Associate Director, Project Management, Nonclinical Drug Safety Program Coordination

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 management accreditation.

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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