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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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$162,000 - $261,800

Purpose Of The Job

At JP Morgan 2024, Dave Ricks announced Lilly Catalyze360, our external innovation organization dedicated to biotech collaboration which is comprised of three pillars: Lilly Ventures, providing capital direct to biotechs and via a fund-of-funds investment strategy; Lilly Gateway Labs, a best-in-class network of biotech incubators; and ExploR&D.

Within ExploR&D our mission is 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. With the pace of technological disruption accelerating, ExploR&D also affords Lilly an agile way to pilot and deploy new technologies and vendor solutions that can increase the speed and efficiency in the way drugs are discovered and developed, both for our biotech collaborators, and by providing de-risked opportunities to evolve how Lilly and LRL operates.

The Senior Director/Executive Director is responsible for managing all Regulatory activities (strategy and implementation) for assigned programs across different therapeutic areas and geographies, with focus on US, UK, EU, and Canada. The Senior Director/Executive Director works with a multidisciplinary team to construct a plan to develop and test key scientific hypotheses, discharge risks regarding molecule safety and efficacy, and enable effective decision-making related to molecule development.

Consult on global regulatory strategy, advise on IND/CTA content including gap analysis and recommendations, advise on expedited pathways, orphan drug designation, and other regulatory advice meetings, and provide regulatory education.Provide regulatory leadership to program teams supporting first-in-human clinical trials through clinical proof of concept, including advice and leadership for regulatory interactions.Responsible for 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 and clinical summaries) in accordance with general standards, guidelines, procedures, and appropriate regulations.Expect and understand the high-level issues affecting the drug development process and help drive effective solutions. Provide assessment of regulatory risk, mitigation and contingency planning to support decision-making through collaboration with cross-functional team members.Develop adaptive regulatory strategies that are fit for purpose and forward thinking to enable seamless hand-off once proof of concept has been established. Regulatory strategies will focus on the key scientific data needed to support innovative development pathways, as appropriate for the asset and therapeutic area.Lead, network, identify, and manage all regulatory and pharmacovigilance operations outsourcing/third party vendor relationships and deliver project milestones on time, on budget, and within scope.Advise on infrastructure, IT solutions, use of artificial intelligence, and standard operating procedures to support the ExploR&D organization.Perform due diligence reviews for incoming assets.Manage relationships with external partners.

Basic Qualifications

Advanced graduate degree (MS, PharmD, PhD, MD) in a health-related or scientific field from an accredited college or universityAt least 7 years of regulatory affairs experience with research-based drug development, including early phase (first in human, Ph1/Ph2) submission experience.Demonstrated understanding of clinical drug development and regulatory affairs, including regulations in the US, UK, EU, and CanadaSkilled at managing alliance/CRO relationships

Additional Skills/Preference

Openness towards cultural diversity, including different work stylesDemonstrated leadership abilities/behaviors, particularly entrepreneurial mindset, strategic thinking, and teamworkDemonstrated communication/interpersonal skills and ability to connect and influence at various levels across disciplines, both externally and internallyExcellent teamwork, organizational, and negotiation skillsAble to independently manage workload and adjust priorities as neededProactively address potential issuesWell-grounded in business principles with the ability to maximize the probability of success for individual assets and the overall portfolioDeep knowledge of the drug development processExperience in working with cross-functional teams across multiple therapeutic areasAbility to influence others (both cross-functionally and within the function) to create a positive working environmentImplementation of artificial intelligence tools

Additional Information

This role will report to the Associate Vice President, ExploR&D, Regulatory Affairs, Medical Writing, and Quality. Core work hours, Monday-FridayFlexible global locations with preference for London UK, Indianapolis IN, Boston MA, or San Francisco CA.

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 is an EEO/Affirmative Action Employer and 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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