Job Description

Senior Director of Clinical Research- Dublin

Ref No: SF17282

Co. Dublin, Ireland

Competitive salary

Senior Director of Clinical Research- Dublin

Core Purpose:

A multinational Bopharmaceutical Manufacturer based in Dublin are recruiting A Senior Director In Clinical Research. The Sr Director MD, Clinical Research, position will design, conduct, and evaluate Phase 1, 2, and 3 clinical trials and provide scientific expertise on pediatric viral infectious diseases.

Core Responsibilities:

  • 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 Gilead 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 if 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.

Qualifications & Experience 

  • Typically requires a higher degree Medical Degree based
  • A significant number of years (5+) in clinical research or clinical pharmacology in a pharmaceutical company, contract research organization or academic institution
  • Experience in pediatric medicine and/or pediatric 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 & Experience:

  • 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

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