Clinical Supplies Sr. Project Manager, Clinical Operations

Employer
Moderna
Location
Cambridge, MA
Salary
Competitive
Posted
September 25 2019
Ref
R1783
Discipline
Life Sciences, Biology
Organization Type
Biotech
The Role:

Moderna is seeking a Clinical Supplies Sr. Project Manager to manage the clinical supplies needs across its projects, as well as, work with packaging and labeling and IRT vendors and CROs. This position works collaboratively across several therapeutic area teams as well as cross functionally to support study needs. This successful candidate will be skilled at understanding the needs of critical programs with attention to detail, with a collaborative outlook, and with the ability to manage workload and meet project timelines.

Here's What You'll Do:
  • Responsible for logistics as required to support the labeling, packaging and shipment of clinical drug supplies to depots/investigative sites as well as other clinical supplies as necessary
  • Participate in business review meetings with third party drug supply vendors
  • Responsible for IRT requirements, user acceptance testing, and management
  • Responsible for Clinical Supplies Planning and Forecasting as required to meet program objectives
  • Develop and compile KPIs (metrics)
  • Primary liaison for inventory control and distribution activities including scheduling, issue resolution, change implementation, vendor oversight and scope review related to clinical supplies
  • Manages/Works with third party vendors, Functional Leads and interface with CMC for Production Planning & Distribution; develops forecast of all drug supply needs and works with CMC department to ensure goals are met
  • Generates and reviews processes as required and ensures compliance to relevant SOPs
  • Implements Industry Best Practices and templates for clinical drug supply activities
  • Works with CMC and clinical group on Master Production Schedule 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
  • Monitors and tracks shipments to ensure smooth transit through the logistical path -including international shipping
  • Responsible for coordinating and scheduling drug labeling and packaging activities in conjunction with CMC, clinical, regulatory departments
  • Oversee vendor activities including procurement, labeling performance, on-time delivery, quality, improvement initiatives and issue resolution
  • Develop pharmacy manual in conjunction with relevant cross functional leads
  • Develop drug supply training materials for investigational sites


Here's What You'll Bring to the Table:
  • At least five - eight years of clinical drug supply management/clinical supply chain/clinical supplies experience in a clinical research environment is preferred
  • Bachelor's degree in a science-based subject
  • Prior Cold Chain packaging, labeling, distribution experience required
  • IRT design and management experience required.
  • Clinical Supplies Planning and Forecasting experience required
  • Experience with Clinical Supply Inventory Management systems required
  • Prior Biopharmaceutical, pharmaceutical or chemical manufacturing experience preferred
  • Creative, capable problem-solver
  • Experience in establishing and maintaining relationships with vendors and attending business review meetings (Vendor oversight)
  • 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 candidate 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
  • 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)


Why join Moderna

At Moderna, we believe messenger RNA, or mRNA, is the "software of life." Every cell in the body uses mRNA to provide real-time instructions to make the proteins necessary to drive all aspects of biology, including in human health and disease. Given its essential role, we believe mRNA could be used to create a new category of medicines with significant potential to improve the lives of patients.

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 ranked in the top ten of Science's list of top biopharma industry employers for the past four years. 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-KF1

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.

Similar jobs

Similar jobs