Executive Director, Translational Medicine, Rare Diseases

The Role:Moderna is seeking an innovative, highly collaborative, strategic, and effective translational medicine leader to establish the translational medicine function for our exciting and transformational rare disease mRNA therapeutics pipeline.This position is based in the new Translational Medicine function in our growing Therapeutics & Oncology development organization in R&D at Moderna.In this role, you will develop robust plans to thoroughly understand mechanism of action, pharmacology, tissue localization/targeting, and patient population for promising experimental therapeutics and inform mRNA platform learningsThe ideal candidate will have an advanced degree(s), and pharmaceutical and/or significant biotechnology experiencedeveloping drug candidates in the clinic, and experience developing drugs for metabolic and other serious rare diseases.Experience in the development and submission of documents to health authorities and response to health authority inquiries a plus.This important leadership role will partner with a talented and highly cross functional matrix team comprised of program leaders, medical directors, nonclinical and DMPK scientists, discovery research scientists, regulatory, clinical operations, clinical pharmacology and pharmacometrics, program management, and clinical biomarker assay partners to develop and execute the translational strategy to ensure and accelerate robust and successful clinical development, inform go/no go decision making, successful health authority filings, scientific publications, post-marketing and lifecycle support as needed. The candidate will be a highly effective internal and external team player, communicator, and collaborator.The ideal candidate will be a scientific innovator, problem solver, exceptional matrix and people leader, and thrive in our proactive mission driven, can-do culture that removes viscosity wherever possible to help advance our medicines with speed and rigor to patients with high unmet medical needs.This position is ideally based in our Cambridge, MA headquarters.Approximately 10% travel is expected in this role.Here's What You'll Do:Develop and implement the rare disease translational medicine strategy across the portfolio, including developing and communicating translational questions, hypotheses, recommendations regarding study design, endpoints (including novel endpoints), safety evaluation, dose, pharmacology and PD biomarkersServe as a strategic partner for Program Team Leads to ensure efficient development and implementation of all key translational deliverables and provides frequent project status updates to the cross-functional development teamsWork with key matrix partner functions to define our integrated development plans, including the assessment of unmet medical need, proposal of clinical development pathways, and interpretation of preclinical data to aid in clinical study designWork vertically across Research and Development to define the clinical translational strategy and delivery plan well in advance of IND submission to ensure program readiness and successDevelop and lead the reverse translation of our clinical studies to better enable research and development, as well as platform learningsIdentify and work to validate novel endpoints for early go/no go decision making, accelerated approvals, and refine clinical study patient populations to support rapid demonstration of safety and efficacy and clinical proof of conceptProvide translational leadership to early and late development project teamsWork closely with scientists in research and with biomarker experts in development to align preclinical and clinical biomarker strategies to meet or exceed program needsConsult with external and internal subject matter experts to all major go/no-go development decision criteria to enable best decisions for the program.Partner with Clinical Biomarkers Lead(s) to define an implementable assay strategy for clinical stage programs, including design and writing, as well as authoring the biomarker sections of Investigator Brochures, Clinical Study Protocols and Reports, program documents, regulatory submissions and responses (INDs/CTAs) as well as co-authoring, assisting and supporting the development of publications, abstracts, and presentations.Partner with biostatisticians, computational, and biomarker experts to ensure delivery and interpretation of high-quality data to support internal decision-making and health authority filingsMust be able to manage multiple projects and deliverables across R&D, including assessment of workload, prioritization, and resourcing requirements to deliver the program team's objectivesAs a member of the translational medicine leadership team, shape the future of the translational medicine function at ModernaHere's What You'll Bring to the Table:Advanced scientific degree (MD, PhD, DVM, PharmD), with a minimum of 8 years of relevant work experience developing translational medicine strategies, developing and testing hypotheses in the clinic, biomarker identification and development, biomarker data interpretationA strong background in translational medicine, biomarker identification, experimental design, clinical biomarker data analysis and interpretation, development of high impact scientific publicationsA robust external network of scientific thought leaders and biomarker partner relationshipsProficiency in emerging diagnostic and biomarker technologiesOutstanding verbal and written communication skills, problem solving, and excellent interpersonal partnering and influence skills, ability to mentor scientists around the enterpriseDemonstrated track record in leading successful cross-functional teams and work streams that overcome obstacles to deliver for the enterpriseA thorough understanding of the drug development process, including non-clinical and clinical study design, preclinical experiments, clinical protocol development, clinical study delivery, clinical study reportsExperience partnering with commercial and medical affairs to develop translationally informed target product profiles and medical educationModerna 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) -