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Position Overview
The Clinical Development Associate Director provides leadership and direction for the consultants, associates and assistants supporting trials within the Clinical Development (CD) organization and ensures a high performance team culture.
This position enables asset strategy, focuses on results, and emphasizes and drives cross-functional team collaboration to the achievement of goals and objectives of clinical development within the broader Clinical Design Delivery Analytics (CDDA) organization.
Responsibilities:
* Business Planning
Partners with functional, cross-functional and team leadership to provide operational input into the feasibility and resource requirements associated with clinical plans.
* Provides strategic direction and leadership to CTPMs to enable them to drive the implementation of the Regional/Global enrollment strategy, to accomplish milestones to plan.
* Collaborates with Medical Sourcing, Procurement, CPM, and compound Team Management to provide and enable decisions related to internal/external-sourcing options.
* Works closely with the clinical project manager to ensure planning databases are accurate and up-to-date.
* Resource Management
Works to align resources based upon team prioritization decisions and regional participation in the trial.
* Manages study management personnel workload based on portfolio, global and regional requirements and expertise level of the individual.
* Facilitates 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.
* Trial Management Expertise
Facilitates problem-solving, shared learning and decision-making across clinical functions.
* Participates in risk assessments at the clinical plan level and ensures development and implementation of cross-functional risk management plans at the trial level.
* Ensures inspection readiness of respective study team(s).
* Oversees and coaches CTPMs in the timely documentation of deviations.
* Training and Compliance
Has shared responsibility with training group to ensure that curriculum maps and training programs/courses are maintained appropriately for staff members.
* Ensures that team members adhere to and complete trainings related to GCPs, global SOPs, and clinical best practices.
* Evaluates CTPMs capabilities and behaviors, aids in directly coaching or identifies appropriate coaches for consultants, associates and assistants.
* Application/Improvement of Processes
Generates innovative ideas, leads and/or provides input into new processes and process improvements within the clinical organization.
* Actively supports staff to share any new learning opportunities or technologies within or across clinical functions.
* Encourages staff to utilize metrics data in order to assess the current status of the clinical program.
* Communication
Partners with other cross-functional leadership in identifying and facilitating resolution of clinical trial operational issues.
* Facilitates high-level discussions with vendors, as appropriate.
* Performance Management
Manages the Performance Management process for staff members by providing input in yearly objectives, reviewing progress, and providing timely feedback.
* Completes salary administration for reporting staff members.
Basic 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.
Additional Preferences:
* Demonstrated technical and process expertise in clinical trial development.
* Strong communication skills.
* Proven ability to coach others.
* Strong people and leadership skills.
* Strong self-management and organizational skills.
* Previous supervisory experience.
Additional Information:
* Travel may be required.
* Eli Lilly and Company is committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs.