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Karen Shiel
Life Science

+353 1 5079256
[email protected]
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Details

Director, Clinical Development (Oncology)


Reference:KS/ANXO-071174 Location: South East
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Account Director, Clinical Project Manager, Clinical Research Associate, Clinical Trials Advisor, Doctor (Medical)

Our client is a Global Biopharma who has been a leading innovator in the field of virology, having developed many of today’s leading medicines for treating and preventing HIV and viral hepatitis. More recently, they have expanded its oncology portfolio, and seeks to become a leader in this critical disease area.

In this role as Director, Clinical Development, you will lead regional components of clinical trial programs in Oncology clinical development. For the assigned projects, you are accountable for various aspects of regional 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. Reporting to the SVP, Clinical Development Oncology, this role is based at their European Headquarters in the UK.

Role/Responsibilities:

  • Provides input into or leads the regional 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 regional clinical development project deliverables and timelines.
  • Provides input into, or otherwise leads, 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 our clients’ SOPs.
Education & Experience:
  • Essential - PharmD, PhD or MSC degree in clinical research or clinical pharmacology with significant scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment is required.
  • Highly desirable - MD with board certification in Oncology, including familiarity with clinical oncology medicine.
  • Extensive experience working on, 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 the Oncology 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.
  • Effective 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]