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Details

Senior Director, Clinical Operations


Reference:KS/AKOY-246853 Location: Dublin
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed

Our client is a leading Biopharma who are establishing a Centre of Excellence in Dublin for their Global Development & Clinical Operations. The Senior Director, Clinical Operations will be a key member of the Dublin Leadership Team and will closely partner with Department Heads of each Therapeutic Area within the organization.

The successful candidate will be a valued member of therapeutic area leadership and life cycle management teams. In addition, he/she will provide clinical operational strategy and oversight of multiple compounds, indications, and programs to ensure clinical programs are conducted to meet project milestones with close attention to budget and quality in partnership with internal and external stakeholders. The Senior Director will also provide oversight and direction within the Clinical Operations department while mentoring and developing junior department members and project team partners.

Role/Responsibilities:

  • Provide leadership, functional expertise and oversight for the successful management of international clinical trials (Phase I - IV) across multiple indications through clinical study teams and through the use of CROs or internal resources
  • Resource management, such as employee new hire; retention activities; performance/rewards management; and succession planning
  • Provide strategic direction to and functional management of Clinical Operations
  • Manage subordinate directors and/or people managers
  • Lead and partner in the development and presentation of clinical operational strategy to executive leadership
  • Financial oversight of department, managing spend as planned and ensuring appropriate communication with clinical and corporate finance departments
  • Support development of SOPs within department and participate in the development of collaborative SOP development
  • Oversee and contribute to project team governance documents (clinical development plans, RFD, RF2, RF3)
  • Oversee and contribute to Clinical Study Reports, INDs, NDAs and other clinical/regulatory/safety documents
  • May function as executive sponsor for preferred vendor relationships
  • Collaborate cross-functionally on due-diligence efforts and assessments for mergers and acquisitions
  • Collaborate with regulatory, medical affairs and commercial to assist with life cycle management of approved drug products
  • Oversee and contribute to the development of abstracts, presentations and manuscripts
  • Initiate and oversee continuous efforts in reviewing and identifying best practices among study teams and enforcing standardization among teams
  • Support Gilead Public Relations and external corporate giving, or Employee Resource Group (ERG) initiatives (e.g. community service)


Education/Experience:

  • Bachelors Degree in a relevant scientific discipline OR Masters Degree in a non scientific discipline OR BSRN or BS + RN Certificate with extensive progressive and responsible clinical operations leadership experience
  • Ability to solve complex problems and use highly developed independent judgement relating to national and international regulations, guidelines, investigator interactions, and timelines
  • Demonstrated excellence in complex project management and the effective management of multiple projects/priorities
  • Proven ability to effectively communicate scientific, medical, and organizational concepts to internal and external customers
  • Ability to initiate and lead departmental or interdepartmental strategic initiatives
  • Proven ability to think critically and creatively, and to be able to work independently to determine appropriate resources for resolution of complex problems
  • Ability to effectively communicate
  • Ability to effectively use interpersonal skills, an ability to lead multifunctional teams, and to manage staff and mentor and develop junior staff
  • Demonstrated understanding of pharmaceutical regulatory requirements and impact on development of clinical trials
  • Ability to influence across a matrix and create a clear sense of direction
  • This position is located in Dublin, Ireland and may require international travel as required (valid travel documents must be obtainable)

  • Prior experience in the oversight and management of regulatory inspections (FDA, EMA, MHRA, PMDA, NMDA) in collaboration with Regulatory Compliance preferred
  • Pediatric clinical trials experience preferred


For further details please call Karen Shiel on 087 7452487 for a confidential discussion or send CV to karen.shiel@lifescience.ie