Associate Vice President, Regulatory Strategy

Lilly • Boston, MA

1d

About The Position

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.
Organization Overview:
Verve Therapeutics, a wholly owned subsidiary of Eli Lilly & Company, is a clinical-stage genetic medicines company established with a mission to solve the global health epidemic of cardiovascular disease. Founded by world-leading experts in cardiovascular medicine, human genetics and gene-editing, Verve is pioneering a new approach to the care of cardiovascular disease, potentially transforming treatment from chronic management to single-course gene editing medicines.
Responsibilities:
The Associate Vice President, Regulatory Strategy will provide strategic regulatory leadership for the advancement of our gene editing therapies. This leader will be responsible for overseeing development and implementation of advanced global regulatory strategies as well as the day-to-day management of regulatory activities to support multiple early-stage global programs. This role requires deep regulatory expertise, strong scientific competence, and the ability to lead through complexity in a fast-paced, innovation-focused environment.

Requirements

• Advanced degree in biology, chemistry or closely related field
• 15+ years of relevant industry experience with roles of increasing responsibility and scope

Nice To Haves

• PhD or PharmD strongly preferred
• Previous experience with complex biologics, genetic editing, or gene therapy products
• Prior experience in a scientific and/or technical setting to allow understanding of experiments, documentation and data
• Ability to take broad abstract concepts and distill them down into a vision with an actionable plan
• Ability to apply critical thinking to foreshadow and resolve challenges and roadblocks to allow the organization to push forward
• Ability to analyze data to drive conceptual thinking and decision making
• Excellent written and verbal communication skills, exceptional listening skills, strong presentation skills, and good negotiating and influencing skills

Responsibilities

• Lead and develop a team of leaders, fostering a culture of accountability, inclusion, and high performance
• Maintain oversight of regulatory activities including but not limited to clinical trial applications, IND amendments, annual reports, safety reporting, expedited program applications, and meetings with global health authorities
• Provide strategic regulatory input into content of relevant sections of project/product specific documents submitted to global regulatory agencies and ensure that these documents meet high scientific standards and regulatory requirements
• Provide leadership to resolve critical regulatory issues and bring the appropriate partners and regulatory experts together as needed
• Support Global Regulatory Lead(s) in providing robust regulatory advice and plans to the various project teams to ensure that the business needs are in compliance with regulations and/or regulatory advice received from the agencies
• Coach and mentor direct reports, investing in their professional growth and building leadership capability across the organization
• Monitor the development of new regulatory requirements or guidance documents and regulatory precedent to advise product teams of any impact on the business or development programs and to ensure alignment with evolving regulatory requirements in the gene editing space
• Build and maintain strong relationships with cross-functional teams as well as senior leadership

Benefits

• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees