Associate Principal Scientist, Toxicology/Study Director

MSD; Upper Gwynedd Township (Montgomery County); On-site; USD 140,000 - 190,000; Full time

Job summary

Merck & Co., Inc. in Rahway, NJ invites a motivated toxicologist to lead and monitor GLP and non-GLP toxicity studies as Study Director or Study Monitor. You will guide study design, data interpretation, and reporting to support regulatory submissions.

Requirements include a Master’s in toxicology or related field and 8+ years of experience, with at least 5 years as a Study Director. Strong leadership and communication skills are essential.

Qualifications

• 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.
• Understanding of Good Laboratory Practices (US FDA 21 CFR Part 58).
• Strong collaboration and communication skills across cross-functional teams.
• Strong listening and leadership skills.
• Clear verbal and written communication, including presentations.

Responsibilities

• Serve as the Study Director on acute through chronic general toxicology studies across modalities.
• Interact with technical staff to ensure study compliance with protocol, SOPs, and safety guidelines.
• Critically analyze and interpret data; integrate pathology, toxicokinetics, and clinical pathology into regulatory reports.
• Ensure regulatory rigor, risk identification, and timely study execution.
• Demonstrate strategic thinking and cross-functional collaboration to address priorities.
• Lead or participate in method development and related scientific projects.

Skills

Animal Studies

Effective Written Communication

Evaluate Information

GLP Practices

Oral Communications

Proactive Thinking

Study Directing

Study Monitoring

Teamwork

Toxicology

Education

Master’s degree with training in toxicology

Job description

Job Description

The Nonclinical Drug Safety department is seeking amotivated and talentedtoxicologistto 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 conductof invivo 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 allmodalities.Interactwith technical, veterinary, and scientific staff to ensure that the studyis in compliance withthe 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 regulatorysubmissions, andcommunicate results within established timelines.
• Ensure 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 withNonclinical Drug Safetyorganizational priorities.
• Build strongcollaborative 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, anddemonstrating leadership.
• As needed, lead and/or participate in method development, inter-group initiatives, and various related scientific projects.

Education

• Master’s degreewith training in toxicology, pharmacology, or related scientific discipline.

Requirements

• Minimum of8years of relevant experience.
• Minimum of 5 yearsas a Study Director in pharma, biotech, or at a CRO.
• General toxicologyGLPStudy Directorexperience 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 listeningand leadershipskills
• 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

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.

More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

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

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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.