Director, CMC Product Lead
: Job Details :

Director, CMC Product Lead

Apply locations Norwood, Massachusetts Technical Development time type Full time posted on Posted 3 Days Ago job requisition id R16321

The Role

The CMC Product Lead is a critical strategic role within the CMC organization, tasked with the oversight and execution of CMC strategies for multiple assets across therapeutic areas from first in human to pivotal studies. The CMC Product Lead ensures seamless integration of program strategy with the Target Product Profile (TPP) and Quality Target Product Profile (QTPP), and is responsible for translating Core Team (R&D and/or Commercial) strategies into actionable CMC plans. With a comprehensive understanding of drug development, the role requires technical expertise, leadership skills, and a robust command of situational complexity and ambiguity to effectively manage CMC plans. The CMC Product Lead is expected to thrive in leading through complex situations, demonstrate accountability, engage in cross-functional debate, and embrace differences in opinion. The ideal candidate will display keen judgment, executive presence, and the ability to develop self and team members continually.

Here's What You'll Do

• Define and communicate strategic CMC Development Plans for a franchise of specific products, ensuring alignment with the TPP and QTPP.
• Translate Core Team strategy into actionable, achievable CMC tasks and milestones, prioritizing the portfolio in alignment with enterprise priorities.
• Serve as a key member of Core Team, representing CMC and working under the guidance of the Leadership Team (LT).
• Act as the primary point of accountability for the CMC plan, making critical decisions and serving as a resource to key leadership.
• Engage in technical discussions, own technical roadmap for program implementation and contribute to CMC sections of global regulatory submissions.
• Lead CMC team in discussions with key leadership, R&D teams, and internal governance bodies.
• Identify and address cross-functional gaps and risks, escalating issues appropriately to drive progress.
• Accountable for the strategy of the resource and financial management of the team, including budgeting, resource allocation and cost management.
• Empower and delegate to team members/workstream leads, establishing credibility by diving into the appropriate level of detail when necessary.
• Engage the audience with the right content, balancing engagement based on risk and value.
• Build and maintain strong relationships across the organization, including with cross-functional stakeholders for facilitating strategic handshakes for effective lifecycle management.

Here's What You'll Need (Basic Qualifications)

• MS with a minimum of 10 years, or BS/BA with a minimum of 12 years of relevant experience.
• Strong knowledge of CMC-related activities, including Technical Development, Manufacturing, Supply Chain, Quality, Process Development, and CMC Regulatory.
• Able to work cross-functionally with R&D, Clinical Development, and Commercial teams.
• This role is based in Norwood, MA and is expected to be in office 70% of the time with flexibility to work from home up to 30%.

Here's What You'll Bring to the Table (Preferred Qualifications)

• PhD in relevant field such as Biochemistry, Chemistry, Biology, Pharmaceutical Sciences.
• Demonstrates sufficient technical depth in drug development to inform overall CMC strategy.
• Financial/business acumen and executive influence with strong stakeholder management skills at all levels.
• Demonstrates leadership quality, poise, flexibility, adaptability, and superb written and verbal communication skills.
• Cross-functional influence, negotiation skills, and a champion of effective decision-making processes.
• Considered a thought leader in program strategy and tactics with the ability to operate through complex and ambiguous situations.

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, the infrastructure 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 people are 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. 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 contact the Accommodations team at ...@modernatx.com.

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