Associate Director - Clinical Development Neuroscience
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives.
The Clinical Development Associate Director provides leadership and direction for consultants, associates and assistants supporting trials within the Clinical Development (CD) organization. The position ensures a high‑performance team culture and drives cross‑functional collaboration to achieve the goals of clinical development.
Responsibilities
Business Planning
Partners with functional, cross‑functional and team leadership to provide operational input into 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 and 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.
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) and coaches CDTLs in timely documentation of deviations and issue summary documents.
Provides direction in obtaining appropriate personnel involvement as compliance issues are identified which require further action or follow‑up.
Training and Compliance
Has shared responsibility with training group to ensure 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 CDTLs capabilities and behaviors, assists in coaching or identifies appropriate coaches for consultants, associates and assistants to enable them to become proficient.
Monitors training compliance for consultants, associates and assistants ensuring timely completion of all required courses.
Promotes consistent use of GCPs, global SOPs, and best practices to ensure quality in clinical research activities.
Application/Improvement of Processes
Generates innovative ideas, leads and/or provides input into new processes and process improvements within the clinical organization.
Encourages staff to utilize metrics data to assess the current status of the clinical program and seek opportunities for improvement.
Participates in reviewing and implementing new clinical trial processes within teams and assesses their impact on project goals.
Communication
Partners with other cross‑functional leadership to identify and facilitate 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 giving timely objective feedback.
Completes salary administration for reporting staff members.
Completes talent assessment and succession planning for direct reports.
Basic Requirements
Bachelor’s or university degree (scientific or health‑related field preferred) and 5 years clinical research experience, or an advanced degree.
Minimum of 5 years clinical trial experience with a strong working knowledge of the clinical research process.
Additional Preference
Demonstrated technical and process expertise in clinical trial development.
Strong communication skills and ability to maintain 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.
Capability to manage staff virtually and across borders and cultures.
Previous supervisory experience.
Global clinical trial experience.
Prior experience with management of business plans.
Demonstrated strong business skills and ability to facilitate planning processes across clinical functions.
Additional Information
Travel may be required.
Equal Opportunity Employer
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation, please complete the accommodation request form at https://careers.lilly.com/us/en/workplace-accommodation for further assistance.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
#J-18808-Ljbffr