Senior Director Global Patient Safety - Medical

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.

The purpose of the Sr Director, 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 Sr Director, GPS Medical is accountable for collecting, evaluating, and managing the safety information of specific Lilly investigational and marketed products worldwide. The Sr Director is accountable for ensuring compliance with regulations globally, performing proactive safety monitoring, and making recommendations for managing any potential safety issues. The Sr Director is also responsible for the review of documents that will be submitted to regulatory authorities and 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

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

Support of GPS Medical Activities

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

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 GPS Medical physicians/clinical research scientists and global development and brand teams 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 all assigned development compounds and approved products, as appropriate. Provide Global Patient Safety expertise to internal customers (e.g., regulatory, discovery and clinical research, business units).

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

Understanding and Support of the QPPV role

• Understand 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:  

• 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 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

Other Information/Additional Preferences:  

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

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 proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

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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