Senior Director (Senior Principal Scientist), Translational Medicine, Immunology

MSD•Boston, MA

1d•Hybrid

About The Position

Translational Medicine within the Research & Development Division is responsible for planning and managing a critical phase in the drug development process. This involves collaborating with scientific, regulatory, statistical, and modeling colleagues to translate preclinical discovery into compounds ready for assessment in large clinical populations. The company is seeking a highly qualified physician-scientist with a proven track record in both the pharmaceutical industry and independent academic research. The Senior Principal Scientist title is equivalent to a Senior Medical Director position. The preferred candidate should have at least 5 years of experience in the pharmaceutical industry, with a focus on Immunology R&D, and clinical/academic expertise in Immunology-related areas such as Dermatology, Rheumatology, or Gastroenterology. While primary collaborations for the Immunology development pipeline are in Boston, MA, other locations like West Point, PA, Upper Gwynned, PA, Rahway, NJ, and San Francisco, CA are also open. Translational Medicine's specific responsibilities include contributing to novel target identification by integrating clinical insight with discovery research, executing clinical studies to validate targets, developing biomarker strategies from First-in-Human studies through clinical Proof-of-Concept (including Experimental Medicine studies), and developing/executing early clinical development strategies for novel Immunology programs from Preclinical Candidate approval through clinical Proof-of-Concept (Phase 2a). It also involves developing and executing clinical pharmacology strategies for late-stage development programs from Proof-of-Concept (Phase 2a) through worldwide marketing application. Success in this group relies on integrity, knowledge, imagination, creativity, skill, diversity, and teamwork, fostering an environment of mutual respect and encouragement. As part of the global team, the incumbent will collaborate with colleagues in Translational Medicine, Discovery Sciences, and late-stage Clinical Research. This role reports directly to the Immunology Therapeutic Area Lead in Translational Medicine.

Requirements

MD or MD/PhD
At least 5-year experience in the pharmaceutical industry in clinical research, preferrable in immunology clinical research, including translational research
An educational/career track including both independently conceived and executed research and clinical patient care experience
Proven track record in clinical research in the pharmaceutical industry
Proven track record in clinical care of patient populations or management of clinical problem-solving, preferably in Dermatology
Demonstrated record of scientific scholarship and achievement.
Strong interpersonal, writing and presentation skills, as well as the ability to function in a team environment are essential.

Nice To Haves

Research expertise in any immunology field is preferred.
Board Certification or Eligibility (MD and MD/PhD) preferred

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 Immunology assets and therapeutics including authoring initial clinical and biomarker plans for Lead Optimization programs, early clinical development plans for Preclinical Candidate molecules, Phase 1a/b trials and 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, 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 sites in the USA, UK and Belgium.