Associate Director - Trial Capabilities, Budgets & Contracts

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.
At Eli Lilly Cork, 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 45,000 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 patients 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. In-house 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. 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 the Associate Director, Trial Capabilities, Budgets & Contracts role is to lead clinical trial capabilities in support of clinical development. This includes leading teams in the execution of clinical trial budgets and contracts activities across the EMEA countries/region enabling patient enrolment readiness in the portfolio of clinical trials to target across the countries/region. The Associate Director / Director is accountable for budgets and contracts activities during site activation, maintenance and close out utilizing deep technical expertise and understanding of cross functional dependencies to drive delivery of business objectives. The Associate Director / Director works closely with functional partners and the global study teams ensuring accurate planning, prioritisation to meet portfolio needs. The Associate Director / Director anticipates and mitigates risks and ensures timely issue resolution. The Trial Capabilities Associate Director / Director provides leadership, direction and technical support in budgets and contracts activities to the Trial Capabilities Teams focusing on results and driving efficiency to achieve goals and objectives.
Primary Responsibilities Clinical Trial LeadershipLead and coordinate the execution of clinical trial budgets and contracts activities across country/region for high priority (Game Changer and Potential Game Changer) and complex trials representing the geographical complexity.Leverage deep expertise in regional trial execution to support Trial Capabilities representation in global, cross-functional clinical trial forums.Anticipate and mitigate risks and resolve complex and critical risks/issues to enable timely delivery of Trial Capabilities commitments across countries/region with special attention to Payments.Influence execution based on knowledge of regulations and applying the learnings from regulatory/ERB feedback gained from other programs.Support implementation and drive compliance to value added projects e.g., Vault Clinical Study Start-Up (SSU), electronic Trial Master File (eTMF), Shared Investigator Platform (SIP) to ensure impactful portfolio support and management.Lead and support global functional projects related to integration of processes and automation to drive global solutions across geographic regions partnering with Trial Capabilities Leadership and global clinical system and information technology functions.Provide input into the design and implementation of value-added solutions that will enhance Trial Capabilities effectiveness and productivity and enable acceleration of enrollment readiness.Contribute scientific and disease expertise and utilize strategic knowledge of Lilly's portfolio and priorities to lead country prioritization of work and anticipate future needs for Trial Capabilities.Recognized as an expert in local/global regulations, laws, and guidance (e.g., ICH), and assess the impact on local and global processes ensuring internal processes and procedures reflect and comply with country requirements.Lead and consult on internal audits and external inspections as well as supporting institutions/investigative sites in inspection readiness initiatives.Business Management and External InfluenceDrive and/or support discussions with regulatory bodies / ERBs providing rational for specific budgets and contracts elements and ICF language.Engage with regulatory bodies and ERB to influence and challenge internal and external factors shaping clinical trial execution.Lead and share technical and operational expertise across the Global Trial Capabilities organisation (>400 people) as well as across Clinical Design, Delivery and Analytics (CDDA).Lead Trial Capabilities team to effectively manage budgets and contracts activities during study start-up.Proactively identify process improvement opportunities and collaborate with the CDDA functions to re-design more effective and efficient processes.Identify and develop robust mechanisms to retain a scientific, technical, and operationally capable Trial Capabilities workforce skilled and knowledgeable in clinical development.Effectively manage an agile organization that continuously meets the needs of a changing portfolio.Acts as a subject matter expert coaching and mentoring individuals within Trial Capabilities and CDDA organization.Develop an organizational culture that fosters inclusion and innovation and demonstrates judgment-based decision making in clinical delivery.Understand and comply with procurements, legal, data privacy and financial requirements and procedures.Organizational LeadershipIdentify and ensure shared learning across the clinical organization and with other functional groups within CDDA.Build capabilities in the function through the development and improvement of processes, tools and training.Enable a culture of continuous improvement to drive efficiency through process improvement, people skills, and shared learning.Manage staff compliance to local regulations and guidance, Lilly Medical policies and procedures, and Good Clinical Practice (GCP).People Management and DevelopmentRecruit, develop, and retain an operationally capable workforce skilled and knowledgeable in clinical development.Effectively manage an agile organization that continuously meets the needs of a changing portfolio.Develop an organizational culture that fosters inclusion and innovation and demonstrates judgment-based decision making in clinical delivery.Minimum Qualification Requirements: Bachelor's degree preferably in a scientific or health related fieldExperience in clinical practice, clinical research or pharmaceutical medicine, and the drug development process.At least six (6) years clinical trial budgets and contracts leadership experience or relevant experience.Other Information/Additional Preferences: Deep therapeutic expertise and knowledge of clinical research.Previous supervisory experience.Demonstrated leadership behaviours with ability to accept challenges, seek opportunities to remove barriers, lead in areas of uncertainty and influence without authority.Understanding of the overall clinical development paradigm and project management processes and skills.Proficiency in country/regional regulatory and legal guidelines/requirements.Appreciation of / experience in compliance-driven environment.Strong communication, negotiation, and problem-solving skills.Strong self-management and organizational skills.Experience in coaching and mentoring others.Language Capabilities – English (read, write, conversation) other language(s) a bonus.Demonstrated judgment-based decision and decision-making ability.Strong teamwork and interpersonal skills including ability to work across countries and cultures.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.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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