Executive Director, Clinical Safety And Risk Management, Infectious Disease Therapeutic Area

The Role:

Moderna is seeking an experienced, versatile, pragmatic, and dynamic Executive Director Safety Physician Leader to help lead a Clinical Safety and Risk Management (CSRM) team of physicians in the Infectious Disease Therapeutic Area. The ideal candidate will be a seasoned safety professional with extensive medical expertise, drug disease insight, regulatory knowledge, and leadership abilities in a matrix organization. This individual will be responsible for supporting the safety strategic direction, oversight and management of clinical trial safety and post marketing safety programs throughout the vaccine lifecycle with a focus on Moderna's high priority respiratory vaccine programs. Research and industry experience in vaccine development is a plus. S/he will function as a coach player with a willingness to coach and mentor other safety physicians as well as make individual contributions to safety deliverables and will be as member of the CSRM Infectious Disease Therapeutic Area Physician Leadership Team.

This role will report to Moderna's CSRM VP and Head, Infectious Disease and will be one of the primary point persons for the clinical safety development strategy. The successful candidate is driven, curious, collaborative, with a bold ambition to contribute to the development of ground-breaking mRNA-based vaccines.

Here's What You Will Do:

Medical and Scientific Expertise:

• Provide medical and scientific expertise in evaluating and interpreting safety data from clinical trials, spontaneous reports, and literature.

• Oversee the assessment of patient safety and benefit-risk balance, including risk management and mitigation strategies.

• Maintain up-to-date knowledge of disease states, treatments, and emerging therapies relevant to the company's products.

• Ensure compliance with international and national regulatory frameworks and guidelines governing pharmacovigilance.

• Lead the preparation and review of aggregate safety reports, risk management plans, and benefit-risk assessments throughout the product lifecycle.

• Oversee submission filings, particularly related to safety, ensuring knowledge of regulatory requirements and strategic responses to regulatory authorities' queries.

• Oversee signal evaluations and conduct benefit-risk assessments using data from clinical trials and post-marketing surveillance, integrating diverse data sets for comprehensive safety insights.

• Oversee timely and transparent risk communication of Moderna products under the infectious disease TA to patients, participants, health authorities, IRBs/ECs.

• Foster a culture of continuous learning and adaptability to stay current with medical knowledge, pharmacovigilance practices, and regulatory updates.

Leadership and People Management:

• Build, manage, and mentor a high-performing CSRM team, fostering professional development and succession planning.

• Lead a team of safety physicians, fostering a positive work environment, and effectively communicating to achieve common goals.

• Demonstrate strong strategic thinking, decision-making, problem-solving, and relationship-building skills, managing resources and priorities effectively.

• Communicate effectively with diverse cultural backgrounds, adapting behaviors to foster inclusive interactions.

• Maintain professionalism and resilience under pressure, demonstrating emotional regulation and stress tolerance.

• Commit to ongoing education and adaptability, embracing changes in the regulatory environment and healthcare landscape.

• Contribute to the writing of manuscripts and publications.

• Comply with Moderna SOPs and adhere to ICH, GCP, and relevant regulatory guidelines.

• Provide safety leadership for internal audits and regulatory inspections.

• Assist in preparations of materials and provide key support and participation for Advisory Board meetings.

• Develop and maintain strong, collaborative relationships with the broader Moderna organization.

Here's What You Will Bring to the Table (Qualifications):

• MD, DO or non-US equivalent of MD degree (M.B.B.S.; M.B., Ch.B., etc.) with completion of residency training or graduate training in medicine, public health, epidemiology, infectious disease, pharmacology, toxicology, clinical research, or related topics.

• Minimum of 10 years of experience in drug/vaccine safety or pharmacovigilance within the pharmaceutical industry.

• Minimum of 5 years' experience in managing direct reports.

• Sound medical judgement and expert-level competency in evaluating adverse events and vaccine/drug safety profiles.

• In-depth knowledge of international and national regulatory frameworks governing pharmacovigilance.

• Proficiency in synthesizing, integrating and summarizing safety data in regulatory documents.

• Strong leadership skills with the ability to influence and guide teams as a coach-player.

• Excellent communication, negotiation, change management and conflict resolution skills.

• Ability to remain composed and effective under high-pressure situations.

• Willingness to engage in continuous learning and embrace innovation.

• Ability to thrive in a fast-paced environment.

• Attention to detail, internal drive to generate high-quality work, and sense of passion and urgency to achieve team and program goals.

• Excellent analytical, problem-solving, and strategic planning skills.

• Strong interpersonal skills commensurate with the need to work closely with CROs, investigators, consultants, and team members across functions.

• Exceptional written and oral communication skills to meet the needs of varied audiences.

• Integrated understanding of FDA, EMA, ICH, and GCP guidelines. Prior interactions with FDA and EMA regulatory agencies are desirable.

• Alignment with the Moderna mind-sets

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 leavesandaccommodations@modernatx.com. (EEO/AAP Employer)