Associate Principal Scientist, Toxicology/Study Director

Merck & Co.; West Point (PA); On-site; USD 140,000 - 190,000; Full time

Job summary

Merck & Co. is seeking a senior toxicologist to lead and monitor nonclinical safety studies. The role involves serving as Study Director/Monitor, directing in vivo toxicology work, and integrating findings into safety reports for regulatory submissions.

The candidate will collaborate with cross-functional teams, ensure protocol and regulatory compliance, and drive timely study conclusions across acute to chronic studies. A strong GLP background and leadership in toxicology are essential.

Qualifications

• Master’s degree in toxicology, pharmacology, or related field.
• 8+ years of relevant experience.
• GLP Study Director experience or equivalent.
• Understanding of Good Laboratory Practices (US FDA 21 CFR Part 58).
• Strong collaboration and communication skills.

Responsibilities

• Serve as the single point of control (Study Director) on acute through chronic toxicology studies across modalities.
• Interact with technical, veterinary, and scientific staff to ensure study compliance with protocol, SOPs, regulations, and company policies.
• Critically analyze and interpret data; integrate findings into regulatory submissions and reports.
• Ensure regulatory rigor, proactive risk identification, and timely study execution.
• Demonstrate enterprise mindset, strategic thinking, and cross-functional collaboration.
• Build strong collaborative relationships and influence without authority within an inclusive team environment.
• Deliver high-quality results with accountability and agility, translating objectives into action.
• As needed, lead or participate in method development and related scientific projects.

Skills

Animal Studies

Effective Written Communications

Evaluate Information

Good Laboratory Practices (GLPs)

Oral Communications

Proactive Thinking

Study Directing

Study Monitoring

Teamwork

Toxicology

Education

Master's degree in toxicology, pharmacology, or related discipline

Job description

Job Description

The Nonclinical Drug Safety department 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 at our Company are integral members and leaders of collaborative cross functional scientific teams, addressing challenges from early discovery to late development. Our toxicologists provide scientific leadership in the design and overall conduct -of in - vivo studies and integrate the findings from all contributing scientists into reports that characterize the safety profile of drug candidates. -

Key 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 that the study - is in compliance with - the protocol, amendments, Standard Operating Procedures, regulations, safety guidelines, and company policies and procedures.
• Critically analyze and interpret data. Integrate data from other areas (e.g., clinical pathology, pathology, - toxicokinetics ) in written reports used for regulatory - submissions, and - communicate results within established timelines.
• E nsure 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 - Nonclinical Drug Safety - organizational priorities.
• Build strong - collaborative relationships and influences without authority, contributing to an inclusive team environment.
• Deliver high-quality results with accountability and agility, translating objectives into action while continuously improving , - embracing change, and - demonstrating leadership .
• As needed, lead and/or participate in method development, inter-group initiatives, and various related scientific projects.

Education

• Master 's degree - with training in toxicology, pharmacology, or related scientific discipline .

Requirements

• 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 Direct or - 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 and often with colleagues .
• Strong listening - and leadership - skills .
• Ability to communicate clearly using verbal and written formats , including presentations .

Preferred

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

Required Skills

Animal Studies, Effective Written Communication, Evaluate Information, Good Laboratory Practices (GLPs), Oral Communications, Proactive Thinking, Study Directing, Study Monitoring, Teamwork, Toxicology

US and Puerto Rico Residents Only

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

San Francisco Residents Only

-We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only

-We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Employee Status

Regular

Relocation

Domestic

VISA Sponsorship

No

Travel Requirements

No Travel Required

Flexible Work Arrangements

Not Applicable

Shift

Not Indicated

Valid Driving License

No

Hazardous Material(s)

N/A

Job Posting End Date

09/30/2026

*A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID

R413396