Associate Director, Clinical Supply Project Manager - Program - Hybrid
The Global Clinical Supply (GCS) organization manages the end-to-end integrated clinical supply chain across the Research & Development Division's portfolio of clinical trials, accountable for planning, sourcing, labeling, packaging, and delivery of clinical supplies to sites globally. The GCS Planning organization serves as the key interface between clinical development teams and operational/executional arms. The Program Clinical Supply Project Manager (Program CSPM) acts as the primary program-level GCS point of contact, representing GCS Planning to internal and external customers and serving as lead GCS spokesperson at clinical and development meetings. Working independently, the Program CSPM designs strategic and operational plans for all clinical supply activities across assigned compound(s)/program(s), requiring demonstrated understanding of the end-to-end product development process and connectivity between functions (clinical development, CMC, supply chain, human health) while balancing patient needs and stable product supply.
Responsibilities
- Interact closely with key partner organizations (clinical development, regulatory, quality, other supply chain areas) as lead GCS Planning program representative to negotiate timelines, strategies, and related topics for all clinical supplies across assigned program(s).
- Establish and own timelines for bulk manufacturing needs and release of drug product across assigned program(s).
- Work directly in SAP to establish a consolidated, visible forecast for all products used within assigned program(s) (e.g., Bulk Drug Product).
- Oversee all bulk drug supply management and ensure proper allocation of drug product across studies within assigned program(s).
- Identify significant supply risks associated with clinical bulk activities; serve in a lead role for clinical supply issue escalation within program(s) and manage escalation to GCS Leadership.
- Manage the clinical supply budget for respective program(s) and support all protocol and program cost estimates requested by Product Development Teams.
- Author clinical supply documentation supporting labeling and packaging activities, and supply chain documentation supporting critical CMC activities.
- Support collection of clinical supply chain metrics and/or participate in critical non-pipeline activities as a subject matter expert.
- Mentor new team members and support staff development as needed.
- Demonstrate high capability to solve unstructured problems, make informed risk decisions considering technical and business risks, and influence portfolio decisions with facts and data.
- Balance strategy with tactical execution; show strong ownership and accountability of assigned work.
- Drive continuous improvement initiatives to enhance 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 team operations.
- Contribute to departmental strategy and participate in cross-functional projects as required by therapeutic area leadership to drive continuous improvement and efficiency.
- Focus on customers and patients; make rapid, disciplined decisions; demonstrate ethics and integrity.
Requirements
- 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 and 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 project management principles and clinical customer relationship management.
- Technical proficiency: familiarity with supply chain systems and software (e.g., SAP or Oracle) and demand planning principles, plus Microsoft Excel, PowerPoint, and Word.
- Strong analytical and problem-solving skills: ability to analyze complex data, identify trends, and make data-driven decisions to optimize supply chain processes.
- Flexibility and adaptability: ability to thrive in a fast-paced, dynamic environment and adapt quickly to changing business needs and priorities.
- Detail-oriented and organized: strong attention to detail in managing complex supply chain activities; ability to multitask, prioritize, and meet tight deadlines.
- Continuous improvement mindset: proactive approach to identify process inefficiencies, develop solutions, and drive continuous improvement within clinical supply planning.
- Proven record in project/portfolio management.
- Knowledge of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) highly desirable.
Preferred Qualifications
- Proficiency in supply chain management systems and software, including ERP systems (e.g., SAP), demand planning tools, and inventory management systems.
- Familiarity with data analytics/visualization software.
- Familiarity with GMP requirements, quality procedures, and Standard Operating Procedure (SOP) execution.
Skills
- Required: Clinical Development, Data Analysis, Project Management, Strategic Thinking
- Preferred: (see Preferred Qualifications above)
Compensation
The salary range for the primary location (USA - Pennsylvania - West Point) is $142,400.00 - $224,100.00. This range reflects the company's reasonable expectation of base salary at time of posting; actual placement depends on education, qualifications, certifications, experience, skills, geographic location, government requirements, and business needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. Different compensation guidelines may apply for additional locations; if a salary range is not listed for your location, the Talent Acquisition team will provide further information.
Benefits
Comprehensive benefits package including medical, dental, and vision healthcare and other insurance benefits (for employee and family), retirement benefits including 401(k), paid holidays, vacation, and compassionate and sick days. More details available at https://jobs.merck.com/us/en/compensation-and-benefits.
Work Arrangement
Hybrid flexible work arrangement; 1st shift (Day); travel requirements approximately 10%. No relocation offered. No visa sponsorship. Valid driving license not required. No hazardous material handling.
Location
Primary location: USA - Pennsylvania - West Point. Additional locations may be considered; compensation for other locations varies.