Associate Director Clinical Development
5 hours ago
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 sinead.cullen@lifescience.ie
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