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Details

Clinical Development Director (Oncology)


Reference:KS/AIMR-272231 Location: Dublin
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed

Our client is a global Biopharma who are establishing a Clinical Trials Centre of Excellence in Dublin, Ireland. They are seeking a qualified Medical doctor (essential), preferably with Oncology clinical trial experience, in the area of Haematology or a related therapeutic area. The successful person shall lead multiple components of clinical trial programs in paediatric oncology clinical development. You may also act as the Physician Responsible on certain projects. For the assigned projects, you will be accountable for various aspects of ongoing clinical trial program-related activities. These activities include, but are not limited to, study protocol preparation, additional study or investigator documentation, contributions to data analysis plans, study reporting, and clinical development inputs into regulatory documentation, publications and scientific presentations.

Role/Responsibilities:

  • Provides input into or leads the development of the Target Product Profile and Clinical Development Plan for assigned molecules /products.
  • Provides scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelines.
  • Provides input into, or otherwise leads, paediatric study plans, clinical trial protocol design, clinical study reports and health authority inquiries.
  • Provides ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.
  • Manages the clinical development component(s) in the preparation/review of regulatory documents, investigator brochures and development plans.
  • Coordinates the collection and assimilation of ongoing data for internal analysis and review.
  • Coordinates and manages the preparation and/or review of data listings, summary tables, study results and scientific presentations.
  • Presents scientific information at scientific conferences as well as clinical study investigator meetings.
  • Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as SOPs.
Education/Experience:
  • Medical Doctor is essential qualification with 5+ years’ clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment.
  • Board certification in Oncology is preferred, including familiarity with paediatric oncology.
  • Experience in the biopharma industry is preferred.
  • Significant experience working with and leading cross-functional project/program teams in life sciences, healthcare, consulting or academia.
  • Experience taking the lead on study concept and protocol design, regulatory filings, clinical publications and presentations.
  • Demonstrated excellence in complex project management and effectively managing multiple clinical project deliverables and priorities through matrix management and leadership.
  • Proven analytical abilities as demonstrated through past experience and/or academic research.
  • Has core expertise in oncology or related disease area, as evidenced by ability to independently lead clinical development for deliverables for one or more projects.
  • Has thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials.
  • Strong communication and organizational skills. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives and steering committees.
  • When needed, ability to travel.
For further details please contact Karen Shiel on 087 745 2487 or send CV to [email protected]