Senior Director, Oncology Clinical Development, Early Phase

Moderna • Cambridge, MA

3d • $210,900 - $379,200 • Onsite

About The Position

Moderna is seeking an experienced oncology drug developer to lead Clinical Development for one or more mRNA-based precision immunotherapies. Experience in early-phase development is essential. This role will report to the Head of Early Clinical Development, Oncology and will have direct medical responsibility for clinical development programs. This includes 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 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 groundbreaking, mRNA-based precision immunotherapies. Additionally, we are seeking a highly effective internal and external team player with excellent communication skills.

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• 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 aligned with the Integrated Development Plan (IDP) and CDP.
• Generate 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.
• 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 as needed.
• Contribute to and partner with the development of strategic initiatives, such as organizational initiatives within Clinical Development.
• Play an active role in the technical and leadership development of Clinical Scientists.
• Employ visioning and strategic thinking to 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) to deliver integrated clinical development strategy, aligning with the business strategy and achieving mutual goals related to patient need.
• Integrate inputs from across disciplines (scientific, clinical, commercial, regulatory) to contribute to the Target Product Profile.
• Be accountable for the clinical components of the Target Product Profile.
• Be accountable for the risk/benefit of the asset.
• Actively lead and make decisions that balance risk/benefit at the project level with a clear understanding of the impact on study/project indication approvals; take action to mitigate risk where appropriate.
• Evaluate therapies designed for one patient population/indication for potential use in alternative scenarios to broaden potential patient benefit.
• Anticipate problems and proactively seek input from other team members/functional lines within R&D.
• Use scientific/operational expertise to solve study and/or project related problems.
• Be accountable for the evaluation of clinical study/program probability of technical success.
• Drive the end-to-end integrated clinical development strategy that is appropriately resourced to achieve regulatory approvals, reimbursable medicines, and successful lifecycle management.
• Lead 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.
• Deliver value and access insights to inform medical strategy, expand market access, and address unmet patient need.
• 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 and gain stakeholder support; encourage others to think differently and come up with business solutions.

Benefits

• Competitive healthcare, plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Family planning benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investments to help you plan for the future
• Location-specific perks and extras

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree