Position Overview

The Associate Medical Director, Clinical Development will play a key role in advancing clinical programs by contributing to clinical strategy, study design and execution, data interpretation, and development of clinical and regulatory documents. Working cross-functionally with Clinical Operations, Biostatistics, Regulatory Affairs, Pharmacovigilance, and other teams, this individual will help translate scientific insights into strong clinical evidence and meaningful program decisions.

This individual contributor role offers significant ownership and the opportunity to influence clinical development strategy while working closely with cross-functional leaders.

Essential Functions

• Provide scientific leadership for and contribute to the clinical development strategy and plans for vaccine and prophylactic monoclonal antibody candidates from early-stage development through later-stage clinical studies.
• Lead and support the design, implementation, execution, and interpretation of Phase 1–3 clinical trials, as applicable.
• Author clinical study protocols, protocol amendments, informed consent materials, clinical study reports, investigator brochures, statistical analysis plans, and other clinical and regulatory documents.
• Provide scientific input into study objectives, endpoints, eligibility criteria, schedules of assessments, immunogenicity evaluations, and exploratory biomarker strategies.
• Review emerging clinical data to evaluate safety, tolerability, immunogenicity, efficacy, and overall benefit-risk.
• Lead ongoing medical and scientific data review, including review of listings, tables, figures, laboratory results, adverse events, protocol deviations, and other clinical trial data.
• Partner closely with Biostatistics and Data Management on data analysis, interpretation, and presentation.
• Work with Clinical Operations to support high-quality study execution, including investigator and site engagement, study training, enrollment strategies, and resolution of scientific or clinical study issues.
• Conduct field assessments of clinical trial progress, including travel to investigative sites and endemic areas, as needed, to evaluate study execution, patient populations, and enrollment of appropriate high-risk populations.
• Collaborate with laboratory partners on immunologic assays and interpretation of humoral and cellular immune-response data, as appropriate to the program.
• Contribute to regulatory submissions and interactions with regulatory authorities, including briefing documents, responses to information requests, and clinical sections of INDs/BLAs or other applicable submissions.
• Support preparation of abstracts, posters, presentations, manuscripts, and other scientific communications describing clinical program results.
• Monitor relevant scientific literature, competitive programs, regulatory guidance, epidemiology, and advances in vaccinology and infectious diseases.
• Develop effective relationships with investigators, key opinion leaders, external experts, CROs, laboratories, and other development partners.
• Contribute to cross-functional program and study teams and communicate clinical findings, risks, and recommendations clearly to internal stakeholders.
• Serve as a clinical development scientific lead for assigned studies or programs, integrating clinical, operational, statistical, safety, and regulatory perspectives to support program-level decision-making.
• Maintain high standards of scientific rigor, data integrity, GCP compliance, and patient safety.

Necessary Skills and Abilities

• Strong scientific foundation in vaccinology, immunology, infectious diseases, or a related scientific or medical discipline.
• Ability to critically analyze complex clinical and scientific datasets and translate findings into clear conclusions and recommendations.
• Excellent organizational skills with the ability to manage multiple priorities and deliver high-quality work within timelines.
• Strong interpersonal and collaboration skills, with the ability to work effectively across scientific, clinical, operational, and regulatory functions.
• Comfortable operating in a fast-paced biopharmaceutical environment, with the ability to roll up your sleeves, work hands-on, and adapt as priorities evolve
• High attention to detail, intellectual curiosity, sound scientific judgment, and commitment to patients and rigorous clinical research.
• Willingness and ability to travel up to 20% to clinical trial sites and endemic areas to assess study progress, engage with investigators and site teams, and provide clinical and scientific insight to support enrollment of appropriate high-risk patient populations.

Educational Requirements

• PhD, PharmD, MD, or equivalent advanced degree in a relevant scientific or medical discipline required. MD preferred but not required.

Experience Requirements

• 5+ years of relevant clinical development experience within the biotechnology or pharmaceutical industry.
• Demonstrated clinical development experience, including direct experience supporting vaccine clinical development.
• Experience leading and providing scientific oversight for clinical trials, including study design, execution, data review, and interpretation.
• Strong understanding of clinical endpoints, statistical concepts, and benefit-risk assessment, with experience applying these principles to large clinical trials.
• Experience with vaccine, infectious disease, and/or prophylactic monoclonal antibody clinical development preferred.
• Experience reviewing and interpreting clinical datasets and contributing to clinical protocols, study reports, regulatory documents, publications, or presentations.
• Strong understanding of clinical trial methodology, GCP, and the drug/biologic development process.
• Experience working on cross-functional clinical development teams.
• Familiarity with immunogenicity assessments, including antibody and/or cellular immune-response measurements, preferred.