Associate Director, Oncology, Translational Medicine

Role Summary

Associate Director, Oncology, Translational Medicine. Role focuses on bridging preclinical research and clinical application to accelerate development of next-generation mRNA therapeutics in Oncology. Works with a cross-functional team to develop translational strategies and oversee execution for pre-clinical and clinical assets. Ideally based in Cambridge, MA.

Responsibilities

• Define translational medicine strategy for oncology assets, including indications, endpoints, study design, safety evaluations, and dose selection.
• Identify and validate novel endpoints for early decision making and stratification strategies to support rapid safety and efficacy demonstration.
• Develop and lead reverse translational strategies to inform research and development.
• Collaborate with matrix functional areas to define integrated development plans, assess medical need, propose clinical development pathways, and review preclinical data for clinical implications.
• Collaborate with Biomarkers leads to define strategy for clinical programs, including design/writing of biomarker sections of Investigator Brochures, Clinical Study Protocols and Reports, regulatory submissions, and supporting publications and presentations.
• Partner with biostatisticians and biomarker experts to ensure high-quality data for analysis and internal decision-making.
• Ensure efficient implementation of key deliverables and provide frequent project status updates to cross-functional teams.

Qualifications

• Advanced scientific degree (Ph.D., Pharm.D., or MD) preferred, with minimum 5 years of relevant experience in biomarker and translational medicine strategies.
• Strong background in Oncology and Immunology with translational medicine experience.
• Proficiency in emerging diagnostic and predictive biomarker technologies is a plus.
• Innovative problem-solving skills for complex scientific challenges.
• Advanced communication skills for negotiation and stakeholder engagement.
• Proven track record in leading cross-functional teams and work streams (translational medicine, biostatistics, regulatory, pharmacology, clinical and immunogenicity assay development).
• Understanding of the Oncology development process, including study design, immunologic surrogates, assay development, and target product profile.

Skills

• Translational medicine strategy development
• Biomarker design and integration into development plans
• Cross-functional leadership and collaboration
• Data interpretation and decision-support for clinical programs
• Communication and stakeholder management

Education

• Ph.D., Pharm.D., or M.D. degree preferred (or equivalent).

Additional Requirements

• No explicit travel or physical demands are listed as essential in the provided content.