Sr. Director, Translational Medicine, Oncology – Moderna – Cambridge, MA

The Role:

Moderna is seeking a Head of Translational Medicine with advanced degree(s) and pharmaceutical experience to lead translational medicine across in Oncology. The role will work with a cross functional team (medical directors, nonclinical and discovery research scientists, regulatory, clinical operations) on biomarker and translational strategy for clinical development and regulatory approvals. Position is based in Cambridge, MA headquarters with remote working possible. There is approximately 10% travel expected as part of this role.

The successful candidate is able to work independently and thrive in a proactive can-do culture and will be an effective leader in a matrix organization. Deep scientific rigor, a thorough understanding of experimental medicine, drug development and genetics are key success factors. The candidate will be a highly-effective internal and external team player, communicator and collaborator.

Here’s What You’ll Do:

• Develop and implement the entire Oncology portfolio translational medicine strategy across the portfolio, including making recommendation regarding endpoints, study design, safety evaluations and dose selections.

• Work vertically across Research and Development to define the key early clinical translational steps in the development strategy

• Develop and lead reverse translational strategy to enable research and development

• Lead a group of scientists and physicians that will work to support programs directly

• Work 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.

• 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

• Provide clinical leadership to early development project teams, including serving as key representative for clinical development/medical strategy areas both internal and external facing (e.g., CRO, KEE, Data monitoring Committees and clinical trial site staff)

• Work closely with scientists in research and with biomarker experts in clinical development to align preclinical and clinical biomarker strategies

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

• 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

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

• 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 Bring to the Table:

• Advanced scientific degree (M.D., Ph.D., Pharm.D.), with minimum 8 years of relevant work experience developing biomarkers, including a minimum of 5+ years in a leadership role developing translational medicine strategies.

• A strong background in Oncology and experience in translational medicine

• Thorough understanding of genetics, immune-oncology and experimental design

• Proficiency in emerging diagnostic and predictive biomarker technologies

• Outstanding verbal and written communication skills, and excellent organizational skills

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

• Experience in leading development of companion and complementary diagnostics

• Thorough command of ICH and GCP guidelines to ensure the appropriate ethical conduct of clinical studies in the United States, Europe and rest of world.

• Experience in regulatory cGCP inspections and audits.

• 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.

Here’s What We’ll Bring to the Table:

• On-site subsidized cafeteria or catered lunches
• Company-provided iPhone
• Free parking, monthly subway pass or a subsidized commuter rail pass
• Free annual corporate membership to Bluebikes
• Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
• Flexible Spending Accounts for medical expenses and dependent care expenses
• 16 weeks of 100% paid parental leave for all new parents
• 16 weeks 100% paid family caregiver leave
• 20 weeks 100% paid medical leave
• Eligible for “Moderna Month” (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)
• Adoption assistance and discounts to local childcare centers, as well as access to care.com
• 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
• A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
• Voluntary legal assistance plan
• 15 days’ vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)

About Moderna:

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.

Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com .

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.