Vp, Clinical Development, Oncology

The Role:Moderna is seeking an experienced and ambitious clinical developer to serve as its Vice President, Clinical Development for its oncology portfolio. The VP will be a bold and creative thinker with an appetite for calculated risk-taking in pursuing novel approaches to drug development. The oncology portfolio represents tremendous potential for Moderna and is a mission-critical component of the company's commitment to enabling the pursuit of a long life well lived for people all over the world. This VP will bring incredible depth within the oncology space, allowing them to effectively support the development of Moderna's oncology portfolio and the attainment of the company's broader and longer-term goals to grow in this important space. They will have direct medical responsibility for the clinical development of the oncology pipeline, including input into the strategy, oversight of clinical development plans, and ensuring timely execution and medical monitoring all in close collaboration with relevant internal and external pharmaceutical partners, Clinical Research Organizations and regulatory agencies. The successful candidate can thrive in a proactive, team-oriented culture. This individual will act with urgency and think expansively about pipeline strategy and potential. The candidate will be a highly effective internal and external team player and be a terrific communicator. The VP will collaborate with colleagues across the company, including those in research and discovery, commercial, and other therapeutic areas.Here's What You'll Do:Provide strategic and clinical leadership for the oncology development portfolio including serving as the key representative for clinical development/medical strategy.Serve as cross-functional strategic leader on all Medical and Clinical work streams in the oncology portfolio, including clinical pharmacology, statistics, clinical operations, regulatory affairs, and preclinical science and translational medicine.Directly lead a dedicated, experienced team of clinicians and clinical scientists responsible for:The design and development of clinical development plans, study protocols and interpretation and analysis of clinical study safety and efficacy data, including review of the pre-clinical package. Responsible for Investigator Brochures, Clinical Study Reports, regulatory submissions and responses pertaining to clinical development, and other program documents. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables.Preparing meeting abstracts, posters, presentations related to clinical trial data for internal management review and external scientific/clinical meetings. Developing risk-based safety monitoring of clinical trials and Implement safety strategy across studies, including regular review of safety data (including but not limited to SAEs) and response to safety issues.Leading clinical sections of regulatory documents (e.g., IND, DMF and BLA/NDA), prepare for meetings with FDA and healthcare authorities and organize and prepare for Advisory Board meetings.Implementation of clinical trials with adherence to cGCP and compliance with FDA, EMA and other relevant national regulatory agency requirements.Consult with external and internal subject matter experts to enable leadership to make the best decisions for the oncology portfolio.Work with the pre-clinical and strategy teams to determine which oncology products to bring forward into the clinic from the research laboratories.Participate in due diligence or other business development activities. As required by program needs, contribute in partnership with Research and Development and Technical Development colleagues to design and implement translational strategies.Develop and maintain strong, collaborative relationships with key stakeholders in Clinical Development and the broader Moderna organization.Here's What You'll Bring to the Table:Medical Doctor (M.D.), Doctor of Osteopathy (D.O.) or non-US equivalent of M.D. degree with relevant training. Board certification is preferred.Minimum 12 years' experience in oncology clinical development, preferably in a pharmaceutical or biotechnology company; understanding of the entire drug development process, including clinical and non-clinical study design, innovative study design platforms, use of digital and importance of target product profile.Knowledge of and experience in the entire development process, including clinical and non-clinical study design.The ability to juggle multiple priorities at once across a broad portfolio of programs.Demonstrated track record in leading cross-functional teams and work streams (e.g., translational medicine, biostatistics, regulatory, pre-clinical pharmacology, clinical and immunogenicity assay development).Broad understanding of the local and global pharmaceutical industry, the competitive landscape, and how the end-to-end life and revenue cycles operate.Demonstrated ability to lead and inspire teams and allocate resources strategically and according to portfolio priorities.Proven ability to manage and develop self and work collaboratively with others to deliver innovative and creative results and solutions.Outstanding verbal and written communication skills, in addition to excellent organizational skills.Experience in leading the selection and oversight of CROs and other vendors.Thorough command of ICH and GCP guidelines to ensure the appropriate ethical conduct of clinical studies in the United States, Europe and rest of world.Experience in regulatory cGCP inspections and audits.Ability to thrive in a fast paced, rapidly evolving environment with little direction.Embodies Moderna's core values of Bold, Relentless, Curious and Collaborative.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 optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classesExclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous 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 thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras!About ModernaSince 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 peopleare 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 ****** . (EEO/AAP Employer) -