Oncology Clinical Sciences: Associate Director, Study Leadership

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

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.