Principal Scientist, Nonclinical Drug Safety Program Discovery
Responsibilities:
- Represent Nonclinical Drug Safety (NDS) on discovery research teams and in scientific/strategic review meetings focused on immunology and oncology.
- Define and oversee NDS strategy for programs across modalities (small molecules, peptides, biologics, ADCs) from Target Identification through approval of First-In-Human enabling GLP toxicity studies.
- Provide risk assessments for targets; develop de-risking strategies for discovery programs.
- Collaborate with NDS staff at other sites to execute appropriate studies supporting target selection and new drug candidate identification/development.
- Support development teams by defining GLP toxicology study strategy/execution and contributing non-clinical safety sections of regulatory documents for clinical trials and worldwide marketing authorization.
- Represent NDS in therapeutic area discovery governance committee reviews.
- Facilitate creative thinking from target identification/validation through lead optimization (primarily immunology; also oncology and other therapeutic areas).
- Identify and assess risks for therapeutic targets/development candidates using literature, internal data, and external information.
Qualifications:
- PhD (or equivalent) in Toxicology, Pharmacology, Pathology, Biology, Biochemistry, Immunology, Pharmaceutical Sciences, Chemistry, or related STEM; DVM or MD acceptable.
- 8+ years pharmaceutical industry experience as a non-clinical safety scientist and/or non-clinical safety assessment representative supporting cross-functional discovery/development teams.
- Demonstrated ability to drive decision-making in a matrix organization; creative problem solving and timely goal delivery.
- Strong collaboration, interpersonal, and communication skills.
Preferred:
- Immunology background.
- Experience in biopharmaceutical and/or small molecule discovery/development.
- Regulatory submissions/responses experience.
- Member of pharmaceutical consortia and/or external scientific/professional organizations.
Required skills: Adaptability; Drug Development; Drug Discovery Process; Safety Evaluation; Strategic Thinking; Toxicology; Innovative Thinking; Professional Collaboration; Professional Networking; Immunology; Immunotherapy; Oncology; Combination Products.
Application:
- Apply via https://jobs.merck.com/us/en (application deadline listed on posting). Requisition ID: R405119.