- Work across Research and Development to define translational medicine strategy across oncology portfolio, including making recommendation regarding endpoints, study design, safety evaluations and dose selections.
- 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 enable 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.
- Advanced scientific degree in a relevant scientific field (M.D., Ph.D., Pharm.D.), 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, pre-clinical 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.
- 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
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Associate Director, Oncology, Translational Medicine - Cambridge, United States - Moderna, Inc.
Description
The Role:Moderna is seeking a Translational Medicine Expert 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) on the translational strategy for clinical development and regulatory approvals. Position is ideally based in Cambridge, MA headquarters.
Here's What You'll Do:
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at (EEO/AAP Employer)
