Moderna

Moderna

Executive Director, Clinical Development, Oncology

Cambridge, Massachusetts, USA · Director · Contract

Sponsorship not specified$243k-$437kDetected 28 days ago
GCPRESTMachine LearningStatisticsBusiness DevelopmentClinical TrialsClinical ResearchPharmacologyFDA RegulatoryResearchExperimental DesignLeadershipCommunicationCollaborationProblem SolvingMentoringPublic SpeakingBiostatistics

About the role

  • Establish expeditious clinical development timelines, incorporating key decision points and Go/No Go criteria for the CDP.
  • Play an active role in the technical and leadership development of Clinical Sciences staff through coaching and mentoring, with potential direct line management.
  • Scientific Leadership, Direction and Strategy

Responsibilities

  • Provide integrated and innovative clinical development strategy to support the creation and management of the Clinical Development Plan (CDP) for assets in development.
  • Develop and maintain relationships with program counterparts in Commercial, Research, Regulatory, Clinical Operations and Statistics.
  • Study & Program Design and Evidence Generation
  • Drive the end to end integrated clinical development strategy that is appropriately resourced to achieve regulatory approvals, reimbursable medicines, and successful lifecycle management.
  • Champion implementation of innovative methods and processes within clinical development and gain stakeholder support; encourage others to think differently and come up with business solutions.
  • Experience in immuno-oncology or oncology clinical drug development, as well as significant knowledge and experience leading the design and execution of clinical trials.
  • Integrate scientific rationale, regulatory requirements, product development plan and commercial goals to optimize clinical study designs aligned with the Integrated Development Plan (IDP) and CDP.
  • Contribute to and partner on the development of strategic initiatives, specific Business Development activities and various organizational initiatives in Clinical Development.
  • Lead selected clinical development projects for products/franchise of compounds.
  • Lead clinical development discussions at regulatory interactions and clinical components of the submissions (e.g. IND, BLA, MAA) including briefing documents, presentations, addressing questions and responses.

Requirements

  • Generate the data and evidence required to determine a medicine's potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe.

Skills

  • Overcome obstacles by experimenting with and adopting new ways of working including digital tools and technology.

Compensation

  • The salary range for this role is $243,100.00 - $437,000.00.

Benefits

  • Accountable for risk/benefit of the asset.
  • Actively lead and make decisions that balance risk/benefit at the project level with clear understanding of impact on study/project indication approvals; take action to mitigate risk where appropriate.
  • Assess and predict when therapies designed for one patient population/indication can be used in alternative scenarios to broaden potential patient benefit.
  • Deliver value and access insights to inform medical strategy, expand market access and to address unmet patient need.

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.