Associate Director, Clinical Supply Chain
About the Role
Defines and leads the development of program and/or clinical trial supply within Global Supply Chain, with responsibility for strategic and/or tactical planning and alignment with broader organizational goals. Applies deep knowledge of clinical supply chain areas to provide expert input and guidance on supply capability and feasibility to enable timely and effective execution of clinical trials.
Actively develops and oversees supply plans to ensure accurate and continuous supply to patients while reducing risk and minimizing waste. Manages or oversees drug supply activities related to planning, label development, label & pack, and distribution for one or more clinical programs and/or studies. Represents Clinical Supply Chain to internal stakeholders and manages relationships with external supply partners.
Applies a working knowledge of clinical supply best practices, IRT systems, as well as experience working within a GxP environment to deliver on time and in full high quality clinical IMPs. Has a passion for continuous improvement and works with management to develop and implement process improvements to build the organization for the future.
Responsibilities
- Represent the Clinical Supply Chain on cross functional project meetings such as Clinical Demand and Operations Planning (CD&OP) and Development Core Teams (DCT).
- Represent on Clinical Study Teams (CST) and program development teams and provide a high service level to internal stakeholders (e.g. Clinical Operations, Regulatory, Quality, CMC).
- Provide managerial support to employees with the overall responsibility of leading, training, and mentoring for effective performance.
- Work with Clinical Operations to understand clinical demand requirements and ensure alignment with study teams to supply plans and timelines.
- Develop strategies for inventory plans and ensure production schedules for clinical trial materials are on track.
- Monitor and oversee schedule adherence of production schedules and make course corrections if needed.
- Oversee GMP inventory throughout the supply chain, develop inventory reports, manage upcoming expiry, and ensure drug accountability.
- Oversee daily activities for finished goods (FG) label & pack CMOs and distribution vendors with internal stakeholders.
- Responsible for investigation of exceptions to determine root causes, implement CAPAs and drive closure.
- Ensure label text and proofs are in accordance with applicable rules, regulations, product specifications, and clinical study protocol(s).
- Develop IRT supply strategy and oversee ongoing supply activities in system and inputs for system builds.
- Develop supply strategies to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans.
- Prepare and manage the Clinical Supply Chain functional budget for studies/programs.
- Lead cross functional projects and process improvements related to drug supply.
- Create and/or revise process documents such as Standard Operating Procedures.
- Additional responsibilities as required.
Requirements
- Bachelor or Master Degree in Business Administration, Operations Management, or similar education required.
- 8+ years of progressive experience in Supply Chain preferably within the biotech, pharmaceutical, or CRO industry.
- People leadership and development experience preferred.
Skills
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
Pay
Salary Range: $138,500.00 - $188,500.00 annually.
BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor.
Benefits
- Annual bonus plan (Non-Commercial roles) or incentive compensation plan (Commercial roles).
- Discretionary equity awards and voluntary participation in the Employee Stock Purchase Plan.
- Comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.