Principal Scientist, Nonclinical Drug Safety Program Discovery (Discovery Program Leader)
In This Role You Will
- Represent Nonclinical Drug Safety (NDS) on discovery teams and participate in therapeutic area discovery governance committee reviews.
- Promote and facilitate creative thinking from target identification/validation through lead optimization (primarily Immunology; also Oncology, Cardiometabolic, Infectious Disease, and/or Neuroscience).
- Serve as a βdrug creatorβ by influencing cross-site disease area groups and functional disciplines.
- Identify and assess risks associated with therapeutic targets or development candidates using literature, internal, and external information.
- May lead early development teams by informing preclinical studies to support product development.
Responsibilities
- Define and oversee NDS strategy for programs across all modalities (small molecules, peptides, biologics, ADCs) from Target Identification through approval of First-In-Human enabling GLP toxicity studies.
- Provide target risk assessments; develop de-risking strategies for discovery programs.
- Collaborate with NDS staff at other sites to execute studies supporting therapeutic target selection and new drug candidate identification/development.
- May define GLP toxicology study strategy/execution on development teams and contribute to non-clinical safety sections of regulatory documents for clinical trials and marketing authorization.
Qualifications, Skills and Experience Needed
- PhD (Toxicology/Pharmacology/Pathology/Biology/biochemistry/Immunology/Pharmaceutical Sciences/Chemistry or related STEM) or DVM/MD or equivalent.
- 8+ years pharmaceutical industry experience as a non-clinical safety scientist and/or non-clinical safety assessment representative to discovery/development teams.
- Ability to navigate cross-functional, matrix organizations and drive decision-making.
- Strong collaboration, interpersonal skills, resilience, and communication.
Preferred Experience/Skills
- Immunology background.
- Experience in biopharmaceutical and small molecule discovery/development.
- Regulatory submission/response experience.
Required Skills: Adaptability, Drug Development, Drug Discovery Process, Strategic Thinking, Safety Evaluation, Toxicology, Professional Collaboration/Networking, Innovative Thinking, Immunology/Immunotherapy, Oncology.
Application instructions: Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees).