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

Merck•Boston, MA

1d•$286,900 - $451,600•Hybrid

About The Position

Translational Medicine within the Research & Development Division is responsible for managing the drug development process, translating preclinical discovery into compounds ready for clinical assessment. The team collaborates with scientific, regulatory, statistical, and modeling colleagues. This position seeks a highly qualified physician-scientist with a proven track record in both the pharmaceutical industry and independent academic research, specifically with at least 5 years of experience in Immunology R&D and clinical/academic expertise in Immunology-related areas like Dermatology, Rheumatology, or Gastroenterology. Translational Medicine's responsibilities include identifying novel targets by providing clinical insight to discovery research, developing biomarker strategies from First-in-Human studies through clinical Proof-of-Concept, and executing early clinical development strategies for novel Immunology programs from Preclinical Candidate approval through Phase 2a, as well as clinical pharmacology strategies for late-stage development. Success in this global team relies on integrity, knowledge, imagination, creativity, skill, diversity, and teamwork, fostering an environment of mutual respect and encouragement.

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.
Academic Research
Clinical Studies
Clinical Trial Development
Dermatology
Drug Development
Gastroenterology
Immunology
Intellectual Curiosity
Pharmaceutical Research
Rheumatology
Scientific Publications
Scientific Research
Translational Research

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 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.