Associate Director, Non -Clinical Outsourcing

Job Description

Who We Are

Nonclinical Drug Safety (NDS) empowers groundbreaking discovery research through advanced in-silico, in-vitro, and in-vivo models that influence the selection, development, and marketing of safe therapeutics. We maximize the safety attributes of drug candidates and inform our clinical partners through insightful non-clinical safety assessments. Our approach, rooted in regulatory toxicology, novel models, unique de-risking strategies, and innovative problem-solving, is designed to support informed decision-making and ultimately deliver the most accurate product labels.

Position Overview

NDS is seeking an Associate Director of Nonclinical Outsourcing to lead the sourcing of nonclinical studies and associated activities by collaborating with internal colleagues and our contract research organizations (CROs) to provide initial study designs, obtain project estimates, assist with the development of study protocols, assist Study Monitors with the logistical components of all nonclinical studies, and ensure alignment with internal development team timelines. The role supports programs from early discovery through development across therapeutic modalities, enabling nonclinical data that informs key decisions and regulatory submissions.

Key Responsibilities

• Lead the sourcing of nonclinical safety studies (GLP and non-GLP) for inclusion in regulatory submissions that support clinical development and/or marketing authorization.

• Interact directly with external client service representatives, management and other key personnel (e.g., Study Directors) at multiple CROs for study coordination, planning of initial protocol development, coordinating study report review, and defining project study timelines.

• Partner with Study Monitors and internal functional group experts to facilitate the planning, development, tracking, and reporting timelines of nonclinical outsourced studies

• Participate in selection of CROs, including qualification/scientific assessments and the tracking of vendor performance.

• Monitor CRO performance and drive consistency in processes, quality, and communication

• Partner with internal stakeholders, our Research & Manufacturing division, Finance, and NDS leadership to develop, track, and forecast our sourcing budget, ensuring alignment with NDS priorities, accurate financial planning, and proactive identification of risks and variances.

• Oversee operational readiness for study initiation, including contracts, materials, and documentation.

• Maintain timely, accurate tracking of studies and provide clear status updates to internal stakeholders on externally outsourced work.

• Identify and implement process improvements to enhance sourcing efficiency and quality.

Qualifications

Education:

• Bachelor’s degree in biology, toxicology, animal sciences, pharmacology, pharmaceutical sciences, chemistry, biochemistry, biomedical sciences, or related field with 8+ years of relevant experience in the biotechnology/pharmaceutical industry or contract research organization.

Required Skills:

• Knowledge of global regulatory guidelines (e.g., ICH, GLP, SEND).

• Strong attention to detail, with the ability to critically evaluate study-related documentation and correspondence.

• Outstanding communicator responsible for conveying key messages to internal stakeholders and external vendors.

• Knowledge of nonclinical safety study designs.

• Demonstrated organizational and multi-tasking skills and effective time/program management.

• Ability to navigate and be successful in a fast-paced, highly-matrixed and program team-driven environment with frequent course corrections and changing deliverables and timelines.

Preferred Skills:

• Advanced degree (MS, PhD, or equivalent)

• Direct experience working with CROs, including vendor selection and performance management.

• Previous experience conducting nonclinical safety studies.

• Experience with budgeting, contracting, or financial tracking.

Required Skills:

Adaptability, Budget Development, Decision Making, Drug Development, Innovative Solutions, Knowledge Management, Non Clinical Research, Project Management Tools, Project Planning, Regulatory Compliance, Risk Management, Root Cause Analysis (RCA), Schedule Management, Strategic Planning

Preferred Skills:

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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:

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The salary range for this role is

$129,000.00 - $203,100.00

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:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

06/29/2026

*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.