The role will support Oncology Therapeutic programs, specifically supporting the Clinical Development Lead in the direction, execution and evaluation of Phase 1-3 clinical studies. The principal responsibility for this role is ensuring the comprehensive data quality of clinical studies to support internal governance decisions and support regulatory submissions.
Here’s What You’ll DoIn conjunction with the Clinical Development Lead and the broader clinical development team, contribute to regulatory and clinical program strategy, clinical trial design and clinical study execution. Author and review clinical study documents in compliance with regulatory standards, including: clinical protocols, informed consent documents, Development Safety Update Reports (DSUR) and clinical components of Investigator Brochures, INDs and marketing applications. Collaborate with the Clinical Development Lead in the oversight of clinical studies. May lead a clinical study with oversight from the Clinical Development Lead to provide clinical study leadership, review and interpretation of clinical data, and ensure timely execution of deliverables in collaboration with internal and external partners. Perform and coordinate clinical data review and analysis of study data, including review of case report forms, data listings, medical coding and patient profiles to ensure the proper and complete verification of clinical data. In collaboration with the Clinical Development Lead and Clinical Safety & Pharmacovigilance, support managing study sites to ensure that study treatment discontinuation or other safety decisions are made in alignment with the protocol. Collaborating with Clinical Operations, participate in the start-up and execution of global clinical studies to ensure on-schedule site activation and subject enrollment of a clinical trial. Design and implement clinical study parameters to minimize operational risk and increase study site performance and efficiency. Collaborate on and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct. Develop the strategy and drive the messaging and associated content for Investigator Meetings, investigator engagement and Advisory Board meetings. Responsibility for training and educating junior Clinical Science personnel. Support and help drive the evolution of the clinical science role at Moderna and support process updates. Participate in Development workstreams related to the clinical trial delivery operating model.
Here’s What You’ll Need A personal and professional commitment to the highest personal and ethical standards. A high-performing, self-motivated and energetic individual who demonstrates outstanding scientific and clinical oncology knowledge that results in the conduct of well-executed clinical research. A history of successfully operating in a matrix environment and the demonstration of highly developed interpersonal and communication skills. Capability to successfully contribute to both early and late-stage clinical development programs. This will involve close with Drug Discovery, Translational Medicine, Regulatory Affairs, Biostatistics, Medical Affairs and Commercial.
Here’s What You’ll Bring to the TableThe individual must have the demonstrated ability to successfully work in a team environment. This role is best suited for candidates holding a PhD, PharmD, Masters’ or advanced nursing degree with significant scientific and clinical oncology knowledge, pharmaceutical/biotechnology company experience and a comprehensive knowledge of drug development. A minimum of 10 years of clinical development experience within a pharmaceutical/biotechnology company. Significant experience with clinical study design and protocol development. Significant experience with ensuring data integrity, data analysis and data presentation. Excellent written communication, oral communication, and presentation skills. Ability to travel up to 15% required for travel to work with study sites and attend national and international scientific congresses. This role is based in our new LEED-certified HQ in Cambridge, MA, or Princeton, NJ office and is expected to be in-office 70% of the time with flexibility to work from home up to 30%.
Pay & Benefits:
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.
Competitive healthcare, plus voluntary benefit programs to support your unique needs
A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
Family planning benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investments to help you plan for the future
Location-specific perks and extras
The salary range for this role is $183,800.00 - $330,300.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.
About ModernaSince 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.
Our Working ModelAs 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.
Equal OpportunitiesModerna 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.
Moderna is an E-Verify Employer in the United States.
We consider qualified applicants regardless of criminal histories, consistent with legal requirements.
AccommodationsWe’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.
Export Control NoticeThis 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.
Our Mission and VisionAt Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today.
Third Party Staffing AgenciesModerna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specific position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes.
Reasonable Accommodation NoticeReasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. It should be noted that the company may provide accommodations to support diverse employee needs.
