Associate Director, ExploR&D Regulatory Affairs

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 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.

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.

Come join our team – Be Creative, Be an Innovator, and most of all, Be Yourself!

This posting is for 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. Through a unique model that mixes dedicated headcount and flexible use of functional and therapeutic area expertise, we will provide the knowledge and services to enable our collaborator’s programs. Through our work we ensure Lilly is networked with the brightest scientific minds around the world to continue to make Lilly smarter, create value for Lilly and the entire scientific ecosystem, and position Lilly as a partner of choice for biotechs to fuel our industry-leading pipeline with best external innovation.

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. The Associate Director is responsible for managing all regulatory activities (strategy and implementation) for assigned programs across different therapeutic areas and geographies, with focus on US, Canada, UK, EU, and Australia. The Associate Director partners across functions, Sponsors, vendors, and health authorities to construct plans to test key scientific hypotheses, discharge risks regarding asset safety and efficacy, and enable effective decision-making related to asset development.

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 Regulatory and Pharmacovigilance Operational Support

• Provide guidance, with the cross-functional team, on appropriate nonclinical, toxicology, and CMC requirements for CTA/IND submission.
• Provide advice regarding dose selection, study participants, and clinical protocol designs, focused on safety stopping rules and pharmacovigilance oversight.
• Advise when it is appropriate to seek Pre-IND/Pre-CTA advice or consider other regulatory meetings/designations to support innovative development pathways, as appropriate for the asset and therapeutic area.
• 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 (such as clinical protocols, IB, IMPD nonclinical, CMC, and clinical summaries) in accordance with general standards, guidelines, procedures, and appropriate regulations.
• Maintain regulatory logs for each asset and ensure all official communications are archived in the appropriate electronic repositories.

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 (e.g., educational background, work history, etc.) :

• 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.

Effective Communication:

• Excellent oral and written communication skills.
• Demonstrated ability to articulate issues and to provide written materials that may be needed for external training and/or communication of asset plans.

• Demonstrated ability to assess and manage risk in a highly regulated environment.
• Ability to articulate scientific and clinical concepts across a wide range of audiences (including content experts, general and therapeutic management, all team members, etc.).
• Ensures effective cross-functional communication with internal and external experts.
• Effectively responds to queries/comments from Investigators, Regulatory Agencies, Ethics Committees, and vendors.

Additional Skills/Preferences:

• Able to independently manage workload and adjust priorities as needed.
• Proactively address potential issues.
• Well-grounded in business principles with the ability to maximize the probability of success for individual assets and the overall portfolio.
• Deep knowledge of the drug development process.
• Experience in working with cross-functional teams across multiple therapeutic areas.

• Ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.

Additional Information:

• Core work hours, Monday-Friday.
• Travel expected (10-15%).

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