Senior Principal Scientist – Translational Medicine – Immunology
| Company | Inventing for Life |
|---|---|
| Location | Boston, MA, USA, North Wales, PA, USA, San Bruno, CA, USA, Linden, NJ, USA |
| Salary | $281300 – $442800 |
| Type | Full-Time |
| Degrees | PhD, MD |
| Experience Level | Senior |
Requirements
- MD or MD/PhD
- At least 5-year experience in the pharmaceutical industry in clinical research, preferable in immunology clinical research, including translational research
- 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.
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 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.
Preferred Qualifications
- Board Certification or Eligibility (MD and MD/PhD) preferred
- Research expertise in any immunology field is preferred.