Translational Medicine (Immunology) is responsible for early clinical development of novel therapeutics.
Translational Medicine Is Specifically Responsible For
- Leadership of early clinical development strategy (Preclinical Candidate approval through Phase 1 clinical pharmacology and Phase 2 proof-of-concept).
- Biomarker strategy development (including Experimental Medicine studies) from First-in-Human through Proof-of-Concept.
- Clinical perspective on target identification/validation and execution of clinical studies to assess relevance to human disease.
- Clinical pharmacology strategy development to support development through worldwide marketing application.
Primary Responsibilities
- Lead an early development team; design and execute early clinical development strategy.
- Author/execute early clinical and biomarker plans and clinical pharmacology studies (Phases IβIV).
- Validate clinical platforms using established/novel biomarkers, including imaging, electrophysiological and behavioral readouts.
- Provide clinical expertise for novel target/pathway identification and validation.
- Safe/timely Phase I execution; collaborate with cross-functional teams.
- Provide clinical pharmacology support for worldwide marketing application (registration documents and presentations).
- Communicate and interpret study results to governance and review committees.
- Interface with key functions across global research sites.
Education
- MD or MD/PhD.
Required
- Track record in clinical medicine or clinical research; biomedical research background.
- Scientific scholarship (publications/presentations) and collaborative mindset.
- Strong interpersonal, writing, and presentation skills.
Preferred
- Clinical Board Certification or eligibility; translational/early clinical development experience.