Job Description
Translational Medicine at our Research & Development Division is responsible for planning and management of an important inflection point in the drug development process, working closely with scientific, regulatory, statistical, and modelling colleagues across the organization to translate the benchtop science of preclinical discovery into compounds ready for assessment in large clinical populations.
For our efforts supporting the vaccine development pipeline, our closest collaborations are with groups based in West Point PA, Upper Gwynned, PA, Rahway, NJ and Boston MA. We are seeking a highly qualified individual with a proven track record of both independent research and recent clinical experience for a position in our group.
The preferred candidate will have expertise in vaccine-related areas such as Infectious Diseases/Pediatrics, Preventative Medicine/Immunology/Microbiology, 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 Medicine is specifically responsible for:
Contributing to the identification of novel targets by partnering with discovery research teams to bring a clinical insight 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.
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 novel clinical 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 2a), and development and execution of clinical pharmacology strategies for late-stage development programs from Proof-of-Concept (Phase 2a) 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 Medicine, as well as Discovery Sciences and late-stage Clinical Research while developing and expanding your career.
Individual will report directly to Vaccine Therapeutic Lead of Translational Medicine.
Primary responsibilities for the Principal Scientist/Senior 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 vaccines and therapeutics including authoring initial clinical and biomarker plans for Lead Optimization programs, early clinical development plans for Preclinical Candidate molecules and vaccines, Phase 1 vaccine 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.
Education Minimum Requirement
Required Experience and Skills:
Proven track record in clinical care of patient populations or management of clinical problem-solving, preferably in a vaccine-related clinical field such as Internal Medicine, Infectious Diseases, Obstetrics-Gynecology, Family Medicine, or Pediatrics.
Demonstrated record of scientific scholarship and achievement. Research expertise in Infectious Diseases, Immunology or Microbiology is preferred, but a track record of research 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.
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