Associate Principal Scientist, Toxicology/Study Director
Merck
August 19, 2026
Remote friendly (West Point, PA)
United States
Clinical Research and Development
Key Responsibilities
- Serve as single point of control (Study Director) on assigned acute through chronic general toxicology studies across all modalities.
- Interact with technical, veterinary, and scientific staff to ensure study compliance with protocol, amendments, SOPs, regulations, safety guidelines, and company policies.
- Critically analyze and interpret data; integrate clinical pathology, pathology, toxicokinetics into regulatory submission reports; communicate results within established timelines.
- Ensure regulatory rigor, proactive risk identification, and timely study execution.
- Demonstrate enterprise mindset and strategic thinking; proactively identify opportunities/challenges and contribute solutions aligned with Nonclinical Drug Safety priorities.
- Build collaborative relationships and influence without authority; support inclusive team environment.
- Deliver high-quality results with accountability and agility; translate objectives into action and continuously improve.
- Lead and/or participate in method development, inter-group initiatives, and related scientific projects (as needed).
Education
- Master’s degree with training in toxicology, pharmacology, or related discipline.
Requirements
- Minimum 8 years relevant experience.
- Minimum 5 years as a Study Director in pharma, biotech, or CRO.
- GLP General Toxicology Study Director experience with varied models, routes, and study designs.
- Demonstrated understanding of GLP (US FDA 21 CFR Part 58).
- Strong interest in cross-functional collaboration and open communication.
- Strong listening and leadership skills.
- Ability to communicate clearly (verbal and written, including presentations).
Preferred
- GLP Study Director experience with varied modalities (e.g., biologics, small molecules).
- Familiarity with outsourced study monitoring.
- Familiarity with ICH safety guidelines.
Required Skills
Animal studies; effective written communication; evaluate information; GLPs; oral communications; proactive thinking; study directing; study monitoring; teamwork; toxicology.
Preferred Skills
- Current and contingent workers apply via “HERE.”
Application
- Apply at https://jobs.merck.com/us/en (deadline stated on posting).
- Serve as single point of control (Study Director) on assigned acute through chronic general toxicology studies across all modalities.
- Interact with technical, veterinary, and scientific staff to ensure study compliance with protocol, amendments, SOPs, regulations, safety guidelines, and company policies.
- Critically analyze and interpret data; integrate clinical pathology, pathology, toxicokinetics into regulatory submission reports; communicate results within established timelines.
- Ensure regulatory rigor, proactive risk identification, and timely study execution.
- Demonstrate enterprise mindset and strategic thinking; proactively identify opportunities/challenges and contribute solutions aligned with Nonclinical Drug Safety priorities.
- Build collaborative relationships and influence without authority; support inclusive team environment.
- Deliver high-quality results with accountability and agility; translate objectives into action and continuously improve.
- Lead and/or participate in method development, inter-group initiatives, and related scientific projects (as needed).
Education
- Master’s degree with training in toxicology, pharmacology, or related discipline.
Requirements
- Minimum 8 years relevant experience.
- Minimum 5 years as a Study Director in pharma, biotech, or CRO.
- GLP General Toxicology Study Director experience with varied models, routes, and study designs.
- Demonstrated understanding of GLP (US FDA 21 CFR Part 58).
- Strong interest in cross-functional collaboration and open communication.
- Strong listening and leadership skills.
- Ability to communicate clearly (verbal and written, including presentations).
Preferred
- GLP Study Director experience with varied modalities (e.g., biologics, small molecules).
- Familiarity with outsourced study monitoring.
- Familiarity with ICH safety guidelines.
Required Skills
Animal studies; effective written communication; evaluate information; GLPs; oral communications; proactive thinking; study directing; study monitoring; teamwork; toxicology.
Preferred Skills
- Current and contingent workers apply via “HERE.”
Application
- Apply at https://jobs.merck.com/us/en (deadline stated on posting).