Sr. Director-Counsel-Lilly Oncology Legal - Eli Lilly and Company

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.

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

Lilly Oncology – Legal Counsel, Hematology

As counsel for Lilly Oncology, you will provide global strategic legal advice and practical counsel to the global product development and U.S. brand teams. As counsel responsible for hematology development and commercialization, you will embed with the team developing and commercializing a medicine used to treat those with certain hematological diseases and potentially other diseases. This role will also provide counsel to a team commercializing a medicine used to treat a targeted form of thyroid and lung cancer. Principal objectives will be to provide comprehensive legal advice and liaise with regional and specialty legal colleagues in order to counsel business partners on various legal matters related to:

• Regulatory strategies (accelerated approval conversion, global regulatory advice, NILEX strategies, etc.).
• Commercial strategy development (data analysis/patient identification, non-personal promotional media channels, social media engagement, pathway engagement, genomic testing advocacy).

These legal matters may include FDA and global regulatory clinical development, medical affairs, product manufacture and distribution, reimbursement, the Anti-kickback Statute and its safe harbors, the False Claims Act, antitrust, commercial law, and business transactions. In this role, you must be able to provide strategic legal advice to a fast-paced and evolving business. You will demonstrate an ability to work collaboratively within Lilly Legal and business collaborators. This position reports to the AVP - Assistant General Counsel, Lilly Immunology.

Your activities in this role may include the following:

• Evaluating scientific and investment communications for integrity, context and applicability of PhRMA principles for communicating truthful and non-misleading scientific information
• Reviewing regulatory briefing documents (in collaboration with Regulatory Legal) to enhance advocacy of business objectives
• Serve as point of contact for escalated clinical trial issues (recruitment tactics, subject injury, distribution concerns, investigator disputes, etc.) and liaise with Regulatory Legal and Litigation as appropriate
• Providing legal counsel and education on FDA labeling and promotional matters (e.g. global BRIX assessment of claims strategy, MLR claims and tactic escalation for commercialized assets, and scenario planning for alternate labeling outcomes and means to communicate data pursuant to other frameworks for new indications/approvals (e.g. “consistent with label”, etc.))
• Collaborating with sales and marketing colleagues to advise on patient support and other programs consistent with healthcare fraud and abuse laws
• Educating on potential legal implications of proposed marketing programs
• Participating as a core member of leadership teams responsible for US brands and/or global product strategies
• Drafting, reviewing and otherwise commenting on various contracts related to your product portfolio, including collaborative research agreements, research grants and independent investigator research (in collaboration with Regulatory Legal and TCOE Legal)
• Advising on data disclosures following clinical development achievements via press release and US and international medical congresses aligned with laws and regulations

Basic Qualifications

• JD degree and currently admitted to the bar in at least one U.S. state
• Candidate must be eligible to be admitted to the bar in Indiana under Indiana Admissions Rules
• Minimum of 5 years of relevant legal experience either practicing as a member of a law firm in a relevant area of law or practicing in house at a pharmaceutical or biotechnology company’s law department or a combination of the two.

Additional Skills/Preferences

• Previous experience as a global product attorney and/or at a pharmaceutical or biotechnology company preferred.
• Experience working in a nationally-recognized law practice
• Knowledge and understanding of pharmaceutical laws and regulations as generally practiced by multinational pharmaceutical manufacturers
• Familiarity with clinical trials, clinical collaborations, anti-kickback statute, competition law, pricing, reimbursement and access issues as they pertain to the pharmaceutical industry
• Ability to handle multiple priorities in a dynamic and evolving environment
• Excellent oral and written communication skills with a shown ability to present complex information accurately and concisely to influence others at all levels of management
• Ability to assess and help business colleagues handle risks in a highly regulated environment
• Strong analytical skills
• Proven learning agility
• Strong background demonstrating ability to influence people and outcomes
• Committed to teamwork and collaboration

Additional Information

• Some travel required (US and limited international)

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 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.

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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