Cambridge, Massachusetts, United States · Hybrid
$167k–$301k/yr
The Role Moderna is seeking an individual to lead development and execution of global regulatory strategy for programs in its oncology portfolio. This leader will shape regulatory pathways for novel, first-in-class thera…
Skills: Regulatory strategy, Oncology, FDA regulations, EU regulations, ICH guidelines
Cambridge, Massachusetts, United States · On-site
$100k–$275k/yr
Overview: Draper is an independent, nonprofit research and development company headquartered in Cambridge, MA. The 2,000+ employees of Draper tackle important national challenges with a promise of delivering successful a…
Skills: Information System Security Management, Risk Management Framework, Cyber defense, Vulnerability compliance, Security architecture
Cambridge, Massachusetts, United States · On-site
$180k–$340k/yr
Overview: Draper is an independent, nonprofit research and development company headquartered in Cambridge, MA. The 2,000+ employees of Draper tackle important national challenges with a promise of delivering successful a…
Skills: Cyber operations, IT infrastructure management, Budget management, Strategic planning, Cloud solutions
Cambridge, Massachusetts, United States · On-site
$2k–$3k/wk
Overview Registered Nurse – Postpartum in Cambridge, MA, United States. This is a 13-week travel assignment starting 09/15/2026 in a hospital setting. Weekly pay ranges from $2,460 to $2,589 per week with guaranteed hour…
Skills: Postpartum care, Newborn care, Vital signs monitoring, Medication administration, IV therapy
Cambridge, Massachusetts, United States · On-site
$146k–$234k/yr
Cambridge, US; Gaithersburg, US; New Jersey, US | full time | Job ID: 11654 About the Role: At BioNTech, we are committed to revolutionizing medicine through cutting-edge science and innovation. As Associate Director, Cl…
Skills: Clinical pharmacology, Pharmacometrics, Pharmacokinetics, Pharmacodynamics, Drug development
Cambridge, Massachusetts, United States · Hybrid
$153k–$283k/yr
Job Description Summary #LI-Onsite Location: Cambridge, MA, USA Relocation Support: Yes Imagine advancing biomarker science that helps transform promising discoveries into life-changing medicines. As a Sr Principal Scien…
Skills: Biomarker assay development, Translational research, Scientific leadership, Strategic thinking, Team mentorship
Cambridge, Massachusetts, United States · Hybrid
$126k–$234k/yr
Job Description Summary Location: Cambridge or Basel Onsite Relocation is offered for this role. #LI-Onsite The Oncology Data Science team in Biomedical Research at Novartis works at the intersection of oncology drug dis…
Skills: Artificial Intelligence, Deep Learning, Digital Pathology, Machine Learning, Computational Biology
Cambridge, Massachusetts, United States · On-site
$150k–$320k/yr
Overview: Draper is an independent, nonprofit research and development company headquartered in Cambridge, MA. The 2,000+ employees of Draper tackle important national challenges with a promise of delivering successful a…
Skills: Cyber monitoring, Threat detection, Incident response, Vulnerability management, Security operations center leadership
Cambridge, Massachusetts, United States · On-site
$32/hr–$55/hr
When you join the growing BILH team, you're not just taking a job, you’re making a difference in people’s lives. REGISTERED NURSE,MPS Job Description: Principal Duties and Responsibilities 1. Act in compliance with nursi…
Skills: Nursing process, Clinical expertise, Patient triage, Phlebotomy, Patient care
Cambridge, Massachusetts, United States · On-site
$100k–$275k/yr
Overview: Draper is an independent, nonprofit research and development company headquartered in Cambridge, MA. The 2,000+ employees of Draper tackle important national challenges with a promise of delivering successful a…
Skills: Cybersecurity, Artificial Intelligence, Machine Learning, Large Language Models, Python
Cambridge, Massachusetts, United States · Hybrid
$139k–$257k/yr
Band Level 4 Job Description Summary #LI-Hybrid Location: Cambridge, United States or Basel, Switzerland (see separate posting) Relocation Support: This role is based in Cambridge, United States. Novartis is unable to of…
Skills: Patent searching, Scientific literature research, Patent analytics, Intellectual property research, Technical research
Cambridge, Massachusetts, United States · Hybrid
$100k–$150k/yr
Senior Services Consultant As a Senior Services Consultant, you will be responsible for guiding prospects and customers through the process of determining the right implementation and service strategy to support both the…
Skills: Consultative approach, SaaS implementation, CRM, ERP, Project management
Cambridge, Massachusetts, United States · On-site
$192k–$256k/yr
Your Impact at LILA Join us in shaping the future of science! We are seeking Staff Software Engineers with backend experience to join our Lab Software Team (LaS), where you’ll collaborate with software engineers, lab sci…
Skills: Backend development, Python, React, TypeScript, FastAPI
Cambridge, Massachusetts, United States · On-site
$108k–$140k/yr
Your Impact at LILA Lila Sciences is hiring a Software Engineer to develop the next generation of Lab Instrument Integration Software, which is a foundational component of our AI-enabled laboratory. We are looking for se…
Skills: Python, C#, .NET, Hardware-software integration, Debugging
Cambridge, Massachusetts, United States · On-site
$180k–$256k/yr
Your Impact at LILA We are a cross-functional team (Software and Robotics) developing orchestration algorithms (instrument scheduling and robot routing) and lab simulation capabilities. We are building the muscles of the…
Skills: Operations research, Backend development, Data pipelines, API design, Kubernetes
Cambridge, Massachusetts, United States · On-site
$144k–$240k/yr
Your Impact at LILA You will steward Verification & Validation and software quality for our autonomous labs, where software meets real robotics hardware. On the Independent Verification & Validation team, you'll build th…
Skills: Python, Pytest, Playwright, CI/CD, GitHub Actions
Cambridge, Massachusetts, United States · On-site
$120k–$192k/yr
Your Impact at LILA Lila Sciences is building autonomous science platforms that compress the cycle time of scientific discovery. The Robotics and Scheduling teams develop the scheduling and coordination infrastructure th…
Skills: Simulation engineering, Operations research, Software engineering, API design, CI/CD
Cambridge, Massachusetts, United States · On-site
$192k–$238k/yr
Your Impact at LILA You will be the program owner for Physical AI — the shared infrastructure our autonomous labs run on. Working across multiple engineering teams, you'll turn the platform roadmap into a sequenced, depe…
Skills: Technical program management, Infrastructure software, Dependency management, Risk management, Reliability engineering
Cambridge, Massachusetts, United States · On-site
Company Description By working at Harvard University, you join a vibrant community that advances Harvard's world-changing mission in meaningful ways, inspires innovation and collaboration, and builds skills and expertise…
Skills: Operations management, Staff leadership, Performance management, Customer service, Budgeting
Cambridge, Massachusetts, United States · On-site
$37/hr–$37/hr
Join Our AoPS Academy as a Language Arts Instructor! Are you passionate about language arts? Do you love inspiring young minds in an engaging, collaborative classroom setting? We have the perfect opportunity for you! We …
Skills: Language Arts Instruction, Classroom Management, Curriculum Implementation, Student Engagement, Grading And Feedback
Cambridge, Massachusetts, United States • Hybrid
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
The Director will serve as the global regulatory lead for assigned programs, developing and executing regulatory strategies while representing Regulatory Science on cross-functional teams. They are responsible for managing submissions to health agencies, monitoring regulatory developments, and negotiating directly with regulatory authorities to ensure program success.
Candidates must hold a BA/BS degree in a scientific or engineering discipline with at least 10 years of pharmaceutical industry experience, including 8+ years in regulatory strategy. Expert knowledge of FDA, EU, and ICH guidelines for oncology programs is required, along with a proven track record in securing product approvals.
Moderna is seeking an individual to lead development and execution of global regulatory strategy for programs in its oncology portfolio. This leader will shape regulatory pathways for novel, first-in-class therapeutics and drive successful global development and registration strategies.
This role requires a seasoned regulatory leader who embodies Moderna’s leadership principles: acting with urgency, challenging convention, delivering with excellence, and operating as an enterprise leader. The individual will demonstrate executive presence, deep functional expertise, and a strong execution track record while elevating strategic impact across programs.
Lead global regulatory strategies from early development through commercialization
Drive regulatory submissions (INDs, CTAs, BLAs/MAAs) with excellence and urgency
Lead health authority interactions (FDA, EMA, PMDA), including high-stakes negotiations
Shape strategies for novel and first-in-class therapies
Partner cross-functionally and across alliances to align on strategy
Anticipate regulatory risks and proactively mitigate them
Build and develop high-performing regulatory teams
BA/BS degree in a scientific/engineering discipline
12+ years of experience in the Pharmaceutical industry
8+ years of experience in Regulatory strategy, including oncology
Strong knowledge of current US and EU regulations, including specifically: e.g. novel regulatory pathways.
Strong experience with CTD format and content regulatory filing
Exceptional written and oral communication
Experience with developing and implementing competitive regulatory strategies
Demonstrated track record in securing product approvals and maintaining a complex portfolio
Experience dealing with broad range of stakeholders at all levels internal and external to the company
Demonstrated competence in employee management and development
Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance – preferably from at least both US and EU
Direct experience of leading regulatory authority meetings in different phases of drug development
Graduate degree in a scientific discipline or other relevant graduate discipline or professional certification
Delivery of at least one major application (NDA/BLA/MAA/JNDA etc.)
Acts with urgency and delivers results with excellence
Thinks and operates as an enterprise leader
Challenges convention and drives innovation
Makes high-quality decisions under ambiguity and pressure
Builds and develops high-performing, accountable teams
Influences effectively across internal and external stakeholders
At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.
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.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
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.
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, 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 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 an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.
We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can 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 leavesandaccommodations@modernatx.com.
Export Control Notice
This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.
#LI-NH1-
Our mission is to deliver the greatest possible impact to people through mRNA medicines.
Moderna is a pioneer and leader in the field of mRNA medicine. Through the advancement of its technology platform, Moderna is reimagining how medicines are made to transform how we treat and prevent diseases. Since its founding, Moderna's mRNA platform has enabled the development of vaccines and therapeutics across infectious diseases, cancer, rare diseases and more. With a global team and a unique culture, driven by the company's values and mindsets, Moderna's mission is to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X, Facebook, Instagram, YouTube and LinkedIn. This Moderna page is not the appropriate place to report adverse events (side-effects) for any products. If you are or someone you know is experiencing a side effect, please reach out to your healthcare professional. Moderna is continuously monitoring the safety of its products. We encourage you to report any side effects directly to us at 1‑866‑MODERNA (1‑866‑663‑3762). Please be cautious of fraudulent recruitment offers claiming to be from Moderna. Recruitment scams of this sort may originate from fake websites, social media accounts, or unsolicited communications and may ask you for personal information or request you pay them or someone else. Moderna will never ask you for payment, banking information, or anything of this sort at any stage of the recruitment process. If you are unsure about a communication, do not provide personal information and report the activity to [email protected]. You may also report suspected fraud to the FBI’s Internet Crime Complaint Center (IC3).
Offices: 200 Technology Sq, Cambridge, Massachusetts 02139, US · 1 Upland Rd, Norwood, Massachusetts 02062, US
