Reporting to the Chief Safety Officer, this highly experienced clinical safety physician will be responsible for all aspects of the clinical safety and risk management for all Moderna clinical development programs in the Infectious Disease Vaccines therapeutic area including vaccines for COVID-19, other respiratory viruses (RSV, flu), latent viruses (CMV, EBV) and other viruses impacting public health. This senior safety clinical leader will oversee a team of safety physicians leading the Safety and Risk Management Teams for all products authorized or in development in this therapeutic area and will ensure the optimal continuous assessment of their safety profiles utilizing all available sources of safety data including clinical trials, post-marketing spontaneous safety reports, observational studies, Real World Data/Real World Evidence, and literature reports. In this role, this leader will ensure the proactive and transparent communication of risk information to regulatory agencies, prescribers and patients and will implement effective risk management measures as warranted. This position will work closely cross-functionally with senior leaders supporting these programs in Clinical Development, Regulatory Sciences, Clinical Development Operations, Biostatistics, PV Epidemiology/RWE, PV Operations, and other functions, and will be accountable for overseeing responses to safety queries from regulatory agencies and for the safety portion of regulatory filings. This position will have a high degree of visibility and impact across the organization and will collaborate closely cross-functionally and cross-regionally. This is an exciting time to join Moderna as we deliver the greatest possible impact to people through our mRNA medicines and vaccines; with a proven platform and a large and growing pipeline of products in clinical development Moderna is poised for substantial growth in the upcoming years. This role will be a key contributor to and a member of our Clinical Safety and PV Leadership Team and will have the opportunity to make critical contributions to Modernas future success in making a transformative impact to patients using our mRNA platform.
Heres What Youll Do:
Provide dynamic leadership, strategic direction, and global oversight of all aspects of the clinical safety assessment and risk management of all Moderna clinical development programs in the Infectious Disease Vaccines therapeutic area.
Provide direct oversight to safety physicians supporting programs and leading Safety & Risk Management Teams for clinical development programs in the ID Vaccines TA.
Work closely with our pharmacoepidemiology/RWE staff to ensure the successful design and execution of all observational Post-Authorization Safety Studies for these programs.
Partner closely with senior cross-functional colleagues in developing the strategies and supporting the execution of the clinical development and registrational plans for programs in the ID Vaccines TA.
Represent Clinical Safety and Pharmacovigilance at governance meetings for products in the ID Vaccines TA.
Provide expertise based on extensive prior experience with vaccine development and vaccine safety to support all future Moderna vaccine programs.
Heres What Youll Bring to the Table:
M.D. with a minimum of 10 years of industry experience in vaccine clinical development in relevant areas (Clinical Development, Epidemiology, Medical Affairs, Scientific Affairs), including at least 5 years of senior leadership experience overseeing clinical safety and risk management for vaccine programs.
Extensive experience overseeing and managing vaccine safety both in the pre-authorization and in the post-marketing phase.
Experience in epidemiology and observational research is preferred.
Strong medical and scientific skills and a track record of successful teamwork cross-functionally and cross-regionally.
Experience working with all levels of management and consulting with key business stakeholders, including an ability to influence for greater outcomes.
Excellent interpersonal and communication skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs and recommendations.
Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks while working in a matrixed environment.
Ability to manage multiple deliverables and initiatives in a fast-paced environment.
Ability to combine clinical safety and pharmacovigilance expertise with exceptional leadership (strategic thinking, people, and resource management)
Ability to embrace Modernas culture, values and mindsets.
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!
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 email@example.com. (EEO/AAP Employer)