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 and enhance patient satisfaction.
• Stay current on industry trends and technological advancements related to direct-to-patient pharmacy operations, and translate those into operational changes that drive state-of-the-art execution.
• Contribute to the design and improvement of processes and systems that support pharmacy operations.
• Per the in-office schedule created by the pharmacy scheduler, this position will be expected to work scheduled shifts, which will typically fall Tuesday through Thursday between 9:00 a.m. and 5:00 p.m. Remote work flexibility applies consistent with Lilly's remote work policy.

Basic Qualifications

• Bachelor of Science in Pharmacy or Doctor of Pharmacy (PharmD) degree.
• Active, unrestricted Indiana pharmacist license in good standing.
• Minimum of 5 years of experience in pharmacy practice

• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1

Additional Preferences

• Minimum of 5 years of experience in pharmacy practice, with substantive responsibility for regulatory compliance, patient safety, and professional practice.
• Demonstrated experience working with state Boards of Pharmacy, state pharmacy associations, or national pharmacy bodies (e.g., NABP, APhA) in an official, advisory, or leadership capacity.
• Documented track record of multi-store, multi-unit, or division-level pharmacy operational responsibility, OR equivalent experience as a senior regulatory or professional practice leader within a pharmacy organization.
• Demonstrated active engagement with state regulatory bodies, state pharmacy associations, or national pharmacy organizations through formal service, advisory, committee, or leadership roles.
• Track record of policy engagement, including participation in working groups, task forces, or rulemaking processes that shape pharmacy practice or regulation.
• Demonstrated history of policy engagement with state legislators, federal lawmakers, or licensing agencies on pharmacy law and practice.
• Experience as a Pharmacy Supervisor, District Leader, Professional Practice Leader, or equivalent overseeing a regional chain or multi-unit pharmacy operation and a pharmacist team of 50 or more.
• Experience leading regulatory, safety, and operational store audits across a multi-state footprint.
• Active preceptor or guest lecturer relationship with a college of pharmacy; demonstrated commitment to pharmacist talent development and intern program leadership.
• Strong professional network within the Indiana pharmacy community, including academic, regulatory, and association ties.
• Excellent leadership, organizational, and communication skills; supervisory experience required.
• Strong attention to detail and commitment to patient safety.
• Demonstrated ability to influence and communicate across levels of technical experts and senior leadership.

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

$127,500 - $187,000

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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