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

Overview

Senior Principal Scientist (Senior Medical Director) Translational Medicine, Immunology. Translational Medicine in our Research & Development Division plans and manages an important inflection point in the drug development process, working with scientific, regulatory, statistical, and modeling colleagues to translate 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. Our Senior Principal Scientist title is 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, and clinical/academic expertise in Immunology-related areas such as Dermatology, Rheumatology, or Gastroenterology.

The role supports Immunology development with close collaboration with groups based in Boston, MA, and is open to other locations including West Point, PA;
Upper Gwynedd, PA;
Rahway, NJ; and San Francisco, CA.

The position reports directly to the Immunology Therapeutic Area Lead in Translational Medicine.

• Contribute to the identification of novel targets by partnering with discovery research teams to bring clinical insight into early target identification and validation, and execute clinical studies to evaluate relevance of targets to human disease to justify investment in full development.
• Develop biomarker strategies through cross-functional teams to provide line-of-sight from First-in-Human studies through clinical Proof-of-Concept, including Experimental Medicine studies to establish/validate novel clinical biomarker platforms.
• Develop and execute the early clinical development strategy for novel Immunology therapies from Preclinical Candidate approval through clinical Proof-of-Concept (Phase 2a), and develop/executed clinical pharmacology strategies for late-stage programs from Proof-of-Concept (Phase 2a) through worldwide marketing application.
• Lead an early development team, designing and executing early clinical development strategy for Immunology assets and therapeutics, including authoring initial clinical and biomarker plans for Lead Optimization programs and Phase 1a/b trials.
• Develop and execute studies to validate clinical platforms utilizing established and novel biomarkers, including imaging and biomarkers that interrogate biological activity in humans.
• Provide clinical expertise for identification/validation of novel targets, including preclinical/clinical pharmacology study design to validate targets/pathways.
• Ensure safe and timely execution of Phase I studies with collaboration across internal/external study support staff and scientists (discovery research, biostatistics, drug metabolism, modeling & simulation, regulatory affairs, and global clinical trials operations).
• Provide clinical pharmacology support for programs through worldwide marketing applications, including supportive registration documents and presentations.
• Communicate study results clearly and timely 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 with key functions across sites in the USA, UK, and Belgium, 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.

• MD or MD/PhD
• At least 5 years of experience in the pharmaceutical industry in clinical research, preferably in immunology clinical research, including translational research
• 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; research expertise in immunology is preferred
• Strong interpersonal, writing and presentation skills; ability to function in a team environment
• Board Certification or Eligibility (MD and MD/PhD) preferred

Required:

Academic Research, Clinical Studies, Clinical Trial Development, Dermatology, Drug Development, Immunology, Gastroenterology, Rheumatology, Scientific Publications, Translational Research

Preferred/Additional notes:
Current Employees apply HERE. Current Contingent Workers apply HERE. US and Puerto Rico Residents Only. Our company is committed to inclusion and provides accommodations during the application/hiring process if needed. Equal…