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Details

Senior Director, Clinical Research


Reference:KS/ATHI-648072 Location: Dublin
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Director of Clinical Research

Senior Director, Clinical Research

Our client is a global Biopharma with leading therapies in infectious diseases & oncology in particular. They are establishing a Centre of Excellence in Dublin for their global Paediatric Trials. The Sr Director MD, Clinical Research, position will design, conduct, and evaluate Phase 1, 2, and 3 clinical trials and provide scientific expertise on paediatric viral infectious diseases. They are seeking a qualified Medical doctor with extensive clinical trials experience gained in industry. Infectious diesase & paediatrics experience a distinct advantage.

Essential Functions:

  • Interfaces with staff to share scientific and clinical information and consistent practices.
  • Leads/supports protocol review discussions concerning scientific and procedural aspects of study design.
  • Serves as resource for junior staff.
  • Oversees the scientific aspects of clinical studies throughout duration of study.
  • Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as our clients SOPs.
  • Prepares study protocols, amendments, specific sections of study manuals and Investigator meeting notebooks, and other documents as needed.
  • Supervises or assists other CR staff with preparation of above. Contributes to the design and development of CRFs, Data Management Manuals and Data Analysis Plans.
  • Helps ensure consistency across protocols.
  • Presents scientific information as needed.
  • Addresses questions regarding scientific and related procedural issues from Investigators.
  • Coordinates and implements ongoing data for internal analysis and review.
  • Coordinates/supports the preparation/review of regulatory documents, PIPs/PSPs, safety reports, Investigator Brochures, and NDAs.
  • Determines the functions most critical to company success and supports priorities within functional area.
  • Anticipates fairly complex obstacles and implements solutions that meet goals.
  • Creates effective teams with a clear sense of direction.
  • May lead two or more specific components of departmental strategic initiatives.


Education/Experience:

Essential:

  • A higher degree Medical Doctor, with significant years in clinical research or clinical pharmacology in a pharmaceutical company, contract research organization or academic institution
  • Experience in paediatric medicine and/or paediatric drug development will be highly desirable but not required
  • Excellent verbal and written communication skills and interpersonal skills are required to maintain working relationship with team members to ensure scientific integrity of clinical studies.
  • Examines functional issues from a broader organization perspective.
  • Knowledge of clinical trial design to develop specific study concept sheets and protocols is required.

Desirable Skills:

  • Familiarity with virology and HIV medicine preferred
  • Clinical or translational research experience preferred
  • Pharmaceutical/Biotech industry experience in clinical development preferred
  • Successful leadership and management experience
  • Excellent organizational and communication skills are critical


For further details please contact Karen Shiel in confidence on 087 7452487 or send CV to karen.shiel@lifescience.ie