Senior Director, Clinical Development, Oncology

ModernaTX • Princeton, MA

6d • Onsite

About The Position

The Role: Moderna is seeking an experienced oncology drug developer lead Clinical Development for one or more mRNA-based precision immunotherapies. Experience is 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 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 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 precision immunotherapies. In addition, we are seeking a highly-effective internal and external team player with excellent communication skills. Here’s What You’ll Do: 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 Scientific 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 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 Study & 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 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 Creating Innovative Scientific and Technical Solutions: 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

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.
• 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.
• 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

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

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: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees