Senior Specialist, Clinical Supply Project Manager - Protocol – Hybrid

Protocol Clinical Supplies Project Manager

Job Description

• Participates as a key stakeholder on the Clinical Trial Teams (CTT) and collaborates closely with other functional area representatives to negotiate timelines and strategy for clinical supplies.
• Interacts with key partner organizations such as clinical development, regulatory, quality and other supply chain areas to address clinical supply and/or change management related topics.
• Responsible and accountable for establishing the timelines for clinical supply needs per study and providing the signal for sourcing, manufacturing, packaging, and distribution for our Company's development products and our Company's non‑marketed products.
• Analyzes and anticipates clinical study risks as they relate to clinical supply chain deliverables and prepares, analyzes, and/or develops mitigation strategies for review with clinical partners and senior leaders.
• Utilizes key tools/systems such as IRT, Microsoft Power Apps, SWMS, Veeva, MEDS, My Learning, and other Microsoft Applications to manage clinical supplies for assigned studies.
• Works directly in the SAP system to establish a consolidated, visible forecast for all study product needs (Bulk Drug Product and Clinical Finished Goods).
• Authors clinical supply documentation in support of labeling and packaging activities and of the Clinical Supplies section of the study protocol, and presents this information at Investigator Meetings.
• Collects clinical supply chain metrics and participates in critical non‑pipeline activities.
• Participates in IVR system development and User Acceptance Testing for assigned studies.
• Initiates and processes change controls in collaboration with GCS Planning and other stakeholders, following SOPs/BPs and QMS procedures.
• Participates in deviation record processing and supports deviation investigations as required.
• Supports regulatory agency inspections for assigned trials as required.
• Demonstrates capability to solve unstructured problems, make informed risk decisions, influence portfolio decisions, and balance strategy with tactical execution.

• Bachelor’s Degree in a scientific, business or related discipline.
• At least 5 years of experience in project management.
• At least 5 years of experience in planning, scheduling, coordination, or processing of supply chain activities.
• Excellent communication and interpersonal skills, including cross‑functional collaboration.
• Strong negotiation, influencing and relationship‑building skills.
• Project management knowledge and familiarity with clinical customer relationship management.
• Technical proficiency with supply chain systems (SAP or Oracle) and demand planning principles, including Microsoft Excel, PowerPoint and Word.
• Strong analytical and problem‑solving skills, ability to analyze complex data and make data‑driven decisions.
• Flexibility and adaptability to a fast‑paced dynamic environment.
• Detail‑oriented and organized, capable of multitasking and meeting tight deadlines.
• Continuous improvement mindset and experience with process improvement initiatives within clinical supply planning.
• Knowledge of GMP and GCP highly desirable.

• Results orientation with execution of collaborative projects and subject‑matter expertise.
• Knowledge of order management, supply chain operations and document control.
• Experience with ERP systems (e.g., SAP) and inventory management systems.
• Proven record in project/portfolio management.
• Experience with KPI management and MRP.

• Salary range: $ - $.
• Eligibility for annual bonus and long‑term incentive, if applicable.
• Comprehensive benefits package including medical, dental, vision and other insurance for employees and families.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, compassionate and sick days.

We are an equal employment opportunity employer. We provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status or other applicable legally protected characteristics. We comply with affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit the EEOC.