At Eli Lilly and Company, we unite caring with discovery to make life better for people around the world. Our employees work together 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 offer a premium workspace across our campus in Little Island, Cork, complete with flexible hybrid working options, healthcare, pension, and life assurance benefits, subsidised canteen, onsite gym, travel subsidies, and on-site parking.
We are 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.
Career Overview
This is a fixed-term position (approximately 12-15 months) supporting ExploR&D Regulatory Affairs based in Cork.
Purpose of the Job
Within ExploR&D, our mission is to unleash Lilly's world-leading capabilities and know-how to accelerate the science of our biotech collaborators to value inflection, and to patients.
The Associate Director provides strategic, tactical, and operational direction and support to deliver global regulatory strategies from candidate selection to clinical proof of concept for assigned assets.
Core Job Tasks
* Collaborate to develop and initiate effective regulatory strategies, focused on preparing CTA/INDs to support Phase 1 and 2 clinical development of externally owned assets.
* Provide guidance on nonclinical, toxicology, and CMC requirements for CTA/IND submission.
* Advise on dose selection, study participants, and clinical protocol designs, focused on safety stopping rules and pharmacovigilance oversight.
* Anticipate potential issues that could impact approvability of CTA/IND submissions and develop risk mitigation and contingency plans to address proactively.
* Develop adaptive regulatory strategies that are fit for purpose and forward thinking to enable seamless hand-off once proof of concept has been established.
* Manage regulatory and pharmacovigilance outsourcing to vendors, including oversight of DSUR preparations and Safety Review Committees.
* Ensure consistency, quality, compliance, and timeliness of regulatory deliverables, including the regulatory components of the documents needed to support CTA/IND submissions.
Exercise Accountability for Knowledge Transfer across ExploR&D and GRA
* Attend regulatory related seminars and presentations as feasible.
* Proactively share learning and expertise with ExploR&D functional leadership and GRA.
* Exemplify Team Lilly behaviors: Include, Innovate, Accelerate, Deliver.
* Model the innovation and leadership behaviors and regulatory excellence attributes as described in the Lilly GRA white papers.
* Effectively share regulatory intelligence with ExploR&D program teams, ExploR&D functional leadership, and GRA.
* Constructively challenge program teams to reach the best solutions to issues.
* Create and lead in an environment that encourages open discussions on issues to achieve a robust outcome on business decisions.
* Effectively manage upward and cross-functional communications.
* Effectively communicate the impact of changes in regulations and/or guidance applicable to ExploR&D programs to senior management and program teams.
Minimum Job Requirements
* Bachelor's degree in scientific or health sciences discipline; prefer advanced graduate degree (MS, PharmD, PhD, MD) in a health-related or scientific field.
* Industry-related experience in regulatory affairs and/or drug development experience for a minimum of 5 years, preferably with early phase clinical development experience.
* Demonstrated understanding of global clinical drug development regulations, procedures, and practices, with focus on US, Canada, UK, EU, and Australia.
* Openness towards cultural diversity, including different work styles.
* Skilled at managing alliance/vendor relationships.
* Demonstrated leadership abilities/behaviors, particularly entrepreneurial mindset, strategic thinking, and teamwork; able to adapt to diverse interpersonal styles.
* Demonstrated communication/interpersonal skills and ability to connect and influence at various levels across disciplines, both externally and internally.