Principal Scientist (Director), Translational Medicine - Cardiovascular

About the role

Translational Medicine is responsible for early clinical development of novel therapeutics, working in close collaboration with Discovery Sciences and late-stage Clinical Research. The role works across all therapeutic areas within the Research Division with a focus on Cardiovascular Disease and related conditions. The Principal Scientist (Clinical Director) must have a strong background in basic and/or clinical translational research and a desire to work collaboratively across different therapeutic areas.

Responsibilities

• Leadership of the early clinical development strategy for novel therapy programs from Preclinical Candidate approval through Clinical Pharmacology testing (Phase 1) and clinical Proof-of-Concept (Phase 2).
• Development of biomarker strategies through cross‑functional teams that provide line‑of‑sight from First‑in‑Human studies through clinical Proof‑of‑Concept, including Experimental Medicine studies to establish and/or validate biomarker platforms.
• Contributing to the identification of novel targets by partnering with discovery research teams to bring a clinical perspective into the earliest stages of target identification and validation, and executing clinical studies to evaluate the relevance of potential targets to human disease to justify investment in clinical development programs.
• Development and execution of clinical pharmacology strategies to support later stages of development from Proof‑of‑Concept (Phase 2) through worldwide marketing application.
• Provide clinical expertise for identification and validation of novel targets, including the design of preclinical and/or clinical pharmacology experiments to validate targets and/or pathways.
• 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).
• Provide clinical pharmacology support for programs through the worldwide marketing application filing including supportive registration documents and presentations.
• Provide clear, timely communication and interpretation of study results to therapeutic area governance, functional area experts and development review committees.
• Contribute to assessment of internal and external opportunities identified by Business Development and Licensing.
• Interface broadly with key functions including Discovery Sciences, Preclinical Pharmacology, Pharmaceutical Sciences, Toxicology, Translational Biomarkers, Translational Medicine Operations, Translational Medicine‑EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs, and late‑stage Clinical Research throughout research sites around the world.

Qualifications

• MD or MD/PhD required.
• Proven track record in clinical medicine or clinical research, and background in biomedical research