Executive Director, Clinical Development, Oncology

About the role

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.

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.

Requirements

• Medical oncologist with 10+ years’ experience in clinical development, with at least 5 years in the biopharma industry, or M.D. with at least 8 years of experience in oncology drug development in the biopharma 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.
• Experience working in development programs that heavily integrate translational medical approaches is preferred.
• 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 to facilitate innovative and efficient clinical trial design and clinical development plans with clear data-driven decision rules.

Qualifications

• 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.

Skills

• 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.

Benefits

At Moderna, we believe that when you feel your best, you can do your best work. That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.

Pay

The salary range for this role is $243,100.00 - $437,000.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.