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Manager/Senior Manager, Clinical Supply Chain

Company

BeiGene

Address , Remote
Employment type FULL_TIME
Salary $126,700 - $171,700 a year
Expires 2023-06-09
Posted at 1 year ago
Job Description
BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
General Description:
  • 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.
  • Develops direct and indirect reports to enhance the business across all areas
  • Has a passion for continuous improvement and works with management to develop and implement process improvements to build the organization for the future.
  • Defines and leads the development of program and/or clinical trial supply within Global Supply Chain with responsibility for line management, strategic and/or tactical planning and alignment with broader organizational goals
  • 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.
  • Represents Clinical Supply Chain to internal stakeholders and manages relationships with external supply partners.
  • Manages or oversees drug supply activities related to planning, label development, label & pack, and distribution for one or more clinical programs and/or studies.
  • Actively develops and oversees supply plans to ensure accurate and continuous supply to patients while reducing risk and minimizing waste.
Essential Functions of the job:
  • Additional responsibilities as required.
  • Manage GMP inventory throughout the supply chain, develop inventory reports, manage upcoming expiry, and ensure drug accountability.
  • Support IRT user acceptance testing, develop IRT supply strategy (DNX parameters), and oversee ongoing supply activities in system.
  • Represent the Clinical Supply Chain on cross functional project meetings such as; Clinical Demand and Operations Planning (CD&OP), Development Core Teams (DCT) and Clinical Study Teams (CST) and provide a high service level to internal stakeholders (e.g. Clinical Operations, Regulatory, Quality, CMC).
  • Ensure label text and proofs are in accordance with applicable rules, regulations, product specifications, and clinical study protocol(s).
  • Assist in the creation and/or revising of process documents such as Standard Operating Procedures.
  • Monitor schedule adherence of production schedules and make course corrections if needed.
  • Develop supply strategies to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans
  • Responsible for investigation of exceptions to determine root causes, implement CAPAs and drive closure.
  • Coordinate and track bulk shipments to CMOs, depots, and vendors. Maintain and track import licenses.
  • Work with Clinical Operations to understand clinical demand requirements and ensure alignment with study teams to supply plans and timelines.
  • Lead cross functional projects and process improvements related to drug supply.
  • Coordinate review and approval of labels with stakeholders (e.g. Regulatory, Clinical Operations, CRO) and CMOs.
  • Create supply and inventory plans and develop production schedules for clinical trial materials.
  • Manage the relationship and oversee daily activities for finished goods FG label & pack CMOs and distribution vendors.
Supervisory Responsibilities:
  • Mentors, and/or oversees staff so that they are getting opportunities / access to different aspects of clinical supply chain and broadening /getting appropriate developmental experiences for where they are in their careers
Competencies:
Technical Experience:
  • Experience in deviation investigation and CAPA implementation.
  • Strong collaboration and excellent team skills to be successful in cross-functional and multi-cultural teams.
  • Experience in vendor oversight and managing external partnerships and relations.
  • Knowledge of IRT system setup and functionality and proficiency with Excel modeling.
  • Demonstrates knowledge of global clinical trials and the drug development process.
  • Understands comprehensive global pharmaceutical regulatory requirements (e.g. cGMP, GDP, and GCP).
  • Strong analytical, problem solving, and communication skills.
Education Required:
BS or Master’s Degree preferred in scientific or healthcare discipline, or supply chain, operations management or similar.
+8 years progressive experience in Supply Chain preferably within the biotech, pharmaceutical, CRO, industry.
Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.
Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.
Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.
Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.
Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
Project Management - Communicates changes and progress; Completes projects on time and budget.
Computer Skills: Proficient in Microsoft Office applications (Word, Excel, and Outlook). IRT experience desired. SAP experience and/or supply/demand software experience a plus.

Other Qualifications: Due to global nature of company early morning or evening meeting availability may be required
Travel: up to 10%
Salary Range: $126,700.00 - $171,700.00 annually
BeiGene 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. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeiGene Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.