Associate Director, Oncology, Translational Medicine

The Role:

Moderna is seeking a Translational Medicine Scientist to play a pivotal role in bridging the gap between preclinical research and clinical application to accelerate the development of groundbreaking therapies. This Translational Medicine role is focusing on next generation mRNA therapeutics in Oncology. The role will work with a cross functional team (medical directors, nonclinical and discovery research scientists, regulatory, clinical operations, biostatisticians, bioinformaticians and clinical pharmacologists) to develop translational strategies and help oversee the execution of these strategies for pre-clinical and clinical stage assets. Position is ideally based in Cambridge, MA headquarters.

Here's What You’ll Do:

• Work across Research and Development to define translational medicine strategy for oncology assets, including making recommendations regarding indications, endpoints, study design, safety evaluations and dose selection.

• Identify and seek to validate novel endpoints for early (pre-POC) decision making and identify patient or target population stratification strategies to support rapid demonstration of safety and efficacy.

• Develop and lead reverse translational strategy to further inform research and development.

• Work closely with other matrix functional areas to define key aspects of the integrated development plans, including the assessment of medical need, proposal of clinical development pathways, and review of preclinical data for clinical implications.

• Collaborate with Biomarkers Lead(s) to define strategy for clinical stage programs, including design and writing, as well as authoring the biomarker sections of Investigator Brochures, Clinical Study Protocols and Reports, program documents, regulatory submissions, and responses (INDs/CTAs) as well as co-authoring, assisting, and supporting the development of publications, abstracts, and presentations.

• Partner with biostatisticians and biomarker experts to ensure high-quality data to support analysis, interpretation, and reports for internal decision-making.

• Works with program team leads to ensure efficient implementation of all key deliverables and provides frequent project status updates to the cross-functional development teams.

Here’s What You’ll Do (Basic Qualifications):

• Advanced scientific degree in a relevant scientific field (Ph.D., Pharm.D. or MD) preferred, with minimum 5 years of relevant work experience developing biomarker and translational medicine strategies.

• A strong background in Oncology, Immunology, and experience in translational medicine.

• Proficiency in emerging diagnostic and predictive biomarker technologies is a plus.

• Innovative problem-solving skills with a focus on complex scientific challenges.

• Advanced communication skills for effective negotiation and stakeholder engagement.

• Demonstrated track record in leading cross-functional teams and work streams (e.g., translational medicine, biostatistics, regulatory, pharmacology, clinical and immunogenicity assay development)

• Understanding of the entire Oncology development process, including clinical and non-clinical study design, use of immunologic surrogates, assay development and importance of target product profile.

Impact and Influence:

• This role is instrumental in shaping our translational strategies for both preclinical and clinical development programs and will have a significant impact on the success of our product pipeline. 

Working Relationships:

• The Clinical Translational Strategy Lead will collaborate closely with R&D, Biomarkers, Biostatistics, and other key departments to drive project success. 

• Will be the leader of the translational sub team within program development teams.

Opportunities for Growth: Moderna offers a dynamic career path with opportunities for professional growth and development in an environment that fosters innovation and collaboration. 

Application Instructions: To apply, please submit your resume and a cover letter detailing your relevant experience and interest in the role. 

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.

• Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Lifestyle Spending Accounts to personalize your well-being journey