Principal Scientist, Toxicologist/Study Director
Merck
June 25, 2026
On-site
West Point, PA
Clinical Research and Development
Principal Scientist, Toxicologist/Study Director
Key Responsibilities
- Serve as Study Director (single point of control) for assigned acute through chronic general toxicology studies across all modalities; ensure compliance with protocol/amendments, SOPs, regulations, safety guidelines, and company policies.
- Critically analyze and interpret data; integrate clinical pathology, pathology, and toxicokinetics into written reports for regulatory submissions; communicate results on timeline.
- Ensure regulatory rigor, proactive risk identification, and timely study execution.
- Participate on cross-functional teams to investigate mechanisms of toxicity.
- Represent nonclinical safety on product development teams; oversee strategy/design of nonclinical safety studies and develop regulatory strategies and communications with global agencies.
- Demonstrate enterprise mindset and strategic thinking; collaborate to deliver solutions and contribute to an inclusive environment.
- Deliver high-quality results with accountability and agility; continuously improve and support larger initiatives.
Education
- PhD and/or DVM with graduate/post-graduate training in toxicology, pharmacology, or related discipline.
Requirements
- 8+ years as a Toxicologist or Study Director in pharma/biotech/CRO.
- Demonstrated experience with GLP (US FDA 21 CFR Part 58).
- Strong collaboration and communication across cross-functional teams; leadership and mentoring.
- Clear verbal and written communication (presentations/meetings).
- Expertise in immunology and/or biologics, including regulatory requirements and testing.
Preferred
- Knowledge of biotherapeutics/large-molecule drug development strategies.
- Experience with outsourced study monitoring.
- Toxicology expert on drug discovery/development teams.
- Representation of nonclinical safety in regulatory agency interactions.
Key Responsibilities
- Serve as Study Director (single point of control) for assigned acute through chronic general toxicology studies across all modalities; ensure compliance with protocol/amendments, SOPs, regulations, safety guidelines, and company policies.
- Critically analyze and interpret data; integrate clinical pathology, pathology, and toxicokinetics into written reports for regulatory submissions; communicate results on timeline.
- Ensure regulatory rigor, proactive risk identification, and timely study execution.
- Participate on cross-functional teams to investigate mechanisms of toxicity.
- Represent nonclinical safety on product development teams; oversee strategy/design of nonclinical safety studies and develop regulatory strategies and communications with global agencies.
- Demonstrate enterprise mindset and strategic thinking; collaborate to deliver solutions and contribute to an inclusive environment.
- Deliver high-quality results with accountability and agility; continuously improve and support larger initiatives.
Education
- PhD and/or DVM with graduate/post-graduate training in toxicology, pharmacology, or related discipline.
Requirements
- 8+ years as a Toxicologist or Study Director in pharma/biotech/CRO.
- Demonstrated experience with GLP (US FDA 21 CFR Part 58).
- Strong collaboration and communication across cross-functional teams; leadership and mentoring.
- Clear verbal and written communication (presentations/meetings).
- Expertise in immunology and/or biologics, including regulatory requirements and testing.
Preferred
- Knowledge of biotherapeutics/large-molecule drug development strategies.
- Experience with outsourced study monitoring.
- Toxicology expert on drug discovery/development teams.
- Representation of nonclinical safety in regulatory agency interactions.