Executive Director, Clinical Development, Oncology

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. 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.

Here’s What You’ll Do

• 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.

Scientific Leadership, Direction and Strategy

• 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.

Study & Program Design and Evidence Generation

• 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.

Creating Innovative Scientific and Technical Solutions

• 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.

Here’s What You’ll Need (Basic Qualifications)

• 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. 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).
• 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 href="https://www.modernatx.com/en-US/careers/life-at-moderna">modernatx.com/careers to learn more about our current opportunities.

  Our Working Model

  As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.

  Moderna is a smoke-free, alcohol-free, and drug-free work environment.

  Equal Opportunities

  Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

  Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.

  Accommodations

  We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.

  Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com.

  Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Only U.S. persons (U.S. citizens, U.S. lawful permanent residents, asylees, or refugees) are currently eligible to access such information without an export license. Candidates who do not meet these criteria may still be considered, contingent on the company’s ability to obtain any required export control license. #LI-AG2

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