Associate Director, Clinical Supply Project Manager - Protocol (Hybrid)

$135,500 - $213,400/Yr

Merck & Co. - Rahway, NJ

Full-time - Mid Level

Onsite - Rahway, NJ

Chemical Manufacturing

About the position

The Global Clinical Supply (GCS) organization is responsible for managing the comprehensive clinical supply chain across the full portfolio of clinical trials within the company’s Research Laboratories. This includes the planning, sourcing, labeling, packaging, and delivery of clinical supplies to sites globally. The Protocol Clinical Supplies Project Manager (Protocol CSPM) acts as the primary point of contact for GCS at the protocol level, representing the GCS Planning organization to both internal and external customers. The Protocol CSPM is expected to work independently, designing strategic and operational plans for all clinical supply activities associated with assigned clinical studies. A solid understanding of drug development, clinical research, and the clinical supply chain is essential, along with strong interpersonal skills to negotiate with key stakeholders and drive results in a dynamic environment. The role involves close interaction with key partner organizations, such as clinical development, regulatory, quality, and other supply chain areas, to negotiate timelines and strategies for clinical supplies across assigned protocols. The Protocol CSPM is responsible for establishing timelines for clinical supply needs, providing signals for sourcing, labeling, packaging, and distribution of both development and marketed products. Additionally, the Protocol CSPM participates as a key stakeholder on Clinical Trial Teams (CTT), collaborates with functional area representatives, and authors the Clinical Supplies section of study protocols. They also prepare and present clinical supplies information at Investigator Meetings for assigned protocols. The Protocol CSPM works directly in the SAP system to create a visible forecast for study product needs and is responsible for authoring clinical supply documentation to support labeling, packaging, and critical CMC activities. Identifying significant supply risks and escalating clinical supply issues to GCS Leadership is also a key responsibility. The role includes supporting the collection of clinical supply chain metrics to assess business health and identify areas for operational improvement, as well as participating in Interactive Voice Response (IVR) System development and User Acceptance Testing (UAT) for assigned studies. The Protocol CSPM leads teams to solve complex problems, challenges current processes, and promotes teamwork and relationship building across diverse perspectives.

Responsibilities

• Serve as the primary protocol-level GCS point of contact for clinical development teams.
• Design strategic and operational plans for clinical supply activities associated with assigned studies.
• Negotiate timelines and strategies for clinical supplies with key partner organizations.
• Establish timelines for clinical supply needs per protocol and signal for sourcing, labeling, packaging, and distribution.
• Author the Clinical Supplies section of study protocols and present information at Investigator Meetings.
• Work in the SAP system to create a visible forecast for study product needs.
• Author clinical supply documentation to support labeling and packaging activities.
• Identify significant supply risks and escalate issues to GCS Leadership.
• Support the collection of clinical supply chain metrics for operational improvement.
• Participate in IVR System development and User Acceptance Testing for assigned studies.
• Lead teams to solve complex problems and promote teamwork.

Requirements

• Bachelor's degree in a scientific, business, or related discipline required; MS/MBA preferred.
• At least 8 years of experience in project management.
• At least 5 years of experience in planning, scheduling, coordination, and processing of clinical supply activities.
• Understanding of material requirements planning (MRP) systems and demand planning principles.
• Strong organizational, time management, and problem-solving skills.
• Results-oriented with proven ability to execute collaborative projects and develop subject matter expertise.
• Exceptional written and verbal communication skills with high personal integrity and credibility.
• Ability to prioritize tasks and initiatives to mitigate supply risks.
• Advanced proficiency in Microsoft Excel, PowerPoint, and Word.
• Experience with change management and leading process improvement initiatives.

Nice-to-haves

• Demonstrated ability to negotiate and resolve conflicts across functional areas.
• Strong knowledge of project management principles and clinical customer relationship management.
• Knowledge of drug development, production, distribution, and reconciliation processes.
• Experience leading teams and developing direct reports.
• Familiarity with data analytics/visualization software.
• Familiarity with SAP as an ERP/MRP system.
• Knowledge of Good Manufacturing Practices (GMP) requirements and quality procedures.

Benefits

• Bonus eligibility
• Long-term incentive if applicable
• Health care and other insurance benefits for employee and family
• Retirement benefits
• Paid holidays
• Vacation
• Sick days