Associate Vice President - Global Patient Safety, Immunology

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.

Immunology Associate Vice President/Vice President, GPS Medical

Organization Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Purpose:

The purpose of the Immunology Associate Vice President, GPS Medical role is to be responsible for assessing the safety of Lilly products and communicating safety issues to customers and regulators to maximize the safe use of Lilly products in the best interest of patients, health care professionals, and the corporation in specific therapeutic areas. This role requires strong leadership, guidance, and management of a global group of therapeutically aligned physicians and clinical research scientists. The Immunology Associate VP is accountable for collecting, evaluating, and managing the safety information of all Lilly investigational and marketed products worldwide. The Immunology Associate VP is accountable for ensuring compliance with regulations globally, performing proactive safety monitoring, and making recommendations for managing any potential safety issues. The role is also accountable for the core safety information (CSI) within the core data sheet (CDS) that are approved by the Global Patient Labeling Committee, the review of documents that will be submitted to regulatory authorities, participation in safety meetings, and mentoring of employees, as required.

Primary Responsibilities:

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Manage people effectively

• Facilitate regular meetings with feedback and developmental discussions; assist in development of career plans; and ensure good succession planning.
• Recruit and retain clinical research associates, clinical research scientists and clinical safety physicians to support the safety assessment and communication of products in GPS Medical.

Support of GPS Medical Activities

• Review and approve all safety communications to customers and regulatory authorities regarding safety issues for all products in the therapeutic area.
• Drive implementation of new processes and roles and responsibilities.
• Build relationships with applicable groups in medical and marketing functions as well as designated affiliates including Japan.
• Responsible for development and/or implementation of processes to support the safety of all products in the therapeutic area.

Develop, maintain and share technical expertise and medical knowledge personally and for the GPS Medical personnel in the therapeutic area

• Provide global medical leadership and input into all aspects of safety of assigned compounds and products including surveillance programs and risk management planning.
• Build collaborative working relationships with other Patient Safety Medical physicians and development and brand teams medical globally to ensure full cooperation and high-quality medical evaluation of safety data for global regulatory purposes.

Represent GPS Medical or product on appropriate committees/product development and brand teams. Provide medical support for Global Patient Safety Medical activities and reports within the therapeutic area, as appropriate. Provide Global Patient Safety expertise to internal customers (e.g., regulatory, discovery and clinical research, business units).

• Maintain compliance with Lilly Red Book and corporate policies, Lilly Research Laboratories and Global Patient Safety curriculum map.
• Drive safety related publications and presentations.
• Maintain compliance with LRL & Global Patient Safety curriculum map; develop Global Patient Safety expertise through discussion and training programs.

Understanding and Support of the QPPV role

• Understanding the roles and responsibilities of the EU Qualified Person.
• Ensure support is provided to enable the Qualified Person to fulfill all the Qualified Person legal responsibilities.

Minimum Qualification Requirements:

• Non-U.S. trained physicians must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME). For the recognized list of foreign medical schools and the disapproved list, see http://www.in.gov/pla/2799.htm
• U.S. trained physicians must have achieved board eligibility or certification.
• Foreign medical graduates in U.S. based jobs, who are not U.S. board eligible or certified may be hired directly for employment in the U.S. at the discretion of the Chief Medical Officer.
• 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.

Other Information/Additional Preferences:

• Ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.
• Willing to engage in domestic and international travel to the degree appropriate to support the business of the team.
• Fluent in English; both written and verbal communications
• Excellent interpersonal, organizational and negotiation skills
• Clinical research or pharmaceutical medicine experience preferred
• Knowledge of drug development process
• Excellent teamwork skills.

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As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).

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