Job Description

Our company, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its legacy for over a century. Our company's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

Our company is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Our Research Division is a true scientific research facility of tomorrow, and will take our company's leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.

We have an exciting opportunity for a Principal Scientist (Director) in Translational Pharmacology to be based in the US (PA or NJ). 

Translational Pharmacology at our Research Division 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. For our efforts supporting the neuroscience drug development pipeline, our closest collaborations are with groups based in West Point PA, Boston MA, and London UK. We are seeking a highly qualified individual for a position in our group. The preferred candidate will have expertise in Neuroscience/Neurology, but candidates with a strong background in basic and clinical translational research and desire to work collaboratively across different therapeutic areas are also sought.

Translational Pharmacology is specifically responsible for:

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 full development, that can be bridged into full development
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.
Development and execution of the early clinical development strategy for novel therapy programs from Preclinical Candidate approval through clinical Proof-of-Concept (Phase 2) Development and execution of clinical pharmacology strategies supporting late stage development programs from Proof-of-Concept (Phase 2) through worldwide marketing application.

Success depends on the integrity, knowledge, imagination, creativity, skill, diversity 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 Pharmacology, as well as Discovery Sciences and late stage Clinical Research while developing and expanding your career.

Individual will report directly to Neuroscience Therapeutic Lead of Translational Pharmacology.

Primary responsibilities for the Principal Scientist 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 Pharmacology Operations, Translational Pharmacology-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs, and late stage Clinical Research throughout sites in the USA, UK and Belgium.

Education:

MD or MD/PhD; or
PhD/PharmD; at least 10 years of drug development experience to include preclinical pharmacology, biomarker validation and development, and team management

Required:

Proven track record in clinical medicine or clinical research, and background in biomedical research.
Demonstrated record of scientific scholarship and achievement. Neuroscience expertise preferred, but a track record of excellence and a willingness to work collaboratively across different therapeutic areas with an emphasis on neuroscience drug development will be considered.
Strong interpersonal, writing and presentation skills, as well as the ability to function in a team environment are essential.
Board Certification or Eligibility (MD and MD/PhD) preferred
Prior specific experience in clinical research and prior publication preferably with experience in the area of basic, translational research and experience with early clinical development and patient care