Senior Director, Oncology Clinical Development, Early Phase

About the role

Moderna is seeking an experienced oncology drug developer 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 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.

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.

Requirements

• 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.
• 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.

Qualifications

• 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.
• Thorough understanding of the entire drug development process, including clinical and non-clinical study design and execution.
• 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.

Skills

• Expertise in inductive and deductive reasoning, statistics, and in providing mechanisms to interpret and analyze highly complex information including digital content.
• Strong analytical, problem-solving and strategic planning skills.
• Ability to thrive in a fast-paced environment.
• Embody Moderna’s core values of Bold, Relentless, Curious and Collaborative.

Benefits

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

Pay & Benefits

The salary range for this role is $210,900.00 - $379,200.00. 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. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

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.

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. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position.