GPS Medical Review Therapeutic Area Senior Director

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.

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.

Responsibilities:

Leadership in Medical Review

• Supervise 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 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 for personnel 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.
• Lead and participate in development and improvement of operational systems and processes in support of Medical Review and Safety Management.
• Participate in the development and implementation of the functional strategic plan for Medical Review
• Manage resources to meet business objectives and future needs within the therapeutic area in collaboration with leaders across the global team.
• Support Medical Review and SMRD business planning and management of targets and staffing.
• 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.

Enterprise Leadership

• Lead actions and collaborate with GPS Medical & Safety Science teams to ensure appropriate interaction and communication to ensure high quality medical evaluation of safety within the therapeutic area.
• Act as a Lilly GPS 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.
• Liaise with other Regional Centers to ensure global consistency.
• Represent MR and/or SMRD on appropriate committees.
• Provide medical support for GPS activities as appropriate.

Assurance of Drug Safety Regulatory Compliance

• Monitor of medical review compliance and productivity within the therapeutic area.
• Ensure effective training is provided to staff in advance of assuming job responsibilities.
• Ensure appropriate quality systems are in place.
• Understand global regulatory environment and proactively adapt policies, procedures and practices as required.
• Support external and internal inspections through direct participation and resource coordination.
• Maintain broad knowledge of safety reporting requirements, pharmacovigilance requirements, and industry practices; review, understand, and evaluate regulatory changes and proactively adapt processes to maintain compliance with regulation

Minimum Qualification/Requirements:

• Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in a medical specialty 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.
• Physicians trained outside the US 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 PLA: Medical Licensing Information  and Medical Education | MBC

Other Information/Additional Preferences:

• 2+ years of prior people management experience.
• Prior experience in pharmacovigilance or interconnected areas (e.g., Medical Affairs, Drug Safety Quality, Clinical, etc.).
• Demonstrated robust leadership, interpersonal and management skills.
• Ability to work in a multicultural virtual global environment.
• Robust communication skills, both verbal and written (in English).
• Ability to understand and interpret clinical studies and health scientific data.
• Essential computer skills (e.g., office suite and internet browsers).
• Availability to travel when required.

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

$225,000 - $330,000

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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