Associate VP – Global Regulatory Policy and Strategy (Genetic Medicine)

Eli Lilly and Company; Indianapolis (IN); On-site; USD 238,000 - 350,000; Full time

Job summary

A leading global healthcare company seeks an Associate Vice President for Global Regulatory Affairs. This pivotal role involves shaping regulatory policy for genetic medicine and influencing strategy across various stages of product development. The ideal candidate will possess a strong network in regulatory environments and significant experience in policy advocacy.

Benefits

Comprehensive benefit program

Eligibility for company bonus

401(k) and pension options

Qualifications

• Minimum of 10+ years of relevant experience in research, regulatory, policy, and/or advocacy.
• Established external network in the regulatory policy environment.
• Experience engaging in external consortia.

Responsibilities

• Develop strategies and regulatory policy positions for genetic medicine projects.
• Advise on global regulatory strategy for cell and gene therapy products.
• Cultivate relationships with key regulators and external players.

Skills

Regulatory policy development

Strategic planning

Stakeholder engagement

Analytical thinking

Risk management

Education

Master’s or Doctorate Degree

Job description

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.

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.

Organization Overview:

Global Regulatory Policy & Strategy 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 Affairs, Global Regulatory Policy & Strategy (Genetic Medicine and Neuroscience) role is to elicit, develop, and progress Lilly’s genetic medicine and neuroscience regulatory policy positions and related advocacy strategies globally 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:

Drive Regulatory Policy

• Develop strategies and regulatory policy positions for highly visible genetic medicine projects that have significant business impact on the company
• 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 genetic medicines
• 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 Lilly Genetic Medicine, colleagues and GRA colleagues including global regulatory leads, among others, to create evidence and science-based policy positions
• Build and implement a tactical policy plan
• Impact GRA and across Lilly

Guide Development and Regulatory Strategy

Advise on global regulatory strategy development and execution with cross-functionalkey stakeholders for cell and gene therapy products across all stages of productdevelopment (i.e., IND-enabling to BLA)
Provide strategic regulatory guidance on the Preclinical, Clinical, and Commercialdevelopment of cell and gene therapy products, including interpretation of final anddraft regulatory guidance related to cell and gene therapy
Anticipate global regulatory changes related to cell and gene therapy and proactivelyrevise strategic plans accordingly
Understand and interpret data (e.g., Nonclinical, Clinical, etc.) to effectively guide globalregulatory strategy execution to maximize global regulatory success
Contribute to shaping the regulatory science environment within Lilly Genetic Medicineand across the broader organization
Proactively participates in risk management / mitigation efforts related to cell and genetherapy regulatory strategy
Influence key stakeholders to devise creative solutions to the unique challengespresented by cell and gene therapy products in order to maintain agility and meet globalregulatory timelines and strategic needs
Manage and / or mentor junior team members to ensure broad understanding of theglobal regulatory strategy for cell and gene therapy products and continuousimprovement of strategy execution

Exert External Influence

Create and foster strategic relationships with key regulators and other external playersto 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 cancontribute
Attend and present at key industry conferences to showcase Lilly policy positions.
Build upon existing relationships and maintain strong collaborations with externalpatient/professional groups, think-tanks, academic groups, policy organizations andassociations
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

Basic Qualifications:

• Master’s or Doctorate Degree with minimum of 10+ years of relevant, research, regulatory, policy, and/or advocacy experience.

Additional Skills and Preferences:

Established external network in regulatory policy environment
Experience engaging in external consortia and passionate about crafting policy issues
Recognized experience in leading/implementing public policy or regulatory policycampaigns
Previous experience shaping regulatory policy issues related to genetic medicinedevelopment
Prior work with organizations such as FDA, BIO, Alliance for Regenerative Medicine,ASGCT, ESGCT, and PhRMA
Proficient in researching and writing briefings, positions, and high-levelcommunications for executive staffing
Ability to influence without authority, demonstrate resourcefulness, and operateindependently

Additional Information:

Travel up to 20%
Position reports to Vice President, Global Regulatory Policy and Strategy with dottedline reporting relationship to Vice President, Chief Development Officer | Gene Therapy
Position Location – Indianapolis, IN, Washington DC, or Remote

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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

$238,500 - $349,800

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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