Senior Oncology Clinical Trials Lead - Data & Study Delivery

BioSpace; Cambridge (MA); On-site; USD 159,000 - 286,000; Full time

Benefits offered by this job

Healthcare benefits

Well-being programs

Paid time off

Family planning support

Discretionary bonus potential

Job summary

Moderna seeks a pharmacovigilance-leaning clinical development professional to support Oncology Therapeutic programs, assisting the Clinical Study Lead in developing, executing, and evaluating Phase 1-3 studies with a focus on data quality for regulatory submissions.

Responsibilities include end-to-end trial delivery, data review, site management, safety collaboration, and authoring core regulatory documents, with in-office 70% at Cambridge, MA or Princeton, NJ and travel up to 15%.

Qualifications

• Ability to work in a team environment.
• PhD/PharmD/Masters or advanced nursing with oncology knowledge and drug development experience.
• A minimum of 8 years of clinical development experience.
• Significant experience with ensuring clinical trial data integrity, data analysis, including exploratory analyses, and data presentation; familiarity with Medidata Rave and analytics platforms (e.g. Elluminate, Spotfire).
• Excellent written and oral communication and presentation skills.
• Ability to travel up to 15% for travel to study sites and scientific congresses.
• Role based in Cambridge, MA or Princeton, NJ with in-office 70% of the time and up to 30% remote.

Responsibilities

• Oversee end-to-end delivery of clinical trial protocols including study design, initiation, medical safety data monitoring, data dissemination and closeout activities.
• Participate in start-up of global clinical studies to ensure on-schedule site activation and subject enrollment; design study parameters to minimize risk and improve site performance; contribute to inspections readiness activities.
• Perform and coordinate clinical data review and analysis of study data, including CRFs, data listings, medical coding and patient profiles to verify data.
• Collaborate with the Clinical Study Lead in overseeing studies; review and interpret data and ensure timely deliverables with the team and external partners.
• Support study site management with safety decisions in alignment with the protocol alongside Safety & Pharmacovigilance.
• Assist in developing content for Investigator Meetings and Advisory Boards.
• Author/review clinical study documents (protocols, informed consent, DSURs, Investigator Brochures, INDs) per regulatory standards.
• Support evolution of the clinical science role and participate in continuous improvement initiatives for the trial delivery model.

Job description

Moderna seeks a pharmacovigilance-leaning clinical development professional to support Oncology Therapeutic programs, assisting the Clinical Study Lead in developing, executing, and evaluating Phase 1-3 studies with a focus on data quality for regulatory submissions.

Responsibilities include end-to-end trial delivery, data review, site management, safety collaboration, and authoring core regulatory documents, with in-office 70% at Cambridge, MA or Princeton, NJ and travel up to 15%.