Associate Director/Director – Risk Management Scientist Global Patient Safety Full-time

Risk Management Technical Expertise

Provide strategic guidance to product-specific cross-functional teams on optimal risk minimization strategies

Support all risk management and risk minimization activities for assigned products including development and maintenance of RMPs, ARMMs, and REMs ensuring configuration with overall product strategy.

Facilitate product-specific results to meet quality standards and timelines

Provide risk minimization resources, tools, and expertise as needed to support the assigned product portfolio including support for risk minimization efficiency/assessment reports and additional PV activities.

Collaborate with other GPS functions for tracking and reporting on product-specific metrics related to risk minimization efficiency and compliance

Lead as subject matter expert responsible for Risk Management strategies across therapeutic areas and globally in collaboration with cross-functional teams including product development teams engage in key product team meetings and decision forums.

Influence product teams in strategic decision-making regarding risk management approaches throughout the product lifecycle

Guide clinical development teams on benefit-risk and risk management considerations during product development, including providing support on identifying benefit-risk assessment frameworks and visualization tools.

Lead and support product-specific regulatory interactions related to risk management (e.g., health authority meetings, responses to regulatory questions).

Drive solutions leading to consistency in tracking, documenting and presenting product-specific metrics and key performance indicators.

Maintain and apply awareness of the global regulatory environment, including new regulatory guidance, product-specific risk management and risk minimization activities.

Lead the coordination of large, multi-component, cross-functional product-specific activities with affiliates, partners, and third-party organizations (TPOs) in the design and implementation of RMPs and risk minimization activities.

Proactively identify risks to product-specific risk management activities along with developing, delivering and communicating contingency plans to key collaborators.

Support the monitoring and tracking of the implementation and execution of product-specific Risk Management activities globally in conjunction with the GPS quality group.

Identify and champion opportunities for risk management strategy optimization based on accumulating product data.

Identify and communicate dependencies and interdependencies across assigned product portfolio

Establish and maintain regular communication with key GPS and business unit personnel for the assigned product portfolio.

Advise and guide on product-specific risk management activities by collaboration with internal cross-functional customers, including medical affairs, regulatory, clinical development, commercial and regional/local affiliates, and external TPOs involved in the implementation of Risk Management projects.

Collaborate with GPS pharmacoepidemiology on product-specific observational studies that support risk management objectives.

Collaborate with other GPS functions on the oversight of post-marketing safety activities related to assigned products including risk minimization efficiency reports, REMS assessment reports, DSURs, PBRERs/PSURs, and ARMM efficiency reports.

Perform as SME for Health Authority inspections and audits for assigned products within scope of risk management.

Ensure utilization and consistency of detailed GPS processes and quality systems.

Mentor and develop junior team members on technical and regulatory aspects of risk management and risk minimization through product work.

Enterprise Leadership

Communicate effectively with internal and external partners to align priorities and drive informed decision-making.

Support and lead maintenance of processes and tools to effectively communicate product-specific risk management information to all key partners, including senior management, governance committees, product team members, functions, business units, partners, and affiliates.

Represent Lilly on selected external working groups related to risk management and benefit-risk assessment

Influence developing initiatives (policies, practices, guidance, and regulations) at FDA, EMA, and other regulatory agencies

Champion guidelines and lessons learned from product experience to improve organizational capabilities

Understand and Support the EU QPPV Role

Demonstrate clear understanding of the roles and responsibilities of the EU Qualified Person and associated regulatory expectations.

Provide support to enable the EU Qualified Person to fulfill their legal obligations.

Minimum Qualification:

Bachelor's degree in a scientific or healthcare related field (e.g., Pharmacy, Nursing, Life Sciences).

5 years of experience in Clinical Development in scientific, health care for pharmaceutical industry.

2 years of experience in patient safety

Preferred Qualifications:

Advanced degree or equivalent strongly preferred with 3+ years experience in Clinical Development in scientific, health care for pharmaceutical industry.

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 for further assistance.

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.

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

$115,500 – $169,400

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.