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Clinical Supplies Planning Lead, Associate Director

Employer
Moderna
Location
Cambridge, MA
Salary
Competitive
Closing date
Mar 12, 2020

View more

Discipline
Life Sciences, Biology
Job Type
Research Scientist
Organization Type
Biotech

Job Details

The Role:
Moderna is seeking a Clinical Supplies Planning Lead to manage the clinical drug supply planning and forecasting needs across its clinical projects, as well as, work with clinical packaging organizations, IRT vendors, and CROs. This position will work collaboratively with therapeutic area and cross-functional teams to gather applicable information and utilize relevant systems to create study supply plans, forecast study drug supply, and provide delivery timelines and budgets. This position will drive process and best practice for clinical supplies planning and forecasting. The successful candidate will be skilled at understanding the needs of our therapeutic area teams, have excellent attention to detail, interact collaboratively, and manage workload to meet project timelines. This position may have direct reports.

Here's What You'll Do:
  • Drive best practice for clinical supplies planning and forecasting
  • Develops timelines to support clinical drug supply packaging and distribution
  • Responsible for generation of forecast reporting
  • Responsible for development of clinical drug supply strategy
  • Oversee the distribution process and inventory control to minimize risks to clinical drug supply
  • Identify and communicate clinical drug supply risks and opportunities to stakeholders
  • Responsible for clinical supply comparator and ancillary strategy
  • Participates in business review meetings with third party drug supply vendors
  • Provides input into IRT design, functionality and management
  • Responsible for clinical supplies planning and forecasting as required to meet program objectives
  • Assist in the development and compilation of KPIs (metrics) to monitor performance
  • Primary interface with Supply Chain/CMC for clinical drug supply production planning
  • Generates, reviews, and implements processes as required and ensures compliance to relevant SOPs
  • Implements industry best practices for clinical drug supply planning and forecasting activities
  • Collaborates with Supply Chain/CMC on production schedules so timing of clinical trial drug needs are met
  • Maintains collaborative relationships with third party vendors to assure the complete scope of planning activities remains connected with operations and compliant with quality requirements


Here's What You'll Bring to the Table:
  • At least 8 years of clinical supply management experience in a clinical research environment and 5 additional years overall clinical operations experience
  • Bachelor's degree in a science-based subject (advanced degree preferred)
  • Prior Cold Chain packaging, labeling, distribution experience required.
  • IRT implementation and management experience
  • Prior Biopharmaceutical, pharmaceutical or chemical manufacturing experience preferred
  • Creative, capable problem-solver
  • Experience in establishing and maintaining relationships with vendors
  • Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines and demonstrated understanding of clinical research protocol requirements
  • Demonstrated proficiency with word processing, spreadsheet, database, presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint)
  • Successful c andidate will be curious in exploring new path for clinical research, bold in proposing creative solutions and ideas. Will work collaboratively with multifunctional teams and partners and will be relentless in pursuing successful outcomes


Here's What We'll Bring to the Table:
  • Daily on-site catered lunches
  • Company-provided iPhone
  • Free parking, monthly subway pass or a subsidized commuter rail pass
  • Free annual corporate membership to Bluebikes
  • Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
  • Flexible Spending Accounts for medical expenses and dependent care expenses
  • 16 weeks of 100% paid parental leave for all new parents
  • 16 weeks 100% paid family caregiver leave
  • 20 weeks 100% paid medical leave
  • Eligible for "Moderna Month" (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)
  • Adoption assistance and discounts to local childcare centers, as well as access to care.com
  • 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
  • A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
  • Voluntary legal assistance plan
  • 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)


About Moderna:

Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body's cells to produce intracellular, membrane or secreted proteins that have a therapeutic or preventive benefit with the potential to address a broad spectrum of diseases. Moderna's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been named a top employer by Science for the fifth year in a row. To learn more, visit www.modernatx.com .

Our Mission:
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.

#LI-MM1

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Company

Moderna is a clinical stage pioneer of messenger RNA (mRNA) Therapeutics™, an entirely new in vivo drug technology that directs the body’s cells to produces human proteins, antibodies and novel protein constructs, which are in turn secreted or active intracellularly. Founded in 2011, we are headquartered in Cambridge, Mass. 

Our Team and Mission

We currently have over 500 team members, an exceptional group of scientists and industry professionals who are wholly committed to advancing Moderna’s mission:  deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.

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