Lilly Senior Director - Ethics & Compliance, Lilly Research Laboratories R&D in Indianapolis, Indiana
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.
Lilly embraces its core values of integrity, excellence and respect for people. These values are integrated in our work ethic and mission. Our Ethics and Compliance organization is looking for a team member to provide E&C leadership to our senior leaders across Discovery & Research, Medicines Development Unit, Clinical Diagnostic Labs and to the overall global LRL and R&D organizations. This role will report to the VP Ethics and Compliance Officer, LRL and Loxo @Lilly Oncology.
The scope of the role is focused on enabling the organization’s adherence to Lilly’s Code of Conduct as defined in The Red Book as well as all applicable US laws, regulations, and industry codes of conduct (US, EFPIA, and IFMPA), including the FD&C Act (as related to promotional activities), FCPA, PDMA, Anti-Kickback laws, False claims act, and OIG guidance. This role will help deliver on the E&C mission to drive the integration of exceptional performance with high integrity across the organization, accomplished through providing Ethics and Compliance counsel, effective compliance business partnering, and result driven compliance advice on overall business strategies, decisions, and activities conducted within R&D and LRL and/or overseen by LRL and through implementation of the 7 elements of an effective compliance program as defined by the OIG.
This position will be the primary point of contact for all functions across R&D and will coordinate compliance support with other areas in Global Ethics and Compliance (such as Business Unit Ethics and Compliance, E&C Operations, and global geographies). This role provides technical leadership, setting the strategy and direction within E&C to enable the implementation of an effective compliance program in R&D functions and connecting to the various LRL/R&D sites. As part of this organizational responsibility, this leader is also responsible for developing and implementing operations necessary to ensure reporting and monitoring requirements are met. This role will handle integration efforts for new business development and subsidiaries added to R&D and LRL business areas and CDL (clinical diagnostic lab) compliance oversight. The Sr. Director coordinates with Quality, Legal and/or HR to support any Corrective/Preventative and Disciplinary Actions resulting from compliance failures and CAPAs. Regular networking with quality, audit, legal and regulatory as well as with compliance colleagues internally and externally is essential to ensure alignment with company policies and compliance objectives. This role also contributes as a member of the relevant leadership teams (e.g. Research and Development, Bioethics Advisory Committee).
Through effective partnering with LRL and R&D leadership, and oversight by E&C, ensure business discussions and decisions encompass and consistently take into consideration appropriate ethics and compliance elements, and that there is clear business ownership of ethics in all decisions taken.
Ensure that E&C program elements are appropriately tailored to R&D activities and operations, enabling the business to meet business goals in an effective and compliant manner and foster agility and innovation.
Deliver effective compliance business partnering, and solution seeking compliance advice on overall business strategies, decisions, and activities conducted within R&D functions and/or supervised by LRL; including providing recommendations of ways to mitigate or resolve potential E&C risk throughout R&D functional areas.
Influence leadership through effective elucidation of the external environment and internal policies/standards.
Collaborate with leadership to ensure the key elements of compliance program are built into local governance and decision forum, business and operational processes, and training.
Lead E&C activities associated with research and development. Given next generation development, new/evolving R&D sites, innovation goals, new clinical trial strategies and an increasing range and scope of collaborations, ensure reliable controls are implemented and understood – i.e. ensure clarity in both the ‘what’ and the ‘why’ so that business activities are performed appropriately. This includes supporting and advising various programs/teams and Business Development E&C.
Analyze and identify program and business risks. Work with R&D/ LRL leadership and functional areas to develop and implement monitoring program and compliance assessment activities. Follow up appropriately with root cause analysis and meaningful corrective actions/preventive actions.
Effectively communicate the ‘state of control’ to the leadership teams. Foster open communication and feedback from leadership teams to ensure suggested controls are a good fit for the remit and mitigation of R&D risks.
Drive effective implementation of the compliance program through the business.
Accountable for follow up on audit findings as appropriate to the E&C function.
Ensure R&D Ethics and Compliance needs are reflected in the support plans of corporately based E&C groups (such as Central Operations, Policy Center of Excellence, etc.)
Ensure an open and collaborative environment that promotes teamwork, open communication, and collaborative interactions among team members and with the broader R&D/LRL site leads.
Provide input into development of Corporate Compliance Policies and Procedures that reflect the needs and remit of R&D topics.
Ensure business processes and operational procedures are consistent with Global Policies and Standards.
Provide compliance support as needed for investigations of non-compliant activities and appropriate corrective action/disciplinary steps.
5+ years of experience in global research & development, clinical development, medical affairs or closely related area.
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
Experience working in highly matrixed organizations - across therapeutic areas, business units, functions and geographies
Communicate effectively as well as ability to translate ambiguity and complexity into a meaningful, applicative framework.
Demonstrated ability to influence without authority at all levels of leadership in the organization and to network internally and externally.
High level of professional maturity and sensitivity to confidentiality.
Strong leadership skills (people development, critical thinking, results oriented, etc.), including a strong reputation for integrity and sound objectivity.
Willingness to challenge and speak up and ability to reach solutions quickly
Position requires some domestic and international travel. Domestic travel will include to Indianapolis, and R&D sites in the US.
No documented compliance violations within the last 12 months (internal applicants).
Lilly currently anticipates that the base salary for this position could range from between $138,750 to $203,500 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience. 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).Of course, the compensation described above is subject to change and could be higher or lower than the range described above. Further, 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.
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 ( LillyRecruitingCompliance@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.