GPS Case Management Medical Review Therapeutic Area Leader

Lilly • Indianapolis, IN

3d • $225,000 - $330,000 • Onsite

About The Position

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Requirements

• Medical Doctor or Doctor of Osteopathy.
• Must be board eligible or certified in appropriate specialty/subspecialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring.
• US trained physicians must have achieved board eligibility or certification.
• Foreign medical graduates (in US based jobs) who are not US board eligible or certified may be hired directly for employment in the US at the discretion of the Chief Medical Officer.
• Non-US trained physicians must have completed education and training at a medical school that meets the minimum requirements substantially equivalent to the requirements of medical schools accredited by the Liaison Committee on Medical Education (LCME).
• Fluent in English with highly effective written and verbal communication skills.
• Strong clinical/diagnostic skills.
• Excellent interpersonal, organizational and negotiation skills.
• Ability to work on multiple projects and function effectively in a fast-paced matrixed environment.
• Ability to prioritize tasks and shift priorities rapidly to meet tight deadlines
• Ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.
• Excellent teamwork skills.

Nice To Haves

• 5 years of clinical development or pharmacovigilance experience preferred.
• Knowledge of drug development process.
• Willing to engage in domestic and international travel to the degree appropriate to support the business of the team.

Responsibilities

• Supervise Case Management Medical Review personnel within the therapeutic area across the global team, including physicians and scientists.
• Build deep regulatory and technical expertise through recruitment, development, and retention of staff.
• Facilitate, train and mentor Case Management Medical Reviewers in the responsibilities of the role.
• Provide feedback and coaching, support short and long-term development plans, and ensure appropriate individual recognition.
• Oversee the medical evaluation of safety of Individual Case Safety Reports for all assigned compounds across their life cycle to inform the safety profile of the therapeutic area portfolio.
• Develop, maintain, and share technical expertise and medical knowledge in the therapeutic area.
• Provide strong global medical leadership that influences scientific and process improvements and drive change within the organization.
• Lead and participate in process improvement and innovation projects to support the safety of all assigned compounds.
• Participate in the development and implementation of the functional strategic plan for Case Management Medical Review.
• Manage resources to meet business objectives and future needs within the therapeutic area in collaboration with leaders across the global team.
• Collaborate cross-functionally to ensure alignment of goals and deliverables, readjusting as business needs dictate.
• Partner closely with global GPS partners for efficient resource forecasting, planning, and utilization to meet business objectives.
• Lead actions and collaborate with GPS teams to ensure appropriate interaction, communication, and high-quality medical evaluation of safety within the therapeutic area.
• Act as a Lilly Case Management Medical Review representative for both internal and external customers, interacting as described in corporate guidelines and policies.
• Build strong relationships with key customers, representing and championing the role of safety in the organization.
• Collaborate with Affiliates, Business Units, and Clinical Development teams regarding areas of relevant medical review expertise and responsibility.
• Lead actions required to manage or clarify a safety issue in collaboration with the responsible global teams.
• Understand the roles and responsibilities of the EU qualified person (QP) and ensure support to the fulfillment of QP’s legal responsibilities is provided when required.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• 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
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Ph.D. or professional degree