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Moderna · 1 month ago

Senior Director, Clinical Development, Oncology

Cambridge, Massachusetts

Full-time

Hybrid

Lead/Staff, Director/Executive

$211K/yr - $379K/yr

3+ years exp

Moderna is seeking an experienced oncology drug developer to lead Clinical Development for mRNA-based precision immunotherapies. This role involves creating clinical development plans, designing studies, and collaborating with various partners to ensure successful execution and monitoring of clinical programs.

BiotechnologyGeneticsHealth CareMedicalPharmaceuticalTherapeutics

Comp. & Benefits

No H1B

U.S. Citizen Only

Responsibilities

Collaborate in the development and execution of the Clinical Development Plan (CDP) for assigned oncology assets

Integrates scientific rationale, regulatory requirements, product development plan and commercial goals to optimize clinical study designs aligned with the Integrated Development Plan (IDP) and CDP

Generates 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 timeframe

Establishes 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 as needed

Contributes to and partners with the development of strategic initiatives, such as organizational initiatives within Clinical Development

Plays an active role in the technical and leadership development of Clinical Scientists

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 compounds

Able to lead and influence 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 need

Integrates 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 appropriate

Evaluates therapies designed for one patient population/indication can be used in alternative scenarios to broaden potential patient benefit

Anticipates problems and proactively seeks input from other team members/functional lines within R&D. Uses scientific/operational expertise to solve study and/or project related problems

Accountable for the evaluation of clinical study/program probability of technical success

Drives the end-to-end integrated clinical development strategy that is appropriately resourced to achieve regulatory approvals, reimbursable medicines, and successful lifecycle management

Leads 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 responses

Delivers value and access insights to inform medical strategy, expand market access and to address unmet patient need

Overcomes obstacles by experimenting with and adopting new ways of working including digital tools and technology

Champions implementation of innovative methods and processes within clinical development and gains stakeholder support; encourages others to think differently and come up with business solutions

Qualification

Oncology drug developmentClinical study designRegulatory submissionsCross-functional leadershipMedical oncology fellowshipHematology experienceClinical research methodologyBiostatistics principlesStrategic planningCommunication skillsProblem-solving skillsAttention to detailTeam collaboration

Required

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

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 skills

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, to facilitate innovative and efficient clinical trial design, and clinical development plans with clear data-driven decision rules

Oversee activities leading to internal cGCP audits and regulatory inspections related to clinical trial conduct

Thorough command of FDA, MHRA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies in the United States, Europe and rest of world

Attention to detail, internal drive to generate high-quality work, and sense of passion and urgency to achieve team and program goals

Demonstrated experience managing complex projects and working collaboratively with multiple stakeholders regarding new strategies to ensure consistent communication

Demonstrated experience using new learning and digital tools to create innovation in other areas

Expertise in inductive and deductive reasoning, statistics, and in providing mechanisms to interpret and analyze highly complex information including digital content

Excellent analytical, problem-solving and strategic planning skills

Ability to thrive in a fast-paced environment

Embodies Moderna's core values of Bold, Relentless, Curious and Collaborative