CMC Clinical Portfolio Operations is a newly created team, designed to establish a robust and integrated CMC clinical program management framework to enable consistent and scalable methodologies to deploy across an increasingly complex clinical development portfolio. The Program Lead will be an integral part of the CMC program team, managing activities across all CMC functions and will partner closely with functional team leaders to ensure accountability for management, coordination and supervision of the programs transitioning to development through to the launch space for both internal and partnered programs. Over time, this partnership will evolve to formal accountability for establishing best practices, operating models, and structures across CMC to improve CMC program management. They will also prepare project team and steering committee materials related to their assigned projects and ensure project work complies with established practices, policies, and processes. Project issues and risks must be anticipated, identified, and tracked. Plans to resolve these issues must be developed and solutions executed.
The role will require someone with a product development background who is a hands-on individual contributor, that will quickly build relationships at all levels of the organization in order to make well-informed decisions around process improvements and opportunities to excel. We are looking for a leader who can enhance our team with their knowledge, skills, innovation and can do attitude. He/she should be able to recommend, develop, implement, and support new practices that maximizes business value and efficiencies. To be successful, you must possess strong communication skills and work collaboratively in a highly cross-functional across CMC PMs, Technical Development, GMP Operations, Supply Chain, Finance, HR, CMC, and R&D Strategy.
The role is based in Modernas new Moderna Technology Center campus in Norwood, MA.
Heres What Youll Do:
Represent CMC on the Moderna Program teams and lead the cross-functional CMC project team with TD leads and CMC PMs to manage align on CMC activities and timelines.
Partner with TD leads to develop and execute the CMC clinical strategy across the portfolio.
Work with CMC leadership to develop tools and mechanisms focused on defining prioritization, resource allocation and decision-making frameworks to ensure CMC achieves timelines and quality milestones.
Prepare status updates for project review forums and communication to senior management.
Work with CMC PMs to execute the strategy: align on project plans, manufacturing, scheduling and supply.
Identify and implement best practices in order to facilitate standardization and coordination across disciplines, functions and/or programs.
Proactively identify gaps/risks and work with internal teams to develop and implement mitigation plans/corrective actions and escalation pathways, which pose challenges to achieving strategic goals.
Direct and effective project communication to ensure that all stakeholders (internal project teams and external partners) and are fully informed and knowledgeable of project activities and their status.
Drive innovative approaches related to data reporting, availability and transparency based on best-practice dashboards, metrics, and other relevant reporting mechanisms
Heres What Youll Bring to the Table:
Bachelors degree and minimum 15 years of relevant (including clinical development program management) industry experience. MS or MBA preferred.
Extensive 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 at 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.
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.