Sr Director, Global Patient Safety - Medical Review

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.

Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’

wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.

Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, embRACE, LGBTQ+ & Ally and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.

Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself

Purpose

The purpose of this role is to provide leadership for GPS Medical Review. In particular, leadership will be provided through direct technical and administrative leadership of a global team of therapeutically aligned Medical Review physicians and scientists. They will work in close collaboration with and report to the Senior Director/Executive Director – GPS Medical Review and will collaborate with leaders globally responsible for Medical Review and Case Management.  

Primary 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 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 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.

Enterprise Leadership

• 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 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 responsibili