Executive Director, Translational Medicine, Oncology

The Role:

Moderna is seeking an innovative, highly collaborative, strategic, and influential translational medicine leader for our innovative and expanding Oncology mRNA therapeutics pipeline.  In this role, you will guide and lead a team to develop robust plans to thoroughly understand mechanism of action, pharmacology, tissue localization/targeting, and patient population for promising experimental therapeutics, and inform mRNA platform learnings.  The ideal candidate will have an advanced degree(s), and pharmaceutical and/or significant biotechnology experience developing drug candidates in the clinic, and experience developing oncology drugs.  Experience in the development and submission of documents to health authorities and response to health authority inquiries a plus.  This important leadership role will partner with a talented and highly cross functional matrix team comprised of program leaders, medical directors, nonclinical and DMPK scientists, discovery research scientists, regulatory, clinical operations, clinical pharmacology and pharmacometrics, program management, and clinical biomarker assay partners to develop and execute the translational strategy to ensure and accelerate robust and successful clinical development, inform go/no go decision making, successful health authority filings, program differentiation, scientific publications, post-marketing and lifecycle support as needed.  The candidate will be a highly effective internal and external team player, communicator, and collaborator.

The ideal candidate will be a scientific innovator, problem solver, exceptional matrix and people leader, and thrive in our proactive mission driven, can-do culture that removes viscosity wherever possible to help advance our medicines with speed and rigor to patients with high unmet medical needs.  This position is ideally based in our Cambridge, MA headquarters.  Approximately 10% travel is expected in this role.

Here’s What You’ll Do:

• Develop and implement the translational medicine strategy for Oncology programs across the portfolio, including developing and communicating translational questions, hypotheses, recommendations regarding study design, endpoints (including novel endpoints), diagnostic strategy, safety evaluation, dose, pharmacology and PD biomarkers

• Develop, coach, and grow translational scientific leaders to increase their impact on our programs

• Serve as a strategic development partner for Program Team Leads to ensure efficient development and implementation of all key translational deliverables and provides frequent project status updates to the cross-functional development teams

• Work with key matrix partner functions to define our integrated development plans, including the assessment of unmet medical need, proposal of clinical development pathways, and interpretation of preclinical data to aid in clinical study design

• Work vertically across Research and Development to define the clinical translational strategy and delivery plan well in advance of IND submission to ensure future program readiness and success

• Develop and lead the reverse translation of our clinical studies to better enable research and development, as well as platform learnings

• Identify and work to validate novel endpoints for early go/no go decision making, accelerated approvals, and refine clinical study patient populations to support rapid demonstration of safety and efficacy and clinical proof of concept

• Provide translational leadership to early and late development project teams

• Work closely with scientists in research and with biomarker experts in development to align preclinical and clinical biomarker strategies to meet or exceed program needs

• Consult with external and internal subject matter experts to all major go/no-go development decision criteria to enable best decisions for the program.

• Partner with Clinical Biomarkers Lead(s) to define an implementable biomarker assay 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, computational, and biomarker experts to ensure delivery and interpretation of high-quality data to support internal decision-making and health authority filings

• Must be able to manage multiple projects and deliverables across R&D, including assessment of workload, prioritization, and resourcing requirements to deliver the program team’s objectives

• As a member of the translational medicine leadership team, shape the f