Description:
The purpose of the role of Associate Director RDMC Cork, Global Patient Safety Pharmacoepidemiology (GPS PE) is to provide strategic and personnel leadership to the GPS organization in Cork, more specifically GPS PE for the effective execution of pharmacoepidemiologic and related risk management activities. The Associate Director in conjunction with the GPS PE Leadership Team will optimize the PE capacity to support of risk assessment/management activities for assigned Lilly products. The Associate Director will also work in close collaboration with global leaders responsible for relevant function(s) and will ensure the GPS PE Team’s alignment to and integration with the global business needs and strategy. The Associate Director will provide tactical direction to ensure the GPS PE team at Cork demonstrates strong technical capabilities, maintains a high level of compliance (to both internal and external global regulatory expectations) and continues to evolve and grow to meet the organizational needs and external environment.
Functional Leadership & People Management
- Oversee the implementation and maintenance of the PE expertise and activities to support risk assessment/management activities for assigned products within Lilly’s portfolio.
- Lead, motivate and work with team members to provide them with appropriate objectives/personal development plans/career opportunities.
- Ensure optimal resource and workload management/prioritization.
- Collaborate with colleagues to ensure a coordinated and consistent approach to operational issues and staff management across teams, functions and sites.
- Recruit, develop, and retain a strategic and talented workforce with strong epidemiology expertise and pharmacovigilance skills to deliver high performance in their area of work and the potential to learn and evolve for the current and future needs of the organization.
- Coach and mentor direct reports (supervisors and talented employees) to build strong leadership and technical capabilities for future organizational needs.
- Partner with global GPS partners for efficiency, quality improvements, and process/technology changes as required.
Enterprise Leadership
- Collaborate within GPS and cross-functional leadership for business needs, learning and knowledge sharing.
- Drive efficiency and continuous improvement in processes and technology by motivating, supporting and leading improvement initiatives within the team and cross-functionally.
- Maintain awareness of the external environment through benchmarking, external collaborations, contacts and professional organization involvement, and represent GPS PE at appropriate internal and external events as relevant.
- Drive strong partnership and engage with Cork Site Leadership, RDMC and other functional groups to support site strategy and effectiveness.
Quality & Compliance Management
- Ensure organizational compliance with relevant regulations, policies, procedures, and training requirements.
- Ensure appropriate metrics and systems are in place to monitor quality and compliance activities.
- Lead or contribute to business process improvement initiatives.
- Stay updated on changing global regulatory environment and proactively adapt the organization’s policies and practices.
- Support internal and external inspections through resource coordination, document collection, trained personnel, and direct participation.
Company Presence / Influence Outside of GPS PE Organization
- Provide PE and risk management expertise to internal and external customers (e.g. Business Units, Affiliates, RWE, Alliance Partners) as appropriate.
- Represent Lilly in relevant external groups/initiatives, including scientific, regulatory, and pharmacovigilance forums.
- Build effective relationships and collaborations that will facilitate external influence.
Understand the roles and responsibilities of the EU-qualified person (QP) and support the fulfilment of QP’s legal responsibilities when required.
Minimum Qualifications
- Master’s degree in a health-related field (preferably PhD in Epidemiology or related Public Health field) and 3+ years of experience in scientific research or the pharmaceutical industry.
- Management or Supervisory experience (2 years or more) with demonstrated effective leadership and interpersonal skills.
- Expertise in the design, conduct, analysis, interpretation, and communication of scientific research and/or observational studies
- Ability to develop and implement strategies across people, processes, organizations, and technology based on data and sound judgment.
- Ability to work in a multicultural virtual global environment and partner across matrix organizations to collaborate with peers locally and globally.
- Strong ability to influence across boundaries, with strong business partner and customer focus.
- Strong communication skills, both verbal and written (in English).
- Availability to travel when required.