Principal Scientist, Nonclinical Drug Safety Program Discovery (Discovery Program Leader; Equivalent to Scientific Director)
Responsibilities:
- Represent Nonclinical Drug Safety (NDS) on discovery research teams and in scientific/strategic review meetings (primarily immunology and oncology).
- 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, de-risking strategies, and collaborate with NDS staff across sites to execute studies supporting therapeutic target selection and new drug candidate identification/development.
- Serve on development teams to define GLP toxicology study strategy/execution and contribute non-clinical safety sections of regulatory documents for clinical trials and worldwide marketing authorization.
- Participate in therapeutic area discovery governance reviews; promote innovative thinking from target identification/validation through lead optimization.
- Identify and assess risks using literature, internal, and external information; may lead early development teams to inform preclinical studies.
In This Role You Will:
- Represent NDS on discovery teams and governance committee reviews.
- Facilitate creative thinking across Immunology (primary) and also Oncology, Cardiometabolic, Infectious Disease, and/or Neuroscience.
- Influence cross-site disease-area and functional-discipline groups.
Qualifications:
- PhD (or DVM/MD or equivalent) in Toxicology, Pharmacology, Pathology, Biology, Biochemistry, Immunology, Pharmaceutical Sciences, Chemistry, or related STEM field.
- 8+ years pharmaceutical industry experience as non-clinical safety scientist and/or NDS safety assessment representative to cross-functional discovery/development teams.
- Ability to navigate cross-functional/matrix organizations and drive decision making.
- Strong collaboration, interpersonal skills, and communication; know when/how to raise issues.
Preferred:
- Background in immunology.
- Experience in biopharmaceutical/small molecule development and/or discovery.
- Experience with regulatory submissions and responses.
- Member of pharmaceutical consortia and/or external scientific/professional organizations.
Required Skills (examples):
- Adaptability, Strategic Thinking, Safety Evaluation, Toxicology, Drug Discovery Process, Drug Development, Immunology/Immunotherapy, Oncology, Innovative Thinking, Professional Collaboration/Networking.
Application instructions:
- Apply via https://jobs.merck.com/us/en (application deadline stated on posting).