Expert Clinical Program Manager

1 day ago

Dublin, Dublin City, Ireland beBeeClinical Full time €180,000 - €231,000
Clinical Development Director Role Overview

The Clinical Development Director leads the strategic planning and end-to-end management of assigned clinical programs. As CDD for the Renal therapeutic area, oversight of clinical development for assigned programs will drive execution of the clinical development plan.

Enabling an empowered organization to navigate a matrix environment and adjust quickly to business needs is essential.

Key responsibilities include:

  • Providing clinical leadership and strategic input for all clinical deliverables in assigned projects or sections of clinical programs.
  • Leading development of clinical sections of trial and program-level regulatory documents.
  • Driving execution of the section of the clinical program in partnership with global line functions, Global Trial Directors, and regional/country medical associates.
  • Overseeing and conducting ongoing medical and scientific review of clinical trial data with Clinical Scientific Experts.
  • Supporting overall safety of molecules for assigned sections and may be a core member of the Safety Management Team.
  • As a clinical expert, supporting interactions with external and internal stakeholders and decision boards.
  • Contributing to scientific training of relevant stakeholders on disease areas and compounds/molecules.

Required skills and qualifications:

  • Advanced degree in life sciences/healthcare or clinically relevant degree.
  • Fluent oral and written English.
  • Minimum 7 years experience in clinical research or drug development.
  • Working knowledge of assigned disease areas with proven ability to interpret, discuss, and present efficacy and safety data.
  • Demonstrated ability to establish effective working relationships with key investigators.
  • Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes.
  • Strong communication skills with ability to work in a cross-functional and global organization.

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