Job Description

As an Associate Director in the Nonclinical Drug Safety (NDS) Program Coordination and Planning group, the incumbent will be responsible for partnering with Discovery Program Leaders (Discovery Team Reps), Compound Leaders (Early Development and Product Development Team Reps), and Therapeutic Area Leaders to support the technical, operational, and scientific aspects of drug development in NDS. The successful candidate will work cross-functionally in a highly matrixed organization to ensure successful and efficient coordination of nonclinical safety data in support of discovery and development programs in our Research & Development Division.

Primary responsibilities include:

• Ensuring scientifically rigorous study designs are developed, requested, and communicated within NDS and associated study scheduling systems.

• Interfacing 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.

• Collaborate with key stakeholders to determine drug requirements and availability for NDS studies.

• Request, track, and assist with the development of regulatory packages including but not limited to PSURs/DSURs, IBs, IND/IMPDs, and WMAs.

• Tracking regulatory agency comments and resolutions.

• Partnering with program teams and NDS stakeholders to provide monthly tracking in a pipeline management tool for the status, issues, and resolution plans on all active programs.

• Highlighting and ensuring that program issues are appropriately escalated to NDS management.

• Standardizing and optimizing procedures and processes involved in compound development within NDS and across DPTM.

• Training new Discovery Program Leaders (DPLs) and Compound Leaders (CLs) in particular components of drug discovery and development.

• Leading independent projects/assignments related to nonclinical drug discovery and development.

Education Minimum Requirement:

• BA/BS or equivalent in biological sciences, chemical or pharmaceutical/medical/regulatory sciences required.

Preferred:

• MA/MS/MBA in the above sciences,business, or project managementaccreditation.

Required Experience and Skills:

• At least 5 years of experience in NDS or similar function.

• Proven understanding of drug discovery and development processes, particularly as it relates to nonclinical aspects of discovery and development as well as familiarity with the broad scope of required nonclinical studies that support drug discovery, clinical development, and marketing approval.

• Strong evidence of strong cross-functional collaborative skills and ability to thrive in a matrixed work environment.

• Excellent communication skills, including experience with meeting facilitation and presentations.

• Ability to execute independent projects, and balance activities for multiple projects simultaneously.

• Capacity and flexibility to immediately and independently take on new urgent assignments, balance other work accordingly, and interface with other areas as needed to accomplish the assignment.

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

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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Requisition ID:R340914