Associate Director -Regulatory Affairs and Professional Practice Pharmacist, Lilly Direct Pharmacy

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.

About LillyDirect

U.S. consumers navigate considerable complexity in managing their healthcare, and their experience is often vastly different from the personalized, seamless engagements we have come to expect from the banking, retail, and travel industries. While the pandemic led to innovations in virtual care, alternate models for distribution, and integrated health and wellness solutions, these innovations focus on specific points in the patient journey rather than a holistic, end-to-end patient experience.

Launched in January 2024 for people in the U.S. living with obesity, migraine, and diabetes, LillyDirect is an industry-first digital healthcare experience designed to support and empower patients on their care journey. Through this new operating model, Lilly aims to improve patient access to care, help reduce healthcare costs, and enable better outcomes for people living with chronic disease. The rapid uptake of LillyDirect since its launch underscores the significant unmet need of people struggling to navigate the complex U.S. health care system. As such, we are seeking to expand our offerings and scale business operations to enable better outcomes for patients.

About the Role

LillyDirect Pharmacy is seeking a senior, deeply experienced Pharmacist to serve as the in-house authority on regulatory affairs and professional practice. This is not a generalist operations role. The position is designed for a pharmacist who has built a career at the intersection of pharmacy practice, board-of-pharmacy regulation, and the broader professional pharmacy community, and who can bring that depth to bear as LillyDirect scales its direct-to-patient operating model.

The successful candidate has demonstrated regulatory and compliance leadership across a substantial pharmacy footprint, brings standing within the broader pharmacy professional community, and has a track record of translating regulatory complexity into clear operational guidance. Prior engagement with state regulatory bodies, state pharmacy associations, or national pharmacy organizations through formal service, advisory, or leadership roles is highly valued. The role partners closely with LillyDirect operations, quality, legal, and commercial leadership to ensure that pharmacy practice across the LillyDirect ecosystem reflects the highest standards of patient safety, regulatory compliance, and professional practice.

Key Responsibilities

• Serve as LillyDirect's in-house subject matter expert on Indiana pharmacy law, Board of Pharmacy regulation, federal pharmacy practice standards, and the regulatory environment governing direct-to-patient pharmacy.
• Engage with relevant state and national pharmacy bodies, regulatory agencies, and professional associations as needed to support LillyDirect's regulatory posture and represent the company's interests appropriately, consistent with all applicable ethics requirements.
• Monitor pending legislation, board rulemaking, national model legislation and standards, and federal regulatory developments; synthesize implications for LillyDirect leadership and translate them into operational and policy responses.
• Lead the professional practice agenda for LillyDirect Pharmacy, including patient safety, pharmacist conduct expectations, and standards of care.
• Partner with Quality Assurance, Compliance, Risk Management, and Legal on regulatory matters, audit response, board correspondence, and inspection readiness.
• Partner with Lilly's pharmacy intern recruiting and preceptorship point of contact, and with HR, to support pharmacy talent pipeline development; serve as the pharmacy practice subject matter expert in those engagements.
• Provide professional development and mentorship to LillyDirect pharmacists; participate in pharmacist hiring, onboarding, and competency assessment.
• Provide consultation and team support for technical and regulatory knowledge and activities related to pharmacy practice.
• Support Lilly commercial oversight and issue resolution where pharmacy practice expertise is required.
• Verify accuracy of prescription orders and resolve issues with prescribers and patients when needed.
• Collaborate with internal teams (logistics, commercial operations, customer support, IT) to streamline processes a