Associate Director, Clinical Sciences, Oncology

Moderna Therapeutics; Cambridge (MA); Hybrid; USD 159,000 - 286,000; Full time

Benefits offered by this job

Healthcare coverage

Well-being resources

Paid time off

Bonus potential

Equity options

Job summary

Moderna Therapeutics in Cambridge, MA (HQ) or Princeton, NJ is seeking an experienced clinical data professional to support Oncology programs. You will collaborate with Clinical Operations to start up global studies, ensure data quality, and support regulatory submissions across Phase 1–3.

The role emphasizes data integrity, analytics, and cross-functional teamwork, with 70% in-office and up to 30% remote. Travel up to 15% is required.

Qualifications

• Must be able to work effectively in a team environment.
• PhD/PharmD/Master's or advanced nursing degree with oncology and drug development experience.
• Minimum of 8 years in clinical development within pharma/biotech.
• Significant experience ensuring trial data integrity and analysis.
• Experience with Medidata Rave and analytics platforms (Elluminate, Spotfire) preferred.
• Excellent written and oral communication and presentation skills.
• Travel up to 15% for site visits and congresses.
• Role based in Cambridge, MA or Princeton, NJ with 70% in-office and 30% remote.

Responsibilities

• Collaborate with Clinical Operations to start up global studies and activate sites on schedule.
• Design study parameters to minimize risk and boost site performance.
• Contribute to inspection readiness for audits and inspections.
• Review and analyze study data, including CRFs, data listings, and codes.
• Support oversight of clinical studies with the Study Lead.
• Interpret data and ensure timely deliverables with Clinical Trial Team and partners.
• Support safety decisions aligned with protocol with Clinical Safety & Pharmacovigilance.
• Develop content for Investigator Meetings and Advisory Board engagements.
• Author/review documents (protocols, ICFs, DSURs, ICs) per regulatory standards.
• Drive evolution of the clinical science role and process improvements.
• Participate in continuous improvement of the trial delivery model.

Skills

Team collaboration

Clinical data analysis

Data integrity

Regulatory submissions

Data presentation

Travel up to 15%

Education

PhD

PharmD

Master's degree

Advanced nursing degree

Tools

Medidata Rave

Elluminate

Spotfire

Job description

The Role

This role will support Oncology Therapeutic programs, specifically supporting the Clinical Study Lead in the development, execution and evaluation of Phase 1-3 clinical studies. The principal responsibility for this role is to ensure the comprehensive data quality of clinical studies to support both internal governance decisions and regulatory submissions.

Here’s What You’ll Do

• Collaborating with Clinical Operations, participate in the start-up 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.


• 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.


• Collaborate with the Clinical Study Lead in the oversight of clinical studies.


• Provide review and interpretation of clinical data and ensure timely execution of deliverables in collaboration with both the Clinical Trial Team and external partners.


• In collaboration with the Clinical Study 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.


• Assist in the development of the content for Investigator Meetings, investigator engagements and Advisory Board meetings.


• 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.


• Support and help drive the evolution of the clinical science role at Moderna and support process improvements.


• Participate in continuous Improvement initiatives related to the clinical trial delivery operating model.

Here’s What You’ll Need (Basic Qualifications)

• The 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 substantial knowledge of drug development.


• A minimum of 8 years of clinical development experience within a pharmaceutical/biotechnology company.


• Significant experience with ensuring clinical trial data integrity, data analysis, including exploratory analyses, and data presentation.


• Experience with Medidata Rave and clinical data analytics platforms (e.g. Elluminate, Spotfire) is preferred.


• 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%.

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• 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.


• A personal and professional commitment to the highest personal and ethical standards.


• Capability to successfully contribute to both early and late-stage clinical development programs. This will involve close collaboration with Drug Discovery, Translational Medicine, Regulatory Affairs, Biostatistics, Medical Affairs and Commercial.

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 $158,600.00 - $285,500.00. 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 Moderna

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.

Our Working Model

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

Equal Opportunities

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. Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Accommodations

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 [e-mail].

Please inform the company's personnel representative by calling 617-460-9346 or emailing [e-mail] if you need assistance completing any forms or to otherwise participate in the application process.

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.

Third Party Staffing Agencies

Moderna 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 specified 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.

Our Mission and Vision

At 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.