Sr. Manager, Clinical Supply Chain

2 weeks ago

Watertown, United States Alkermes Full time
Job Description

Position Summary:

The Sr. Manager/Manager position within Clinical Supply Chain leads end-to-end supply chain management on single to multiple clinical programs as part of a growing, dynamic Pharmaceutical Development organization. They work closely as a key point of contact with Clinical Operations, Regulatory Affairs, Quality, Internal & External Manufacturing, and other Clinical Supply Chain personnel leading supply activities for complex programs that may require multinational interactions. In addition, they coordinate and lead supply activities with both internal and external partners. The successful candidate will thrive in a highly collaborative team environment to ensure the successful development of new drugs.

Responsibilities

  • Review clinical trial protocols and understand impact on supply
  • Partner with Clinical Operations to identify demand assumptions and review enrollment plans and actuals for use in developing the supply requirements plans
  • Create, review, and update the clinical supply and demand plans based on strategic elements/study forecasts; apply simulation tools to drive optimal clinical supply plan as appropriate
  • Monitor enrollment activity and inventory levels to ensure demand requirements are met and ensure seamless coordination of demand and supply
  • Ensure changes in supply configuration, trial design, enrollment timeline, manufacturing availability and regulatory requirements are considered
  • Coordinate US and international distribution and logistics for clinical programs
  • Monitor inventory levels at depots and clinical sites through the life of a trial; take preventative actions to avoid potential supply issues
  • Manage drug returns process and site close-out activities and prepare drug reconciliation reports
  • Manage label development process
  • Participate in development, review and acceptance testing of IXRS
  • Develop IRT User Requirement Specifications and participate in User Acceptance Testing
  • Develop packaging and supply strategies to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans
  • Communicate with external partners on project requirements
  • Monitor, establish, and manage the creation of SOP's and work instructions that impact the department's day to day operations
  • Update relevant Trial Master Files (TMF) with supply related documents
  • Achieve operational objectives by contributing information and recommendations to strategic plans and budget reviews
  • Update job knowledge by participating in educational opportunities, reading professional publications, maintaining personal networks, and participating in professional organizations
  • Prepare program budgets and ensure financial Key Performance Indicators (KPIs) and relevant cost saving targets
  • Collaborate with cross-functional team on regulatory submissions, queries from Health Authorities and participate in Inspections
  • Select and apply simulation tools to drive optimal clinical supply plans as appropriate
Qualifications
  • Bachelor's degree in a related field and 10+ years' work experience, or a Masters in a Supply Chain or Business-related field and 7+ years' work experience. APICS certification (CPIM, CRIM, CSCP) is a plus.
  • Proven experience in clinical supplies environment with a strong understanding of clinical study design, execution, and impact of study drug supply from study start-up through trial completion
  • Familiarity with various clinical trial designs (randomized, double-blind, double-dummy, placebo-controlled, cross-over, etc.)
  • Demonstrated experience in inventory management (specifically IXRS systems) and forecasting global drug supply requirements
  • General knowledge of GMP and/or GCP, controlled substance management processes and DEA regulations
  • Excellent communication and influencing skills, strong collaboration skills and attention to details
  • Demonstrated ability to prioritize and manage activities independently in a complex external environment
  • Proficient knowledge of Microsoft Excel, PowerPoint, demand forecasting, and IRT system experience required. Knowledge of Smartsheet, SharePoint, Microsoft Project, and Planview preferred
  • Lean Six Sigma certification or training preferred
Physical Demands and Work Environment:
  • Travel domestic and international - up to 15%

Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work.

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About Us

Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for neurological disorders. Headquartered in Dublin, Ireland, Alkermes has a research and development center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.

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