Associate Director, Clinical Supply Project Manager - Program - Hybrid

Merck; West Point (PA); On-site; USD 150,000 - 210,000; Full time

Job summary

Merck is seeking an Associate Director, Clinical Supply Project Manager - Program to lead end-to-end clinical supply planning. You will coordinate with clinical development, regulatory, quality, and supply chain to set timelines and strategies for multiple programs and ensure stable drug supply across studies.

You will manage budgets, escalate risks, and author critical supply documentation while mentoring team members and driving continuous improvement in planning processes.

Qualifications

• Bachelor's degree in scientific, business, or related field required; MS/MBA preferred.
• 8+ years in project management, clinical supply planning, scheduling, or related biopharma functions.
• Excellent communication and interpersonal skills for cross-functional stakeholders.
• Strong project management knowledge and clinical customer relationship management.
• Technical proficiency with SAP or Oracle and MS Office tools.

Responsibilities

• Lead GCS Planning program activities and timelines across assigned studies.
• Negotiate timelines and strategies with clinical development, regulatory, QA, and supply chain areas.
• Establish bulk manufacturing and release timelines for drug product.
• Maintain consolidated forecasts in SAP/Oracle for program products.
• Identify supply risks and escalate issues to GCS leadership as needed.
• Support program budgets and cost estimates; author supply documentation.

Skills

Project management

Clinical supply planning

Forecasting

Risk management

Cross-functional collaboration

Communication

Education

Bachelor's degree

MS/MBA preferred

Tools

SAP

Oracle

Excel

PowerPoint

Job description

Job Description

Associate Director, Clinical Supply Project Manager - Program

Global Clinical Supply - Planning

The Global Clinical Supply (GCS) organization is accountable for managing the 'end-to-end' integrated clinical supply chain across our Research & Development Division 's 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 Supply 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.
• Contribute to departmental strategy and participate in cross-functional projects as required by the therapeutic area leadership to drive continuous improvement & efficiency efforts.
• Focus on Customers & Patients.
• Make rapid, disciplined decisions.
• Demonstrates Ethics & Integrity.

Required Experience and Skills:

• Bachelor's degree in a scientific, business, or related discipline required, MS/MBA preferred.
• At least 8 years of experience in project management, clinical supply planning, scheduling, coordination and processing of supply chain activities, pharmaceutical development, clinical operations, or related biopharmaceutical functions.
• Excellent Communication & Interpersonal Skills: ability to effectively communicate with stakeholders at various levels, including cross-functional teams, senior management, external vendors, and clinical sites. Strong negotiation, influencing, and relationship-building skills to ensure alignment and collaboration in the supply planning process.
• Project Management Skills: strong knowledge of the principles of project management and clinical customer relationship management.
• Technical Proficiency: familiarity with supply chain systems and software (e.g. SAP or Oracle) and demand planning principles as well as Microsoft Excel, PowerPoint, and Word
• Strong Analytical & Problem-Solving Skills: ability to analyze complex data, identify trends, and make d