Senior Director, Clinical Development, Oncology

Collaborate in the development and execution of the Clinical Development Plan (CDP) for assigned oncology assets.,Integrate scientific rationale, regulatory requirements, product development plan, and commercial goals to optimize clinical study designs.,Generate data and evidence to determine a medicine's potential efficacy, safety profile, key areas of product differentiation, and value to patients.,Establish expeditious clinical development timelines, incorporating key decision points and Go/No Go criteria for the CDP.,Collaborate effectively with program counterparts in Translational Medicine, Pharmacometrics, Research, Biostatistics, Clinical Operations, Regulatory, Commercial, and other functional areas.,Contribute to and partner with the development of strategic initiatives within Clinical Development.,Play an active role in the technical and leadership development of Clinical Scientists.,Provide expert leadership of disease/therapeutic area specific strategy for a drug(s) or program(s).,Lead selected clinical development projects for products/franchise of compounds.,Lead and influence across a diverse range of scientific external experts (e.g., regulators, payors, CROs, consultants, investigators).,Integrate 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 and for risk/benefit of the asset.,Evaluate therapies for alternative scenarios to broaden potential patient benefit.,Anticipate problems and proactively seek input from other team members/functional lines.,Accountable for the evaluation of clinical study/program probability of technical success.,Drive the end-to-end integrated clinical development strategy.,Lead clinical development discussions at regulatory interactions and clinical components of submissions (e.g., IND, NDA, BLA, MAA).,Deliver value and access insights to inform medical strategy.,Overcome obstacles by experimenting with and adopting new ways of working, including digital tools and technology.,Champion implementation of innovative methods and processes within clinical development.

Medical Doctor (M.D.), Doctor of Osteopathy (D.O.) or non-US equivalent of M.D. degree with relevant hematology and/or oncology in an academic or hospital environment.,Experience in oncology drug development demonstrated by at least 3 years in the biopharmaceutical industry.,In exceptional cases, at least 5 years of experience as an early-phase clinical trialist in academia would be considered.,Medical oncology and/or hematology fellowship training is preferred.,Experience in oncology and/or hematology immunotherapeutics is preferred.,Experience in conducting translationally rich oncology and/or hematology clinical trials is highly valued.,Demonstrated track record in leading cross-functional teams and work streams (e.g., translational medicine, biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences).,Thorough understanding of the entire drug development process, including clinical and non-clinical study design and execution.,Thorough understanding of clinical research methodology and biostatistics principles.,Oversee activities leading to internal cGCP audits and regulatory inspections.,Thorough command of FDA, MHRA, and ICH GCP guidelines.,Demonstrated experience managing complex projects and working collaboratively with multiple stakeholders.,Demonstrated experience using new learning and digital tools to create innovation.,Expertise in inductive and deductive reasoning, statistics, and in providing mechanisms to interpret and analyze highly complex information.

Medical Doctor (M.D.), Doctor of Osteopathy (D.O.) or non-US equivalent of M.D. degree

Position may involve access to U.S. export control laws (EAR) technology or data.,Employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law.,Only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible.,Moderna is unable to sponsor non-U.S. persons for an export control license for this role.