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

$135,500 - $213,400/Yr

Merck KGaA Darmstadt Germany - Rahway, NJ

Full-time - Mid Level

Onsite - Rahway, NJ

Chemical Manufacturing

About the position

The Program Clinical Supplies Project Manager (Program CSPM) plays a crucial role in the Global Clinical Supply (GCS) organization, managing the end-to-end clinical supply chain for clinical trials. This position serves as the primary point of contact for GCS Planning, representing the organization in interactions with internal and external stakeholders. The Program CSPM is responsible for designing strategic and operational plans for clinical supply activities, ensuring the timely delivery of clinical supplies while balancing the needs of patients and maintaining a stable supply of products.

Responsibilities

• Serve as the primary program-level GCS point of contact for clinical development teams and other stakeholders.
• Design strategic and operational plans for clinical supply activities associated with assigned programs.
• Establish timelines for bulk manufacturing needs and drug product release across assigned programs.
• Manage bulk drug supply and ensure proper allocation across studies within assigned programs.
• Identify significant supply risks and manage clinical supply issue escalations to GCS Leadership.
• Oversee the clinical supply budget and support protocol and program cost estimates.
• Author clinical supply documentation for labeling, packaging, and supply chain activities.
• Collect clinical supply chain metrics and participate in non-pipeline activities as a subject matter expert.
• Mentor new team members and support staff development.
• Drive continuous improvement initiatives to enhance clinical supply planning processes.

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 supply chain activities.
• Excellent communication and interpersonal skills to engage with stakeholders at various levels.
• Strong negotiation, influencing, and relationship-building skills.
• Knowledge of project management principles and clinical customer relationship management.
• Familiarity with supply chain systems and software (e.g., SAP or Oracle).
• Strong analytical and problem-solving skills to analyze complex data and optimize supply chain processes.
• Flexibility and adaptability to thrive in a fast-paced environment.
• Detail-oriented and organized with strong multitasking abilities.
• Continuous improvement mindset to identify process inefficiencies and develop solutions.

Nice-to-haves

• Proficiency in using supply chain management systems and software, including ERP systems (e.g., SAP).
• Familiarity with data analytics/visualization software.
• Knowledge of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP).

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