Senior Director – Global Regulatory Policy (Oncology Business Unit), GRA

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.

Organization Overview:

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 Senior Director – Global Regulatory Policy (Oncology Business Unit (OBU)) role is to elicit, develop, and progress Lilly’s OBU regulatory policy positions and related advocacy strategies to enable innovation and ultimately improve outcomes for patients. 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.

Responsibilities:

• Establish Regulatory Policy Positions and External Engagement Strategies
• 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 medicines targeting various types of cancers
• 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 OBU colleagues and regulatory team members, among others, to create evidence and positions
• Build and implement tactical policy plan

Exert External Influence

• 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

Basic Qualifications:

• 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

Additional Skills and Preferences:

• Experience engaging in external consortia passionate about crafting policy issues
• Established external network in subject matter area of focus
• Recognized experience in leading/implementing public policy or regulatory policy campaigns
• Previous experience shaping regulatory policy issues related to oncology
• Prior work with organizations such as Friends of Cancer Research, LUNGevity, American Association for Cancer Research, or Cancer Support Community
• Proficient in researching and writing briefings, positions, and high-level communications for executive staffing
• Ability to influence without authority, demonstrate resourcefulness, and operate independently

Additional Information:

• Travel up to 20%
• Position reports to Associate Vice President, Global Regulatory Policy with dotted line reporting relationship to Associate Vice President, Global Regulatory Affairs, OBU
• Position Location – Indianapolis, IN, Washington DC or Remote

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law). 

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