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.

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 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 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 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

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

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. Please click here if you need an accommodation during the application or hiring process.

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.

Learn more about your rights, including under California, Colorado and other US State Acts

The salary range for this role is

$142,400.00 - $224,100.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of 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 about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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:

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

Hazardous Material(s):

N/A

Job Posting End Date:

*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

Learn more about this Employer on their Career Site

Associate Principal Scientist, Toxicology/Study Director