Moderna

Moderna

Director, Clinical Sciences, Oncology

Cambridge, Massachusetts, USA · Director · Contract

No sponsorship$184k-$330kDetected 15 days ago
Data AnalysisICD-10Clinical TrialsFDA RegulatoryPharmacovigilanceExperimental DesignLeadershipCommunicationCollaborationBiostatisticsRegulatory Affairs

About the role

  • 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.
  • Responsibility for training and educating junior Clinical Science personnel.
  • Participate in Development workstreams related to the clinical trial delivery operating model.

Responsibilities

  • In 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.
  • 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.
  • 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.
  • 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.
  • This 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.
  • Collaborate with the Clinical Development Lead in the oversight of clinical studies.

Requirements

  • The individual must have the demonstrated ability to successfully work in a team environment.
  • 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.
  • Ability to travel up to 15% required for travel to work with study sites and attend national and international scientific congresses.

Skills

  • Excellent written communication, oral communication, and presentation skills.

Compensation

  • The salary range for this role is $183,800.00 - $330,300.00.

Benefits

  • 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
  • That's why our benefits and well-being resources are designed to support you-at work, at home, and everywhere in between.
  • Location-specific perks and extras

Visa & Work Authorization

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