Lilly Associate Director - Trial Capabilities - Therapeutic Project Lead in Cork, Ireland
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
The Trial Capabilities Associate Director leads clinical Trial Capabilities in support of clinical development. The EMEA Trial Capabilities Associate Director is accountable for the planning and implementation of the regional EMEA Site Start Up, Maintenance, and Close Out plan for all trials across the TA(s) of responsibility.
The AD will through management of the managers -project leads and partnership with global cross-functional teams, ensure accurate planning and support timely execution of regional Trial Capabilities milestones in alignment with quality standards. The AD leverages their project management, and site activation expertise to achieve these deliverables, providing management and clinical operational expertise to internal and external customer’s/business partners.
The AD will support efforts to enhance Trial Capabilities operational control and oversight including submission and clinical trial application strategy, site budget and contracting, clinical finance and payment, trial records management, trial training, and trial metrics across all therapeutic areas to enable end to end Trial Capabilities deliverables. The AD will ensure inspection readiness at all times by following GCP; any local/regional requirements and Lilly operating procedures.
Clinical Trial Leadership
Design, lead and continuously improve capabilities critical to the success of the organization for delivery of high priority programs and large and complex trials in the region.
Develop strong partnerships with Site Engagement, Design Hub, Clinical Development and Asset Teams, influencing study delivery and provide consultation on country/regional level activities during startup, maintenance, and close out.
Anticipate and mitigate risks and resolve complex and critical risks/issues to enable timely delivery of Trial Capabilities commitments across the region.
Lead and consult internal and external inspections as well as supporting institutions/investigative sites in inspection readiness initiatives.
Leverage scientific and disease expertise within therapeutics areas and utilise strategic knowledge of Lilly’s portfolio and priorities to lead regional prioritization and anticipate future needs for Trial Capabilities.
Lead Trial Capabilities Managers – Project Leads to effectively manage study start-up. Be a resource on local/global regulations, laws, and guidance (e.g., ICH), and assess the impact on local and global processes and ensuring implementation to meet regulatory requirements.
Collaborate with CDDA functions (as Global TC lead in select projects) and understand cross-functional interdependencies to identify opportunities for collaboration and process improvement projects by providing expertise, implement strategies and direct support to ensure completion and implementation.
Provide consultation on Quality and Business Systems, Good Clinical Practices (GCP) and Lilly Medical policies and procedures to achieve inspection readiness and detect and resolve quality issues
Understand and comply with procurements, legal and financial requirements and procedures
Identify and develop robust mechanisms to retain a scientific, technical and operationally capable Trial Capabilities workforce skilled and knowledgeable in clinical development
Effectively manage an agile organization that continuously meets the needs of a changing portfolio.
Acts as a role of subject matter experts, coach and mentor within Trial Capabilities and CDDA organization.
Develop an organizational culture that fosters inclusion and innovation and demonstrates judgment-based decision making in clinical delivery
Bachelor’s degree preferably in a scientific or health related field
At least five (5) years clinical trial experience or relevant experience preferred
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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.