Principal Scientist (Director), Translational Medicine - Cardiovascular
Merck · Boston, MA · 1 mo ago
$260k–$410k/yrFull-time
About the role
The Principal Scientist (Clinical Director) leads early clinical development strategy for novel therapeutics with a focus on Cardiovascular Disease and related conditions. Working closely with Discovery Sciences and late-stage Clinical Research, the role drives biomarker strategies, target identification, and clinical pharmacology plans from preclinical candidate approval through Phase I/II proof‑of‑concept and beyond, fostering a collaborative, respectful, and innovative team environment.
Responsibilities
- 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.
Requirements
- 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.
- Strong interpersonal, writing and presentation skills, and ability to function in a team environment.
Qualifications
- Clinical Board Certification or eligibility (preferred).
- Subspecialty clinical and research experience in Cardiology or a related subspecialty (e.g., nephrology, pulmonary) (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
- Cardiology
- Cardiovascular Medicine
- Clinical Trials
- Nephrology
- Scientific Research
- Translational Medicine
- Translational Research
Benefits
We offer a comprehensive package of benefits including medical, dental, vision and other insurance (employee and family), retirement benefits such as