Job Description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Responsible for the overall management of the strategy and operations of the Clinical Research Unit (CRU). This includes responsibility for resourcing and study planning, metrics, performance management, supervision and mentoring of direct reports.

Additionally, the role includes management of study portfolio activities, strategic development of the facility (in conjunction with the Managing Director) and identifying and estimating

Capex requirements.

Ensures that CRU operations adhere to Good Clinical Practice (GCP) and/or GMP as appropriate, all regulatory requirements and standard operating procedures. Leads or sponsors

local and global initiatives relating to clinical research.

CORE JOB TASK

Project Management and Planning

· Has overall responsibility for CRU capacity and ensures that studies are planned and executed according to committed timelines.

· Maintains plans for short-term and long-term study activities at LCCP.

Portfolio Management

· Leads strategy for LCCP CRU study portfolio ensuring appropriate study types and volume.

· Actively participates in global scheduling and sourcing discussions with early phase clinical operations and business units.

· Works with Lilly partners to source facilities and studies outside LCCP as appropriate.

Operational Functioning

· Accountable for overall operation and performance of LCCP CRU. Accountable for utilisation of CRU staff and equipment resources.

· Responsible for organisational structure of CRU staff, and accountable for CRU Team performance.

· Develops annual CRU business plan (including staffing and budgeting).

· Provides and reviews CRU financial data for OPEX and CAPEX forecasting and reporting.

· Ensures appropriate assignment of operational work to the CRU staff.

· Accountable for metrics for clinical activity at the study milestone and CRU usage level. Drives LCCP wide metrics reporting.

Regulatory Compliance

· Ensures studies are carried out in accordance to approved protocol, IRB requirements, Good Clinical Practice (GCP), Lilly global policies and local standard operating procedures.

· Reviews relevant Safety & Efficacy Quality System (SEQS) procedures in liaison with appropriate Subject Matter Experts, the Area Quality Manager or equivalent, and the Medical Director. Provides input for periodic review of local SOPs and approval of changes, additions and removal of SOPs for the CRU, Pharmacy and other relevant procedures.

· Ensures compliance of personal and staff training. Works with the Quality team to ensure appropriate curricula remain in place for staff groups.

· Maintains awareness of local and (where relevant) global regulatory requirements to ensure compliance of business operations.

· Oversees IRB submissions and liaises with Ethics Committees as needed.

· Participates in applicable audit and inspection visits by Lilly and external agencies and ensures follow-up to issues takes place.

· Is a key member of the Quality governance committee and leads remedial initiatives.

Technical Expertise

· Provides process and execution expertise to problem solving and process improvement activities within LCCP and across the early phase medical organization.

· Maintains external focus for activities and initiatives that have the potential to benefit/impact the global Lilly organization.

· Liaises with Clinical Pharmacology leadership and functional teams to understand and implement technical requirements.

People and Leadership

· Attracts, retains and develops a diverse workforce. Participates in the recruitment of new employees.

· Provides a work environment for employees in which performance and results are valued and in which individuals are learning and growing developmentally.

· Direct supervision of CRU Team Leaders.

· Develops career path/prospects for CRU employees. Ensures all employees have a performance management plan and that interim and final reviews are carried out by appropriate supervision. Recommends promotions and performance and salary increments. Maintains a safe working environment.

· Demonstrates leadership external to LCCP in order to ensure appropriate representation of CRU and staff across the global organization.

REQUIRED QUALIFICATIONS AND EXPERIENCE

· Bachelor degree in health/science/management.

· Minimum 5 years experience in clinical research, experience in early phase/clinical pharmacology studies preferred.

· Operational management experience preferred.

OTHER INFORMATION

· Ability to travel about 20 – 30% of time.

· Ability to participate in meetings outside of core hours on a routine basis.

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 to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

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.

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