Executive Director, Clinical Development - Oncology

The Role:Moderna is seeking a board-certified medical hematologist/oncologist with pharmaceutical experience (or M.D. with oncology drug development experience) to lead Clinical Development for one or more of their immuno-oncology-based development programs, including programs that are malignant hematology focused. Experience in early phase drug development is a plus. This role will report to the Head of Clinical Development in Oncology, for Moderna and have direct medical responsibility for the clinical development programs including creating overall clinical development plans, designing clinical studies, writing protocols, ensuring timely execution and medical monitoring all in close collaboration with relevant internal and external pharmaceutical partners and Clinical Research Organizations.The successful candidate will thrive in a proactive can-do culture and enjoy working across the full range of clinical development activities for the ground-breaking, mRNA-based immuno-oncology-based new drug candidates in addition to being a highly-effective internal and external team player and terrific communicator and collaborator.Here’s What You’ll Do:Providing integrated and innovative clinical development strategy to support 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 appropriateAssessing and predicting when therapies designed for one patient population/indication can be used in alternative scenarios to broaden potential patient benefitAnticipating 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:Board Certification in medical hematology and/or oncology with 10 years’ experience in clinical development with at least 5 years in the biopharmaceutical industry, or M.D. with 8-10 years of experience in oncology drug development in biopharmaceutical industryExperience in immune-oncology or oncology clinical drug development, preferably in a pharmaceutical or biotechnology company, as well as significant knowledge and experience in the design and execution of clinical trials. Background working in development programs that heavily integrate translational medical approaches a must.Demonstrated track record in leading cross-functional teams and work streams (e.g., translational medicine, biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences)Outstanding verbal and written communication skills, in addition to excellent organizational skillsUnderstanding of the entire drug development process, including clinical and non-clinical study design and executionThorough 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 rulesOversee activities leading to internal cGCP audits and regulatory inspections related to clinical trial conductThorough command of FDA, MHRA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies in the United States, Europe and rest of worldAttention to detail, internal drive to generate high-quality work, and sense of passion and urgency to achieve team and program goalsDemonstrated experience managing complex projects and working collaboratively with multiple stakeholders regarding new strategies to ensure consistent communicationDemonstrated 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 contentExcellent analytical, problem-solving and strategic planning skillsAbility to thrive in a fast-paced environmentEmbodies Moderna’s core values of Bold, Relentless, Curious and Collaborative.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.

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