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Sinead Cullen
Life Science

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Details

Associate Director Clinical Development


Reference:SCA013962 Location: Cork
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Clinical Project Manager, Clinical Research Associate, Clinical Research Nurse, Clinical Trials Advisor

Associate Director Clinical Development
Our client, a global pharma company, are continuing to add talented clinical professionals to their Clinical Development team, and are currently recruiting for an Associate Director to join their team on a permanent basis. You will have experience working in Clinical Trials/Clinical Research/Clinical Operations/Clinical Development and be an experienced people manager/team lead. This role is hybrid working, however, if you are living outside of the Republic of Ireland, relocation to Ireland is essential.

Responsibilities:

  • Partner with functional, cross-functional and team leadership to provide operational input into the feasibility and resource requirements associated with clinical plans
  • Provide strategic direction and leadership to CTPMs to enable them to drive the implementation of the Regional/Global enrollment strategy, to accomplish milestones to plan. Escalates related issues to appropriate parties for awareness and resolution
  • Collaborates with Medical Sourcing, Procurement, CPM, and compound Team Management to provide and enable decisions related to internal/external-sourcing options
  • Work closely with the clinical project manager to ensure planning databases are accurate and up-to-date
  • Work to align resources based upon team prioritization decisions and regional participation in the trial
  • Manage study management personnel workload based on portfolio, global and regional requirements and expertise level of the individual
  • Facilitate discussions within functional counterparts to manage team priorities and address unplanned demands
  • Recruit, retain and develop top talent to ensure a high performing team culture
  • Facilitate problem-solving, shared learning and decision-making across clinical functions
  • Participate in risk assessments at the clinical plan level and ensures development and implementation of cross-functional risk management plans at the trial level
  • Ensure inspection readiness of respective study team(s). Oversees and coaches CTPMs in the timely documentation of deviations, creation of story boards or issue summary documents (e.g. for high risk areas/hot topics)
  • Oversee and provide direction in obtaining appropriate personnel involvement as compliance issues are identified which require further action or follow-up
  • Ensure that team members adhere to and complete trainings related to GCPs, global SOPs, and clinical best practices

Requirements
  • Bachelors or University degree (scientific or health-related field preferred) and 5 years clinical research experience or relevant experience in a scientific or health-related field; or an advanced degree
  • Minimum of 5 years clinical trial experience with a strong working knowledge of the clinical research process
  • Demonstrated technical and process expertise in clinical trial development. Must understand the drug development process and interdependencies of various tasks and functional groups.
  • Strong communication skills. Communicates effectively up and down in an organization and maintains confidentiality with respect to strategic and personnel matters
  • Proven ability to coach others
  • Strong people and leadership skills with demonstrated ability to influence and lead across clinical functions.
  • Strong interpersonal, teamwork, and negotiation skills
  • Strong self-management and organizational skills
  • Must be capable of managing staff virtually and across-borders and cultures, demonstrating an understanding of cultural differences
  • Previous supervisory experience
  • Global clinical trial experience
  • Prior experience with the management of business plans
  • Demonstrated strong business skills including the ability to understand and facilitate planning processes across clinical functions
For more information, please contact Sinéad Cullen on +353879500821 or [email protected]