Job Title: Associate Director Clinical Development
The company is seeking a highly experienced and skilled professional to join their Clinical Development team as an Associate Director.
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.
* 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).
* Oversee and coach 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:
* Bachelor's 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.