Sr. Director, Product Management, Clinical Biomarkers

The Role

Moderna, a leader in groundbreaking mRNA medicines, is seeking a seasoned and dynamic Senior Director of Product Management to lead the development of innovative software solutions that support and enhance our Clinical Biomarkers function. In our Information Systems and Technology division, you will have the unique opportunity to improve the management of clinical sample storage, biomarker assay execution and reporting, as well as the manufacturing of clinical kits for our clinical candidates. Join our dedicated team and make a lasting impact on global healthcare by optimizing our Clinical Biomarkers capabilities.

The Clinical Biomarkers function is responsible for the efficient handling, storage, retrieval, and processing of clinical samples, assay data, and reporting of results. Furthermore, it is responsible for the manufacturing of clinical kits. By driving the development of advanced software tools tailored to the needs of the Clinical Biomarkers team, this role will facilitate the automation of lab processes, enhance data management, and support the effective decision making involved in the clinical development of mRNA medicines.

Heres What Youll Do

• Develop and execute a comprehensive strategy and vision for software solutions that support and enhance the Clinical Biomarkers function, ensuring alignment with Moderna's goals and objectives.

• Oversee the management and maintenance of clinical biomarker software systems such as LabVantage LIMS, evaluating their effectiveness and identifying areas for improvement.

• Lead the design, development, and management of custom applications and AI models that address the unique needs of the Clinical Biomarkers function, including lab automation.

• Collaborate closely with the broader R&D Informatics Systems and Technology team, Clinical Biomarkers stakeholders, and other functional areas to identify product requirements and address the evolving needs of the function.

• Build, lead, and mentor a high-performing product management team focused on advancing the Clinical Biomarkers function.

• Partner with cross-functional teams, including engineering, design, and data science to deliver high-quality software products on time and within budget.

• Continuously analyze user feedback, industry trends, and the competitive landscape to prioritize and refine product features and functionality.

• Implement best practices in product development, management, and lifecycle planning aligned with the Clinical Biomarkers function's needs.

• Drive the adoption and promotion of Agile methodologies throughout the product management process.

• Foster an environment of continuous innovation and technology adoption, with a focus on lab automation, to maintain Moderna's competitive edge within the industry.

• Establish strong relationships with third-party vendors and partners for product development, support, and integration with systems that streamline clinical samples storage, assay processing, and result reporting, as well as clinical kit manufacturing.

• Regularly report on product performance, success metrics, and key insights to executive leadership and stakeholders.

Heres What Youll Need (Minimum Qualifications)

• Bachelors degree in biotechnology, Engineering, Computer Science, Information Systems, Business, or related field

• At least 12 years of experience in product management or a related field, with a minimum of 8 years in a leadership position.

• Experience with clinical biomarker software systems and solutions, ideally LabVantage LIMS.

• Experience with typical clinical biomarker assays such as immunogenicity, flow cytometry, qPCR, LCMS, PK, and NGS.

• Experience in lab automation and its associated technologies, ideally Hamilton liquid handlers and Thermo Fisher inSPIRE.

• Experience delivering GxP-compliant applications with a strong understanding of computer systems validation and compliance with regulatory requirements such as 21 CFR Part 11.

Heres What Youll Bring to the Table (Preferred Qualifications)

• Advanced degree in a relevant life sciences field preferred.

• Demonstrated success in managing large-scale software products, preferably in the life sciences or pharmaceutical industries.

• Deep knowledge of clinical sample storage, lab management, assay, data processing and reporting, and clinical kit manufacturing.

• Strong understanding of software development methodologies, including Agile practices.

• Proven track record of successfully leading cross-functional teams in developing and launching innovative products that drive value and impact.

• Exceptional problem-solving, organization, and communication skills.

• Ability to independently handle multiple tasks, prioritize them effectively, and deliver on tight deadlines.

• Demonstrated capacity to mentor team members and foster professional growth.

• Experience working with AI models and a solid understanding of data science concepts.

• Passionate about driving positive outcomes for patients and committed to Moderna's mission of innovating mRNA medicines.

• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless,

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

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 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 make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)

-