Director, Clinical Development, Oncology

The Role:
Moderna is seeking a board-certified medical hematologist/oncologist with pharmaceutical experience to lead Clinical Development for one or more of their immuno-oncology-based development programs. Experience in late phase drug development is a plus. This role will report to the Executive Director Clinical Development Oncology and have direct medical responsibility for the 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. There is approximately 10% travel expected as part of this role.

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 immuno-oncology-based new drug candidates in addition to being a highly effective internal and external team player and terrific communicator and collaborator.

Heres What Youll Do:

• Provide clinical leadership for individual programs at the Project Team Level including serving as key representative for clinical development/medical strategy areas both internal and external facing (e.g. CRO KOL and clinical site staff).
• Serve as cross-functional leader on all Medical and clinical work streams including clinical pharmacology statistics clinical operations regulatory affairs and preclinical science and translational medicine.
• Responsible for the design and development of clinical development plans study protocols and interpretation and analysis of clinical study safety and efficacy data including review of the pre-clinical package. Responsible for Investigator Brochures Clinical Study Reports regulatory submissions and responses and other program documents. Along with Clinical Operations is responsible for oversight of study enrollment and overall timelines for key deliverables.
• Act as subject matter expert on all clinical and medical strategic initiatives for their programs.
• Primary responsibility for preparations of external meeting abstracts posters presentations related to clinical trial data.
• Consult with external and internal subject matter experts to agree go/no-go development decision criteria.
• Implement safety strategy across studies including regular review of safety data (including but not limited to SAEs) and response to safety issues.
• Lead clinical sections of regulatory documents (e.g. IND DMF and BLA/NDA) prepare for meetings with FDA and healthcare authorities and organize and prepare for Advisory Board meetings.
• Implementation of clinical trials with adherence to cGCP and FDA Regulatory compliance.
• May participate in due diligence or other business development activity. As required by program needs contributes in partnership with Discovery colleagues to design and implementation of translational strategies.
• Develop and maintain strong collaborative relationships with key stakeholders in Clinical Development and the broader Moderna organization.
• Represent the Company externally to Investigators trial site administrators and sit on Joint Development Committee for programs performed in collaboration with other Pharma companies.

Heres What Youll Bring to the Table:

• Medical Doctor (M.D.) or non-US equivalent of M.D. degree with relevant hematology and/or oncology in an academic or hospital environment. Completion of a residency program strongly preferred. Completion of a pediatric or medical hematology and/or oncology fellowship is desirable.
• Minimum 3 years experience in immune-oncology or oncology clinical drug development preferably in a pharmaceutical or biotechnology company as well as significant knowledge and experience in the design and execution of clinical trials. Background working in development programs that heavily integrate translational medical approaches a must.
• 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.
• Understanding of the entire drug development process including clinical and non-clinical study design and execution.
• Experience in early-stage programs.
• Experience in leading the selection and oversight of CROs and other vendors.
• 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.
• Experience in regulatory cGCP inspections and audits.

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.

Pay & Benefits

At Moderna we believe that when you feel your best you can do your best work. Thats why our benefits and well-being resources are designed to support youat 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

The salary range for this role is $183800.00 - $330300.00. 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 individuals 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.

If you want to make a difference and join a team that is changing the future of medicine we invite you to visit to learn more about our current opportunities.

Equal Opportunities

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons 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 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

Were 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 .

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 applicants 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. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. #LI-AH2

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Required Experience:

Director