Associate Director, CMC Project Management

The Role:

In this role, the Associate Director, CMC Project Management will be responsible for leading the CMC project planning and management activities of clinical development programs encompassing lead nomination to BLA planning/execution. They will be responsible for owning a project planning portfolio of CMC development programs while also managing and mentoring project managers. They will work closely with the CMC Program Lead(s) to develop and align on project plans, manage CMC project teams and timelines to execute on assigned programs, support program teams as assigned, prepare regular reports to the Clinical Planning Operations (CPO) team, and to CMC leadership, and provide alliance management support for assigned partnered programs.

Heres What Youll Do:

• With the CMC Project Lead(s) establish, manage and lead cross-functional CMC project teams for assigned programs

• Manage and mentor CMC Project managers

• Develop integrated CMC project plans for assigned programs, work with CPO portfolio operations, CMC Project Leads and CMC leadership to ensure project plan alignment with portfolio priorities and capacity

• Generate project status and risk reports for CPO and CMC leadership; support reporting to Executive Committee

• Assist with the development, implementation and maintenance of CPO business processes

• Represent CMC Project Management on Early and Late Stage Technical Development Team(s), program teams and governance meetings as assigned

Heres What Youll Bring to the Table:

• Education: University degree in an appropriate discipline (e.g. sciences, engineering, business)

  • Advanced degree (MS, Ph.D., MBA), and/or PMP is preferred, but not required

• Minimum 10 years of Project Management in Pharmaceutical/Biotechnology, or related industries

• Strong understanding of pharmaceutical or biotech product development, particularly in the planning and execution of CMC activities supporting clinical development

• The successful candidate will have demonstrated experience in leading cross-functional development teams in both early and late stages of pharmaceutical/biotech product development

  • Ability to work in a fluid environment and foster a strong collaborative spirit

  • Ability to negotiate and sustain networking relationships

  • Solid judgement with ability to make good decisions

  • Strong knowledge of project management tools/software, and digital solutions

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 winter shut down
  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!

Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

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 committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons 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.

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