Sr. Director-Counsel-Immunology

at  Lilly

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.
It is an exciting time to be a part of the Lilly organization! Our legal team is growing, and we’re looking for a skilled attorney to support our Immunology business unit. Do you have experience in early phase clinical trials? This role will have the exciting responsibility of supporting Lilly Immunology, but would also have exposure to other therapeutic areas, including oncology. Consider joining and being part of the Lilly story!

As counsel for Lilly Immunology, you will provide global strategic legal advice and practical counsel to the global product development and U.S. brand teams. As counsel responsible for oral integrin development, you will embed with the team developing a lead oral integrin molecule for inflammatory bowel disease and potentially other diseases. 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:

• Execution of currently running Phase 2b clinical trial within acquired subsidiary.
• Communication plans for Phase 2b clinical trial disclosures.
• Transition of development efforts from acquired subsidiary to Lilly.
• Phase 3 development planning (patient reported outcome plans, key market regulatory needs, CT material sourcing, drug substance commercial format, pediatric plans).
• Regulatory strategies (end of Ph2, global regulatory advice, expedited pathways, etc.).
• Commercial strategy development (innovation readiness activities, asset profiling, market research, payer insights, generic naming convention, product naming, etc.).
• NILEX and combination therapy development planning.

In addition, this role may provide legal advice related to the commercialization of legacy assets in the Lilly Immunology portfolio which will be marketed solely through non-personal channels via the Lilly Greenhouse.
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 will advise on legal strategy to a fast-paced and evolving business. The attorney must demonstrate an ability to work collaboratively within Lilly Legal and with business stakeholders. This position reports to the AVP - Assistant General Counsel, Lilly Immunology.

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

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 raised 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
• Contributing 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

As counsel for Lilly Immunology, you will provide global strategic legal advice and practical counsel to the global product development and U.S. brand teams. As counsel responsible for oral integrin development, you will embed with the team developing a lead oral integrin molecule for inflammatory bowel disease and potentially other diseases. 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:

• Execution of currently running Phase 2b clinical trial within acquired subsidiary.
• Communication plans for Phase 2b clinical trial disclosures.
• Transition of development efforts from acquired subsidiary to Lilly.
• Phase 3 development planning (patient reported outcome plans, key market regulatory needs, CT material sourcing, drug substance commercial format, pediatric plans).
• Regulatory strategies (end of Ph2, global regulatory advice, expedited pathways, etc.).
• Commercial strategy development (innovation readiness activities, asset profiling, market research, payer insights, generic naming convention, product naming, etc.).
• NILEX and combination therapy development planning