Associate Director, Project Management

Job Description

The Associate Director in the Nonclinical Drug Safety (NDS) Program Coordination and Planning group supports the technical, operational, and scientific aspects of drug development in NDS. This role partners with Discovery Program Leaders (Discovery Team Reps), Compound Leaders (Early Development and Product Development Team Reps), and Therapeutic Area Leaders. Working cross-functionally in a highly matrixed organization, the Associate Director ensures efficient coordination of nonclinical safety data to support discovery and development programs within the Research & Development Division.

Primary Responsibilities

• Ensure scientifically rigorous study designs are developed, requested, and communicated within NDS and associated study scheduling systems.
• Interface with Operations–Project Planning (NDS) and impacted laboratory/operational areas on changes in study designs or timelines.
• Coordinate collaboration and interactions with Central Pharmacy (NDS) and other areas in Discovery, Preclinical, and Translational Medicine (DPTM) for drug supply, allocation of materials, formulation, and stability matters.
• Coordinate with NDS and program team stakeholders to manage and align study and submission timelines, ensuring that NDS deliverables are completed in accordance with program objectives.
• Assist with the development of regulatory packages, including but not limited to PSURs/DSURs, IBs, IND/IMPDs, and WMAs.
• Track regulatory agency comments and resolutions.
• Highlight program issues and ensure they are appropriately escalated to NDS management.
• Standardize and streamline drug development procedures within NDS and across DPTM.
• Train and support new Discovery Program Leaders (DPLs) and Compound Leaders (CLs) in components of drug discovery and development.
• Lead independent projects/assignments related to nonclinical drug discovery and development.
• Integrate AI/ML tools, including generative AI, to streamline program support activities, synthesize nonclinical data, mine insights, generate hypotheses, and inform project decisions.

Minimum Education

• BA/BS or equivalent in biological sciences, chemical or pharmaceutical/medical/regulatory sciences required.
• Preferred: MA/MS/MBA in related science or business discipline, or a project management certification (e.g., Project Management Professional [PMP]).

Required Experience and Skills

• At least 5 years of experience in NDS or similar functions.
• Proven knowledge of drug discovery and development processes and guidelines, particularly nonclinical strategies.
• Familiarity with the range of nonclinical studies required to support drug discovery, clinical development, and marketing approval.
• Demonstrated cross-functional collaboration skills and the ability to succeed in a matrixed environment.
• Excellent communication skills, including experience facilitating meetings, presenting, and managing team interactions.
• Ability to execute independent projects and balance activities for multiple projects simultaneously.
• Ability to take on urgent assignments independently, reprioritize other work, and coordinate with other areas as needed.

Required Skills:

Preferred Skills:

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Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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.

Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information:

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

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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. 

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