About this role
Associate Director/Director, Translational Medicine & Clinical Pharmacology
Translational Medicine in the Development group is responsible for early clinical development of novel therapeutics, working in close collaboration with nonclinical and clinical functional areas. The individual will work with all therapeutic areas within the Development Division. Candidates should have prior experience in basic and/or clinical research and a desire to work collaboratively across different therapeutic areas.
Responsibilities
- Contribute to development and execution of early clinical strategy for novel therapeutics including authoring initial clinical biomarker plans, early clinical development plans, and clinical pharmacology studies for programs in Phases I through IV of development
- Contribute to the development and execution of clinical pharmacology strategies
- Participate in the early clinical development strategy for novel therapy programs from preclinical candidates through initial clinical testing (Phase 1) and clinical Proof-of-Concept (Phase 2)
- Participate in the development of biomarker strategies through cross-functional teams that provide line-of-sight from First-in-Human studies through clinical Proof-of-Concept.
- Safe and timely execution of Phase I studies; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations)
- Medical responsibility for study protocol development, study and site feasibility process, site selection, , informed consent development, study set-up, medical oversight during study conduct, interpretation of study results and authorship of study report.
- Provide clear, timely communication and interpretation of study results to functional area experts and governance/senior management
- Interface broadly with key functions including discovery sciences, preclinical development groups, toxicology, clinical operations, drug metabolism, regulatory affairs, and late-stage clinical research
Qualifications
- MD/PhD or MD
- Clinical Board Certification preferred
- Proven track record in clinical medicine, clinical or basic research, and background in biomedical research
- Demonstrated record of scientific scholarship and achievement, willingness to work collaboratively across different therapeutic areas.
- Strong interpersonal, writing and presentation skills, as well as the ability to function in a team environment are essential