Manager, Project Management, Clinical Supplies

The Role:

Moderna is seeking a Clinical Supplies 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 IRT requirements, user acceptance testing, and management
• Responsible for Clinical Supplies Planning and Forecasting as required to meet program objectives
• 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
• Participate in business review meetings with third party drug supply vendors
• Oversee vendor activities including procurement, labeling performance, on-time delivery, quality, improvement initiatives and issue resolution
• Develop drug supply training materials for investigational sites
• Monitors and tracks shipments to ensure smooth transit through the logistical path –including international shipping
• Develop and compile KPIs (metrics)
• 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
• Develop pharmacy manual in conjunction with relevant cross functional leads
• Primary liaison for inventory control and distribution activities including scheduling, issue resolution, change implementation, vendor oversight and scope review related to clinical supplies
• Maintains collaborative relationships with third party vendors to assure the complete scope of planning activities remains connected with operations and compliant with quality requirements
• Works with CMC and clinical group on Master Production Schedule so timing of clinical trial drug needs are met
• Responsible for coordinating and scheduling drug labeling and packaging activities in conjunction with CMC, clinical, regulatory departments
• Implements Industry Best Practices and templates for clinical drug supply activities

Here’s What You’ll Bring to the Table:

• Creative, capable problem-solver
• Experience in establishing and maintaining relationships with vendors and attending business review meetings (Vendor oversight)
• Prior Biopharmaceutical, pharmaceutical or chemical manufacturing experience preferred
• Clinical Supplies Planning and Forecasting experience required
• IRT design and management experience required.
• Bachelor’s degree in a science-based subject
• Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines and demonstrated understanding of clinical research protocol requirements
• At least 3-5 years of clinical drug supply management/clinical supply chain/clinical supplies experience in a clinical research environment is preferred
• Prior Cold Chain packaging, labeling, distribution experience required
• Demonstrated proficiency with word processing, spreadsheet, database, presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint)
• Experience with Clinical Supply Inventory Management systems required
• 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

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Adoption and family-planning benefits
• Volunteer time to participate within your community
• Discretionary year-end shutdown
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Free parking or subsidized commuter passes
• Exclusive preferred pricing on Peloton fitness equipment
• Vacation, sick time and holidays
• Highly competitive and inclusive medical, dental and vision coverage options
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Generous paid time off, including:
• Paid sabbatical after 5 years; every 3 years thereafter
• 401k match and Financial Planning tools
• Location-specific perks and extras!
• Free premium access to fitness, nutrition, and mindfulness classes
• Dedicated care coordination support for our LGBTQ+ community

About Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.

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

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at [email protected]. (EEO/AAP Employer)

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