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

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

Translational Medicine in our Research & Development Division is responsible for planning and managing an important inflection point in the drug development process, working closely with scientific, regulatory, statistical, and modeling colleagues across the organization to translate the benchtop science of preclinical discovery into compounds ready for assessment in large clinical populations.

We are seeking a highly qualified physician-scientist with a proven track record in both the pharmaceutical industry and independent academic research for a position in our group. Please note that our Senior Principal Scientist title is also equivalent to a Senior Medical Director position.

The preferred candidate will have at least 5 years of experience in the pharmaceutical industry, with a focus on Immunology R&D, as well as clinical and academic expertise in Immunology-related areas such as Dermatology, Rheumatology, or Gastroenterology.

For our efforts supporting the Immunology development pipeline, our closest collaborations are with groups based in Boston, MA; however, we will also be open to other locations, including West Point, PA, Upper Gwynned, PA, Rahway, NJ, and San Francisco, CA.

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/Immunology 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.

This role will report directly to the Immunology Therapeutic Area Lead in Translational Medicine.

Primary responsibilities for the Senior Director (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 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.

Position Qualifications :

• Education Minimum Requirement
• MD or MD/PhD
• At least 5-year experience in the pharmaceutical industry in clinical research, preferable in immunology clinical research, including translational research
• An educational/career track including both independently conceived and executed research and clinical patient care experience
• Required Experience and Skills:
• 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. Research expertise in any immunology field is preferred.
• 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
• Required Skills:
• Academic Research, Clinical Studies, Clinical Trial Development, Dermatology, Drug Development, Gastroenterology, Immunology, Intellectual Curiosity, Pharmaceutical Research, Rheumatology, Scientific Publications, Scientific Research, Translational Research
• Preferred Skills: