The Role:Programs in Therapeutics Development are a key part of Moderna's portfolio. Comprising a dynamic & collaborative community of clinical development physicians and scientists across Autoimmune, Cardiovascular, Pulmonary, Hematology, and Rare Diseases, we are driving scientific innovation to deliver transformational medicines.Moderna is seeking aMDwith experience inClinical Developmentto contribute to the clinical strategy for rare disease and oversee a clinical team accountable for trials to execute the strategy. This role offers you the opportunity to utilize advanced scientific and statistical principles and digital technology in collaboration with your peers to help build Moderna's pipeline. This role will report to Moderna's Propionic Acidemia (PA) Clinical Lead (Rare Disease). The position can be based at Moderna's Cambridge, MA site (preferred), or at Moderna's satellite sites in Princeton, NJ and Bethesda, MD.The successful candidate is driven, curious, collaborative, with a bold ambition to contribute to the development of ground-breaking mRNA-based therapeutics. The candidate must have excellent oral and written communication skills, and a collaborative way of working.Here's What You'll Do:Contribute to the PA clinical program strategy to support the creation and implementation of the Clinical Development Plan for an asset in development.Lead the generation of data and evidence required to determine a medicine's potential efficacy, safety profile, key areas of product differentiation and value to patients in the shortest possible timeframe.Develop and maintain relationships with program counterparts in Clinical Operations, Data Management, Safety, Statistics, Research, Regulatory, and Commercial.Act as the medical monitor for one or more trials in collaboration with CRO/key vendors, overseeing participant safety.Scientific Leadership, Direction and Strategy:Serve as the primary medical lead/expert for assigned trials with a hands-on approach; direct oversight of the planning, execution, and management in collaboration with cross-functions.Lead the review and interpretation of clinical trial data (eg, safety, efficacy, PK/PD), to make informed decisions throughout the drug development process;collaborate in the timely review of medical coding and statistical data analysis activities to ensure data accuracy, quality and integrity.Lead/author/contribute to the development of clinical documents to include but not limited to clinical protocols, clinical study reports, medical monitoring plans, biomarkers strategies, statistical analysis plans, pharmacy manual, study-specific plans, informed consent forms.Contribute to operational activities related to successful clinical trial execution including input into country/site feasibility assessments, study site support/communication, monitoring and compliance with required documentation; ensure that medically related Trial Master File documentation is properly maintained.Proactively identify project risks with cross-functional input and makes decisions/takes action using scientific/operational expertise to resolve issues ensuring that any potential delays are fully mitigated; maintain detailed timelines for all medical deliverables; consistent & regular tracking of project timelines to allow full transparency to the senior leadership.Accountable for clinical sections of regulatory documents like IBs, briefing books, safety updates, submission documents (e.g., MAA, BLA, IND), responses to Health Authorities questions and for clinical development discussions at regulatory interactions.Drives the study design to support the clinical development strategy and ensures the study optimizes scientific value, patient focus, and feasibility of execution.Serves as a key external liaison/spokesperson of the clinical program in interactions across a diverse range of scientific external experts (e.g., investigators, regulators, CROs, consultants) in order to deliver thorough clinical study plans.Open to implementation of innovative methods and processes within clinical trial designs and thinks differently to come up with business solutions.Ensure that the highest quality, ethical & professional values are demonstrated in all aspects of the work; ensure compliance with corporate policies and procedures, in addition to all related healthcare laws and regulations.Here's What You'll Bring to the Table:MD degree with completed residency/fellowship training is required.2+ years of direct clinical development experience in industry (biotech/pharma) conducting Phase 1-3 studies is required. Rare disease (Pediatrics) experience highly preferred.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.Experience in clinical drug development with an understanding of multiple diseases, the underlying biology, and potential therapeutic targets as well as current and future potential treatment options.Clinical training and applicable clinical research experience; understanding of clinical. development planning and running clinical trials from concept study idea through publication.Experience managing complex projects and working collaboratively with multiple stakeholders regarding new strategies to ensure consistent communication.Ability to maximize and integrate genetic data to advance disease understanding and inform and guide clinical development plans.Firm understanding of clinical research methodology and biostatistics principles, to facilitate innovative and efficient clinical trial design, and clinical development plans with clear data-driven decision rules.Receptive to championing the use of new learning and digital tools to create innovation.Fundamental knowledge in inductive and deductive reasoning, statistics, and in providing mechanisms to interpret and analyze highly complex information including digital content.Solid knowledge of compliance and global regulatory requirements (ICH) and GCP for development of pharmaceutical candidates/products is required. Working knowledge of US FDA and EMEA regulations is a plus.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.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 make a request to the Talent Acquisition Partner or contact the Accommodations team at ****** . (EEO/AAP Employer) -
