Executive Director, Clinical Development, Oncology

Moderna • Cambridge, MA

1d • $243,100 - $437,000 • Onsite

About The Position

Moderna is seeking a senior level clinical development physician (M.D.) with deep oncology drug development experience in the biopharma industry to lead Clinical Development for one or more of our groundbreaking oncology development programs. This role will have direct medical responsibility for key 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 new mRNA-based oncology drug candidates, in addition to being a highly-effective internal and external thought leader, communicator, and collaborator.

Requirements

• Medical oncologist with 10+ years’ experience in clinical development, with at least 5 years in the biopharmaceutical industry, or M.D. with at least 8 years of experience in oncology drug development in the biopharmaceutical industry.
• Experience in immuno-oncology or oncology clinical drug development, as well as significant knowledge and experience leading the design and execution of clinical trials.
• Demonstrated track record in leading cross-functional teams and work streams (e.g., translational medicine, biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences).
• 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.
• Attention to detail, internal drive to generate high-quality work, and sense of passion and urgency to achieve team and program goals.
• Outstanding verbal and written communication skills, in addition to excellent organizational skills.
• Demonstrated experience managing complex projects and working collaboratively with multiple stakeholders regarding new strategies to ensure consistent communication.
• Excellent analytical, problem-solving and strategic planning skills.
• Ability to thrive in a fast-paced environment.

Nice To Haves

• Experience working in development programs that heavily integrate translational medical approaches is preferred.
• Experience leveraging AI, machine learning, and digital technologies to support innovation and advance clinical development capabilities in oncology drug development.
• Expertise in inductive and deductive reasoning, statistics, and in providing mechanisms to interpret and analyze highly complex information including digital content.
• Experience overseeing 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.

Responsibilities

• Provide integrated and innovative clinical development strategy to support the creation and management of the Clinical Development Plan (CDP) for assets in development.
• 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 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 timeframe.
• Establish expeditious clinical development timelines, incorporating key decision points and Go/No Go criteria for the CDP.
• Develop and maintain relationships with program counterparts in Commercial, Research, Regulatory, Clinical Operations and Statistics.
• Contribute to and partner on the development of strategic initiatives, specific Business Development activities and various organizational initiatives in Clinical Development.
• Play an active role in the technical and leadership development of Clinical Sciences staff through coaching and mentoring, with potential direct line management.
• 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 positively interface with, 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 that aligns to the business strategy and achieves mutual goals related to patient need.
• 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.
• Accountable for risk/benefit of the asset.
• Actively lead and make decisions that balance risk/benefit at the project level with clear understanding of impact on study/project indication approvals; take action to mitigate risk where appropriate.
• Assess and predict when therapies designed for one patient population/indication can be used in alternative scenarios to broaden potential patient benefit.
• Anticipate problems and proactively seek input from other teams’ members/functional lines within R&D.
• Use scientific/operational expertise to solve study and/or project related problems.
• 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, BLA, MAA) including briefing documents, presentations, addressing questions and responses.
• Deliver value and access insights to inform medical strategy, expand market access and to 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

• Best-in-class healthcare coverage, 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 investment opportunities to help you plan for the future
• Location-specific perks and extras

What This Job Offers

• Job Type: Full-time
• Career Level: Executive