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BeOne

Associate Director, Clinical Supply Chain

RemoteUnited States only
Published
Role
Operations
Experience
Lead
$138.5k–$188.5k/yr
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Open to US only. Set where you work from to check your eligibility.

No BS summary

Clinical supply chain leader with 8+ years of progressive supply chain experience, preferably in biotech, pharma, or CRO. Must have clinical trial supply expertise, GxP experience, IRT systems knowledge, and people leadership experience is preferred. US remote role.

Core skills

IRT systemsGxPGMP

What you'll do

  • 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
  • Apply 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.
  • Works with management to develop and implement process improvements to build the organization for the future.
  • Represent the Clinical Supply Chain on cross functional project meetings such as Clinical Demand and Operations Planning (CD&OP), Development Core Teams (DCT).
  • Represent on Clinical Study Teams (CST) and program development teams and provide a high service level to internal stakeholders such as Clinical Operations, Regulatory, Quality, and 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.
  • Develops strategies for inventory plans and ensures 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).
  • Develops 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.
  • Manage and mentors direct reports. Direct reports may reside at locations other than your base location.

What they require

  • Scientific and business professionals who are highly motivated, collaborative, and share a passionate interest in fighting cancer.
  • 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, CRO, industry.
  • Preferred: People leadership and development experience.
  • 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

Benefits

  • Non-Commercial roles are eligible to participate in the annual bonus plan.
  • Commercial roles are eligible to participate in an incentive compensation plan.
  • All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards.
  • Employees may voluntarily participate in the Employee Stock Purchase Plan.
  • Medical
  • Dental
  • Vision
  • 401(k)
  • FSA/HSA
  • Life Insurance
  • Paid Time Off
  • Wellness

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals focused on fighting cancer.

BiotechEnterprisebeone.es/

What people say about this company

3.0/ 5

$138.5k–$188.5k/yr