Provide medical leadership and strategic oversight for clinical development and medical governance associated with early stage studies, ensuring the highest standards of patient safety, data integrity, and scientific excellence.
Collaborate closely with internal stakeholders (including virology, pharmacology, biostatistics, and discovery science teams) as well as external partners (academic institutions, research collaboratives, and regulatory bodies) to design, execute, and interpret clinical studies.
Ensure that all study protocols, clinical study reports, and supplementary documents are developed and executed to support the assessment of a medicine’s potential efficacy, safety profile, and overall value to patients.
Lead the design and delivery of early development plans alongside executive leadership, confirming the data necessary to support the development of multiple early‐stage compounds.
Contribute to the development of study protocols, supplementary documents (e.g., study procedures manuals, reporting and analysis plans, protocol deviation management plans), and responses to regulatory queries.
Provide medical perspective on overall study conduct, procedures, and safety event management throughout the clinical trial lifecycle (from Phase 1–4).

A qualified physician (MD, DO) with a clinical fellowship in Infectious Diseases OR substantial experience in clinical development and/or clinical trials execution in Infectious Diseases.
5+ years of experience in drug development or community clinical trials, with hands-on experience from conceptual study design through data analysis and publication.
Experience in early drug development, in late-stage drug development to include familiarity with discovery processes, toxicology, drug metabolism, pharmacokinetics, IND enabling study requirements, virology (including resistance), biometrics and data management, and clinical pharmacology.

Senior Director, Clinical Development

Key skills