Associate Director - Trial Capabilities - Therapeutic Project Lead

We’re looking for people who are determined to make life better for people around the world.At Eli Lilly Cork, 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 41,000 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 patients around the world. Eli Lilly Cork is made up of a talented diverse team of over 1,600 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.Come join our team - Be Creative, Be an Innovator, and most of all, Be YourselfThe Clinical Central Services & Innovation (CCSI) organization is responsible for strategically planning and supplying materials, trial support services and innovative capabilities to support the execution of clinical trials globally for all business units across all phases of development. This group is within the Clinical Capabilities organization and partners across functions within the Clinical Design, Delivery and Analytics (CDDA) and Product Research and Development (PRD) to influence trial design and provide solutions to operationalize these trials and enable asset strategies across the portfolio.Overview:The purpose of the Associate Director, Trial Capabilities (Therapeutic Project Lead) role is to lead Clinical Trial Capabilities in support of clinical development. The EMEA Associate Director, Trial Capabilities (Therapeutic Project Lead) 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 Trial Capabilities 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 always ensure inspection readiness by following GCP; any local/regional requirements and Lilly operating procedures.Primary Responsibilities:This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.Clinical Trial LeadershipAccountable for defining and implementing the staffing strategy for trial capabilities (site activation, site contracting, Clinical Finance, etc.) enabling global clinical trial delivery.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 Investigator 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.Organizational LeadershipLead Trial Capabilities 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.People DevelopmentIdentify 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 deliveryMinimum Qualification Requirements:Bachelor’s degree preferably in a scientific or health related fieldExperience in clinical practice, clinical research or pharmaceutical medicine, and the drug development process.Other Information/Additional Preferences:At least five (5) years clinical trial experience or relevant experience preferredExcellent communication (written and verbal), interpersonal, organizational and negotiation skillsStrong knowledge of quality systemsProject management experience.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.#WeAreLilly