Sr. Director, Clinical Development - Autoimmune, Cardiovascular (CV), Pulmonary and Rare Diseases

Company: Moderna Therapeutics
Location: Princeton
Posted on: February 4, 2025

Job Description:

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 (CV), Pulmonary and Rare Diseases, we are driving scientific innovation to deliver transformational medicines.Moderna is seeking an MD with experience in rare disease/immunology clinical development to lead the clinical strategy for one or more assets within the Therapeutic portfolio -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 Clinical Head for Rare Disease, Autoimmune or Exploratory Disease. -The position is based at one of Moderna's offices in: Cambridge, MA; Princeton, NJ; Bethesda, MD. -The successful candidate is driven, curious, and 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: Providing integrated and innovative clinical development strategy to lead the creation and management of the Clinical Development Plan (CDP) for an asset in developmentIntegrating scientific rationale, regulatory requirements, product development plan and commercial goals to optimize clinical study designs aligned with the Integrated Development Plan (IDP) and CDPGenerating the data and evidence required to determine a medicine's potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframeEstablishing expeditious clinical development timelines, incorporating key decision points and Go/No Go criteria for the CDPDeveloping and maintaining relationships with program counterparts in Commercial, Research, Regulatory, Clinical Operations and StatisticsContributing to and partnering on the development of strategic initiatives, specific Business Development activities and various organizational initiatives in Clinical DevelopmentPlaying an active role in the technical and leadership development of Clinical Sciences staff via coaching and mentoring and potential direct line managementScientific Leadership, Direction and Strategy: Employs visioning and strategic thinking to provide expert leadership of disease/therapeutic area specific strategy for a drug(s) or program(s). Leads selected clinical development projects for products/franchise of compoundsLeading and positively interfacing with and influencing across a diverse range of scientific external experts (e.g. regulators, payors, CROs, consultants, investigators) in order to deliver integrated clinical development strategy, which align to the business strategy and achieves mutual goals related to patient needIntegrating inputs from across disciplines (scientific, clinical commercial, regulatory) to contribute to the Target Product Profile. -Accountable for the clinical components of the Target Product Profile.Accountable for risk/benefit of the asset. -Actively leads and makes decisions which balance risk/benefit at the project level with clear understanding of impact on study/project indication approvals; takes action to mitigate risk where appropriateAnticipating problems and proactively seeking input from other teams' members/functional lines within R&D. -Uses scientific/operational expertise to solve study and/or project related problemsAccountable for the evaluation of clinical study/program probability of technical successStudy & Program Design and Evidence Generation: Drives the end to end integrated clinical development strategy that is appropriately resourced to achieve regulatory approvals, reimbursable medicines, and successful lifecycle managementLeads clinical development discussions at regulatory interactions and clinical components of the submissions (e.g. IND, NDA, BLA, MAA) including briefing documents, presentations, addressing questions and responsesDelivers value and access insights to inform medical strategy, expand market access and to address unmet patient needCreating Innovative Scientific and Technical Solutions: Overcomes obstacles by experimenting with and adopting new ways of working including digital tools and technologyChampions implementation of innovative methods and processes within clinical development and gains stakeholder support; encourages others to think differently and come up with business solutionsHere's What You'll Bring to the Table:MD degree and 5 years' experience or advanced degree (Ph.D, pharm D) with extensive experience in clinical development, preferably in rare diseaseAdvanced medical training or experience in an internal medicine or pediatric-related fieldAbility to thrive in a fast-paced environmentAttention to detail, internal drive to generate high-quality work, and sense of passion and urgency to achieve team and program goalsExcellent analytical, problem-solving and strategic planning skillsExtensive 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 in all clinical trial phases.Extensive clinical training and/or applicable clinical research experience; understanding of clinical development planning and running clinical trial from concept study idea to publication.Demonstrated experience managing complex projects and working collaboratively with multiple stakeholders regarding new strategies to ensure consistent communicationProven ability to maximize and integrate genetic data to advance disease understanding and inform and guide clinical development plansThorough 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 rulesDemonstrated experience using new learning and digital tools to create innovation in other areasExpertise in inductive and deductive reasoning, statistics, and in providing mechanisms to interpret and analyze highly complex information including digital contentEmbodies 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 classes -Exclusive 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 parents 401k 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 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) -#LI-TR2-SummaryLocation: Cambridge, Massachusetts; Clinical Development; Bethesda, Maryland; Princeton, New JerseyType: Full time

Keywords: Moderna Therapeutics, Mount Vernon , Sr. Director, Clinical Development - Autoimmune, Cardiovascular (CV), Pulmonary and Rare Diseases, Executive , Princeton, New York