinical protocols, consent forms, data collection instruments, and preparation of suitable educational materials and regulatory documents.
• Ensures that the Investigator Brochure/Investigational Medical Product Dossier (or equivalent) is complete and updated on an annual basis.
• Provides advice to preclinical groups on the design of studies and their relationship to the overall clinical development plan, as appropriate.
• Responsible for designing the clinical strategy that will generate data required for design of POC and Phase 3 efficacy trials that are appropriate to the target populations.
• Responsible for designing clinical research studies that generate data and clinical specimens that may elucidate the natural history, pathogenesis, and immune control of infection relevant for vaccine design and efficacy endpoints.
• Contributes to scientific assessments of internal and external candidate vaccines or biologics that IAVI might wish to consider and provides expert medical opinion and risk assessments required for prioritization and selection for further development.   
• Leads communication with Principal Investigators responsible for conduct of early-stage trials and with the medical representatives of external product developers as required.
• Collaborates with Biostatistics, Safety, and Regulatory Affairs to ensure timely development of statistical analysis plans occurs and leads conduct of the interim and final analysis meetings.
• When required, serves blinded Medical Monitor for selected clinical trials, including working with site investigators to collect and interpret data required by the Safety/PV team for assessment of product safety.
• Prepare interim and final Clinical Study Reports in collaboration with site investigators and other members of IAVI Departments, collaborating with site investigators to collect, analyze and report the data from studies at scientific meetings and through publications.
• Supports the Impact Area Lead responsible for strategic planning for portfolio expansion and clinical trials to evaluate novel products.

Other duties 

• Contribute to development of grant applications and reports for donors and granting agencies, in collaboration with the IAVI Development group.
• Contribute to development and reviewing of scientific and medical content of IAVI documents such as the IAVI Report and other IAVI educational materials.
• Represent IAVI at scientific meetings, including delivering oral presentations and posters.
• Maintain in-depth medical/scientific knowledge about the assigned therapeutic area or product, in