Associate Director, CMC Clinical Portfolio Operations

The Role:

CMC Clinical Portfolio Operations (CPO) is a newly created team, designed to establish and deploy a robust and integrated CMC clinical program management framework to enable consistent and scalable methodologies across an increasingly complex clinical development portfolio. The Sr. Manager of Portfolio Operations will be an integral part of the CMC program team, participating in management of portfolio systems, analytics, and strategy execution across all CMC clinical programs to ensure coordination of the clinical programs from early development to launch. This role will be accountable for supporting new systems, metrics, and reporting, that will guide best practices, operating models, and structure across the CMC portfolio.

The role will require someone with a clinical development background who is a hands-on individual contributor that will build relationships at all levels of the organization to support the CPO organization to make well-informed decisions around governance, metrics, process improvements and opportunities to excel. He/she should be expected to develop, implement, and support new tools and practices that maximize business value and efficiencies. To be successful, you must possess strong communication skills and work collaboratively in a highly cross-functional across CMC PMs/PLs, Technical Development, GMP Operations, Supply Chain, Finance, HR, CMC and R&D Strategy.

The role is based in Moderna’s new Moderna Technology Center campus in Norwood, MA.

Here’s What You’ll Do:

• Work with CMC leadership to document governance, tools, and mechanisms cross-functionally to enable best practices and efficient management of the portfolio

• Collaborate with stakeholders to define prioritization, identify gaps/risks, resource allocation and decision-making frameworks to ensure CMC achieves portfolio milestones

• Create, manage, and improve CPO processes to enable portfolio management of CMC activities and long-term planning

• Assist in implementation of portfolio governance, tools, processes, and systems

• Partner with PMs/PLs to document CMC clinical portfolio operations templates and strategies

• Prepare status reports for project review forums and communication to senior management

• Identify and implement best practices to facilitate standardization and coordination across disciplines, functions and/or programs.

• Provide direct and effective project communication to ensure that all stakeholders and are fully informed and knowledgeable of project activities and their status.

• Contribute to innovative approaches related to data reporting, availability, and transparency based on best-practice dashboards, metrics, and other relevant reporting mechanisms

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

• Bachelor’s degree and minimum 10 years of relevant (including clinical development program management) industry experience. MS or MBA preferred.

• Experience applying principles, concepts, practices, and standards of pharmaceutical project management, drug development and manufacture.

• Cross-functional leadership skills – proactive ownership, prioritize & execute, inspire creativity, drive accountability

• Proven results-orientation with strong influencing, problem solving, and negotiation skills that will drive accountability and who has a proven ability to build relationships and influence individuals across all levels in the organization.

• Advanced life-science degree strongly preferred.

• Expert knowledge of drug development and manufacturing processes with proven track record in biopharmaceutical program management.

• Strong working knowledge of key disciplines within CMC and their interdependencies and potential frictions at each major stage of drug development and manufacture.

• Ability to work quickly, assess fluid situations, assimilate key data, recognize key variables, analyze complex situations and make quality judgements.

• Excellent interpersonal, organizational, written and verbal presentation skills along with ability to work collaboratively and build rapport across a matrixed environment

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 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.

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