Lilly Associate VP – Global Regulatory Policy (Genetic Medicine, Rare Diseases, Expedited Pathways), GRA in Indianapolis, Indiana
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.
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Global Regulatory Policy strives to enable Lilly to deliver innovative regulatory results by identifying policy hurdles and emerging trends, developing advocacy plans built upon science-based positions, engaging broad partner networks, and ultimately effecting change in regulatory policies that advance patient outcomes, reduce regulatory risk, and improve efficiency in drug development. The purpose of the Associate Vice President – Global Regulatory Policy (Genetic Medicine, Rare Diseases and Expedited Pathways) role is to elicit, develop, and progress Lilly’s cell and gene therapy (CGT) regulatory policy positions and related advocacy strategies to enable innovation and ultimately improve outcomes for patients. You will also manage Lilly’s regulatory policy and advocacy with respect to treatments for rare diseases, new modalities, and expedited approval pathways. In this role, you will represent Lilly in external consortia and policy-related forums and rely on a strong pre-existing network of external collaborators.
Develop strategies and regulatory policy positions for highly visible projects that have significant business impact on the company, including those for: CGT, rare diseases, new modalities, and expedited approval pathways
Gain consensus on Lilly’s priority global regulatory topics consistent with GRA’s overall regulatory policy vision, which will center around topics that encourage innovation in drug development and regulatory review of CGT medicines, rare diseases, new modalities, and expedited approval pathways
Critically review and analyze regulatory and legislative proposals and identify possible policy, political, and financial impact to Lilly in cooperation with cross-functional partners
Articulate regulatory policy challenges, problem statements and desired future states
Identify and develop data and evidence to support company positions, working in collaboration with cross-functional colleagues
Bring in or represent external viewpoints as company positions are developed
Cultivate relationships and collaborate with internal subject matter authorities, including Prevail, Akouos, and other Lilly Genetic Medicine colleagues and regulatory team members, among others, to create evidence and science-based policy positions
Build and implement tactical policy plan
Impact GRA and across Lilly
Exert External Influence
Create and foster strategic relationships with key regulators and other external players to identify and anticipate opportunities for growth
Anticipate changes in the external environment and develops action plans
Engage on behalf of Lilly in health policy-related forums
Triage opportunities to engage externally so that the appropriate company experts can contribute
Attend and present at key industry conferences to showcase Lilly policy positions.
Build upon existing relationships and maintain strong collaborations with external patient/professional groups, think-tanks, academic groups, policy organizations and associations
Impact patient outcomes through collaboration across partner groups
Effectively lead, engage and partner
Exemplify Team Lilly behaviors: Include, Innovate, Accelerate, Deliver in internal and external interactions
Model the innovation and leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers
Engage in forums that share regulatory information across GRA components and other Lilly teams and business partners
Create and lead in an environment that encourages open discussions on issues to achieve a robust outcome on business decisions
Make significant decisions guided by industry norms and business strategy
Influence senior leadership, regulators, and/or external partners on business and technical decisions that have a critical impact on business direction
Influence innovative thinking across multiple functions, geographies, and/or external organizations
Direct the resolution of highly complex business problems with significant impact, using advanced critical thinking
Masters’ degree or Doctorate in relevant policy, public health, regulatory, clinical, legal, business, research, or related field with 5-7 years regulatory/policy/advocacy equivalent experience
OR, Bachelor’s degree with 10 years regulatory/policy/advocacy equivalent experience
Recognized expertise as an external thought leader in CGT regulatory policy
Additional Skills and Preferences:
Established external network in CGT regulatory policy environment
Experience engaging in external consortia and passionate about crafting policy issues
Recognized experience in leading/implementing public policy or regulatory policy campaigns
Previous experience shaping regulatory policy issues related to CGT development, rare diseases, new modalities, and expedited approval pathways
Prior work with organizations such as FDA, BIO, Alliance for Regenerative Medicine, and PhRMA
Proficient in researching and writing briefings, positions, and high-level communications for executive staffing
Ability to influence without authority, demonstrate resourcefulness, and operate independently
Travel up to 20%
Position reports to Vice President, Global Regulatory Policy and Strategy with dotted line reporting relationship to Sr. Vice President-Neurodegeneration Research & Co-Director of Lilly Institute for Genetic Medicines
Position Location – Indianapolis, IN, Washington DC or Remote
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