Associate Principal Scientist, Toxicology/Study Director

Nonclinical Drug Safety is seeking a motivated and talented toxicologist to conduct and/or monitor toxicity studies (GLP and non-GLP) as a Study Director or Study Monitor. Toxicologists are integral members and leaders of collaborative cross-functional scientific teams, addressing challenges from early discovery to late development. They provide scientific leadership in the design and conduct of in vivo studies and integrate findings into reports that characterize the safety profile of drug candidates.

Responsibilities

• Serve as the 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 the protocol, amendments, Standard Operating Procedures, regulations, safety guidelines, and company policies.
• Critically analyze and interpret data, integrating data from clinical pathology, pathology, and toxicokinetics into written reports for regulatory submissions.
• Communicate results within established timelines, ensuring regulatory rigor, proactive risk identification, and timely study execution.
• Demonstrate enterprise mindset and strategic thinking, proactively identifying opportunities, anticipating challenges, and contributing to solutions aligned with organizational priorities.
• Build strong collaborative relationships, influencing without authority and contributing to an inclusive team environment.
• Deliver high-quality results with accountability and agility, translating objectives into action while continuously improving and embracing change.
• Lead and/or participate in method development, inter-group initiatives, and related scientific projects as needed.

Requirements

• Master’s degree in toxicology, pharmacology, or a related scientific discipline.
• Minimum of 8 years of relevant experience.
• Minimum of 5 years as a Study Director in pharma, biotech, or at a CRO.
• General toxicology GLP Study Director experience with varied models, routes of administration, and study designs.
• Demonstrated understanding of Good Laboratory Practices (US FDA 21 CFR Part 58).
• Strong interest in collaborating with diverse cross-functional teams and communicating openly with colleagues.
• Strong listening and leadership skills.
• Ability to communicate clearly using verbal and written formats, including presentations.

Preferred Qualifications

• GLP Study Director experience with varied modalities (e.g., biologics and small molecule therapeutics).
• Familiarity with outsourced study monitoring.
• Familiarity with ICH safety guidelines.

Skills

• Required: Animal Studies, Effective Written Communication, Evaluate Information, Good Laboratory Practices (GLPs), Oral Communications, Proactive Thinking, Study Directing, Study Monitoring, Teamwork, Toxicology.
• Preferred: Experience with biologics and small molecule therapeutics, outsourced study monitoring, ICH safety guidelines.

Pay

The salary range for this role is $142,400.00 – $224,100.00. An employee’s position within the salary range will be based on factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits including 401(k), paid holidays, vacation, and compassionate and sick days. More information is available at Merck Compensation and Benefits.

Employee Status: Regular. Relocation: Domestic. VISA Sponsorship: Not available. Travel Requirements: No travel required.