Associate Director Clinical Development
Our client, a global pharma company, is continuing to add talented clinical professionals to their Clinical Development team, and is 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.
Escalate related issues to appropriate parties for awareness and resolution.Collaborate 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.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 ensure development and implementation of cross-functional risk management plans at the trial level.Ensure inspection readiness of respective study team(s).
Oversee and coach CTPMs in the timely documentation of deviations, creation of storyboards 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: Bachelor's or University degree (scientific or health-related field preferred) and 5 years of 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 ******
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