Clinical Supplies Project Manager

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.

Heres What Youll 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

• Assist in development of IRT requirements, user acceptance testing, and management

• Assist with 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

Heres What Youll Bring to the Table:

• At least 3 - 6 years of clinical drug supply management/clinical supply chain/Clinical Supplies experience in a clinical research environment is preferred

• Bachelors degree in a science-based subject

• Prior Cold Chain packaging, labeling, distribution experience preferred

• IRT design and management experience preferred

• 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

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

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

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission, values, and mindsets every day, our peopleare the driving force behind our scientific progress and our culture.Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

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. Were 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 contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)

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