Director, Translational Medicine - Oncology

The Role:

Moderna is seeking a Translational Medicine Expert with advanced degree(s) and pharmaceutical experience. This Translational Medicine role 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) on the translational strategy for clinical development and regulatory approvals. Position is ideally based in Cambridge, MA headquarters. There is approximately 10% travel expected as part of this role.

The successful candidate can work independently and thrive in a proactive can-do culture and will be an effective contributor 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.

Heres What Youll 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

• 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 a key representative for clinical development 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 teams 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

Heres What Youll Bring to the Table:

• Advanced scientific degree (M.D., Ph.D., Pharm.D.), with minimum 5 years of relevant work experience developing biomarkers, including a minimum of 3+ years in a 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.

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  Vacation, sick time and holidays
  Volunteer time to participate within your community
  Discretionary year-end shutdown
  Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.

About Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. 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 and approval 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 autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven 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 persons 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.

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