Associate Principal Scientist, Toxicology/Study Director

About this role

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 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 complianc

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