Manager, Clinical Supply Chain

2 weeks ago

Waltham, United States Alkermes, Inc. Full time

Position Summary:
The 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
  • Assist in the creation of SOP's and work instructions
  • 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

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 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
  • Travel domestic and international - up to 15%

#LI-MB1

About Us

Why join Team Alkermes?

Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes 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 various neurological disorders, including narcolepsy.

Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023).


Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee 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 characteristic protected by local, 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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