Moderna

Associate Director, Clinical Sciences - Oncology

Cambridge, Massachusetts, USA · Director · Contract

No sponsorship$159k-$286kDetected 28 days ago

Data AnalysisICD-10Clinical TrialsFDA RegulatoryPharmacovigilanceExperimental DesignCommunicationCollaborationBiostatisticsRegulatory Affairs

About the role

Assist in the development of the content for Investigator Meetings, investigator engagements and Advisory Board meetings.
Participate in continuous Improvement initiatives related to the clinical trial delivery operating model.

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.
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.
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.
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.

The individual must have the demonstrated ability to successfully work in a team environment.
A minimum of 8 years of clinical development experience within a pharmaceutical/biotechnology company.
Ability to travel up to 15% required for travel to work with study sites and attend national and international scientific congresses.

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.
Savings and investment opportunities to help you plan for the future
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.

A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
That's why our US benefits and global well-being resources are designed to support you-at work, at home, and everywhere in between.

thout 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, sexua

This listing is sourced directly from Moderna's careers page and normalized into a canonical job model.