Associate Director, Clinical Supplies Project Manager - Program (Hybrid)

Program Clinical Supplies Project Manager

The Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across our company Research Laboratories portfolio of clinical trials. GCS is accountable for the planning, sourcing, labeling, packaging and delivery of clinical supplies to clinical sites globally. The GCS Planning (Planning) organization is the key interface between clinical development teams and the operational / executional arms within the business.

The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of contact representing the GCS Planning organization to customers both internal and external to GCS and serves as the lead GCS spokesperson at clinical and development related meetings. Working independently, the Program CSPM designs strategic and operational plans for all clinical supply activities associated with the clinical studies in their assigned compound(s) / program(s). The incumbent must have demonstrated understanding of E2E product development process & connectivity between functions supporting pipeline (i.e. clinical development, CMC, supply chain, & human health), and balancing needs of patients & ensuring stable supply of product.

Primary activities include, but are not limited to :

• Interacts closely with key partner organizations (as a lead GCS Planning program representative) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines, strategies and other related topics for all clinical supplies across all assigned program(s).
• Responsible and accountable for establishing the timelines for bulk manufacturing needs and release of drug product across assigned program(s).
• Works directly in the SAP system to establish a consolidated, visible forecast for all products used within the assigned program(s) (i.e. Bulk Drug Product).
• Oversees all bulk drug supply management and ensures proper allocation of drug product as needed across studies within assigned program(s).
• Responsible for identifying significant supply risks associated with clinical bulk activities in addition to serving in a lead role for clinical supply issue escalation within their program(s) (and subsequent manage thereof) to GCS Leadership.
• Responsible for the clinical supply budget for respective program(s) and for supporting all protocol and program cost estimates requested by Product Development Teams.
• Responsible for authoring clinical supply documentation in support of labeling and packaging activities as well as supply chain documentation to support critical CMC activities.
• Support the collection of clinical supply chain metrics and / or participate in critical non-pipeline activities as a subject matter expert in a particular area of expertise.
• Mentors new team members and supports staff development, as needed demonstrates high capability to solve unstructured problems, make informed risk decisions considering both technical & business risks, & influence portfolio decisions with facts and data. Demonstrates ability to balance strategy with ability for tactical execution and has strong ownership & accountability of assigned work.
• Drive continuous improvement initiatives to enhance the efficiency, accuracy, and effectiveness of clinical supply planning processes and systems.
• Stay updated on industry trends, regulations, and best practices related to clinical supply planning and incorporate them into the team's operations.
• Focus on Customers & Patients.
• Make rapid, disciplined decisions.
• Demonstrates Ethics & Integrity.

Required Experience and Skills :

Preferred Experience and Skills :

Required Skills :

Adaptability, Change Management, Clinical Research, Cross-Functional Team Leadership, Data Analysis, Drug Development, Logistics, Multiple Therapeutic Areas, Process Optimization, Publications Management, Regulatory Compliance, Risk Management, Sourcing and Procurement, Strategic Planning, Strategic Thinking, Supply Chain Optimization, Supply Management, Terminology Management

Preferred Skills :

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'.

The salary range for this role is $139,600.00 - $219,700.00. 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.

Employee Status : Regular

Relocation : No

VISA Sponsorship : No

Travel Requirements : 10%

Flexible Work Arrangements : Hybrid

Shift : 1st - Day

Valid Driving License : No

Hazardous Material(s) : n / a

Job Posting End Date : 11 / 12 / 2025