Overview
Associate Director - Clinical Development leads consultants, associates and assistants supporting trials within the Clinical Development (CD) organization, ensuring a high-performance team culture. The role enables asset strategy, drives cross-functional collaboration, and aligns trial-level planning and execution with strategy and timelines. The Manager is responsible for clinical operational oversight of regional/global study-level deliverables including trial enrollment targets, ensuring regulatory compliance and clear process implementation.
Responsibilities
* Business Planning: Partners with functional, cross-functional and team leadership to provide operational input into the feasibility and resource requirements for clinical plans. Provides strategic direction to CTPMs to drive regional/global enrollment strategy and milestones; escalates issues for awareness and resolution. Collaborates with Medical Sourcing, Procurement, CPM, and compound Team Management to 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: Aligns resources based on team priorities and regional participation; manages study management personnel workload; facilitates discussions to manage priorities and unplanned demands; recruits, retains and develops top talent to sustain 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 plan level and ensures development and implementation of cross-functional risk management plans at the trial level; ensures inspection readiness of study teams and oversees documentation of deviations and issue summaries; ensures appropriate personnel involvement for identified compliance issues.
* Training and Compliance: Maintains curriculum maps and training programs; ensures adherence to GCPs, global SOPs, and clinical best practices; coaches and monitors training compliance for staff members.
* Application/Improvement of Processes: Generates innovative ideas and drives process improvements within the clinical organization; supports sharing of new learning opportunities and technologies; uses metrics to assess program status and opportunities for improvement; participates in reviewing and implementing new clinical trial processes.
* Communication: Partners with cross-functional leadership to resolve operational issues; facilitates vendor discussions as appropriate.
* Performance Management: Manages performance processes for staff, including objective setting, progress review, timely feedback, and documentation; handles salary administration and talent assessment/succession planning for direct reports.
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 strong working knowledge of the clinical research process.
Additional Preference
* Demonstrated technical and process expertise in clinical trial development; understanding of the drug development process and inter-dependencies of tasks and functional groups.
* Strong communication skills; maintains confidentiality regarding strategic and personnel matters.
* Proven ability to coach others; strong leadership and ability to influence across clinical functions.
* Strong interpersonal, teamwork, negotiation, self-management and organizational skills.
* Ability to manage staff virtually and across borders/cultures, with understanding of cultural differences; prior supervisory experience; global clinical trial experience; 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.
Lilly is committed to equal employment opportunities and 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.
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