Principal Scientist (Director), Translational Medicine - Cardiovascular

Job Description

Description of Position

Translational Medicine is responsible for early clinical development of novel therapeutics, working in close collaboration with Discovery Sciences and late-stage Clinical Research. We work with all therapeutic areas within our Research Division with the role focused 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.

Translational Medicine is specifically responsible for:

• 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. This includes 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 in order 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.

Success depends on the integrity, knowledge, imagination, creativity, skill and teamwork of the people in the group. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork. As part of the global team, you will collaborate with talented and dedicated colleagues in Translational Medicine, as well as Discovery Sciences and late-stage Clinical Research while developing and expanding your career.

Primary responsibilities include the following:

• Key member of an early development team, providing leadership in designing and executing early clinical development strategy.
• Development and execution of early clinical strategy for novel therapeutics including authoring initial clinical and biomarker plans for Lead Optimization programs, early clinical development plans for Preclinical Candidate molecules, and clinical pharmacology studies for programs in Phases I through IV of development.
• Development and execution of studies to validate clinical platforms utilizing established and novel biomarkers, including imaging, electrophysiological and behavioral responses to interrogate biological activity in humans.
• 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.

Education:

MD or MD/PhD

Required:

• Proven track record in clinical medicine or clinical research, and background in biomedical research.
• Demonstrated record of scientific scholarship and achievement including publications or presentations. The particular clinical or scientific background is less important than having a track record of excellence and a 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.

Preferred:

• Clinical Board Certification or Eligibility. Subspeciality Clinical and Research experience in Cardiology or a related subspeciality (e.g. nephrology, pulmonary) is preferred but not required.
• Prior experience in translational research and/or early clinical development preferred but not required.
• Proven track record in clinical care of patient populations or management of clinical problem-solving

Required Skills:

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