Associate Director, Clinical Systems, Quality And Process

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 1,600 employees across 38 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, subsidized 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, Age & Culture, LGBTQ+ 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.
At Lilly, we serve an extraordinary purpose. We make a difference for people around the global 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.
Bring your skills and talents to Lilly and our Pharmaceutical Project Management team, where you'll have the opportunity to make an impact on the lives of patients around the globe.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself.
The purpose of the Associate Director role is to provide operational leadership to support exploratory and biopharmaceutics clinical development. The role works across the organization including with functional and organizational partner groups to deliver knowledge, expertise, standard templates, and technology to identify various clinical development scenarios and provide functional expertise to ensure successes of portfolio delivery .
This role continually provides expertise in process and methodologies of EMP whilst looking for advancements and improvements.
Key areas of responsibility of the role include:
a) leading activities supporting study development and execution
b) cross-functional systems and processes
c) systems, metrics and reporting.
In addition to knowledge of ICH and quality guidelines needed for successful delivery of the portfolio and clinical trials, the Associate Director/Director possesses the business acumen, process knowledge, and influence required to lead in process and quality improvement efforts.
The Associate Director/Director will seek knowledge from internal and external sources and use this information to drive strategic discussions with clinical and functional counterparts make recommendations to gain efficiencies and speed to shape development plans and continuous improvement opportunities.
Primary Responsibilities:
This job description is intended to provide a general overview of the job requirements. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position. Study Development and Execution Support:
Establish networks with other key support areas to efficiently and effectively support exploratory and biopharmaceutics clinical studies.The team will support study development by owning updates to corporate systems and processes eg CT Registry, Vault Clinical; trial and compound level documentation management eg eTMF and the contracting elements for a study.Provide leadership in business interactions with TPO partners; helping to execute the exploratory and biopharmaceutics clinical development portfolio. Lead and partner in the issue escalation and relationship management processes,vendor and clinical research unit assessments as appropriate.Maintain awareness of regulatory issues and trends relevant to assigned portfolio.Cross-Functional Systems and Processes:
Provide leadership in business processes supporting early phase development.Established expertise on key business systems that support exploratory and biopharmaceutics clinical development.Review of established procedures across multiple subject areas, dependent on the change agendas to be evaluated and prioritized. Contribute to the overall strategic direction of cross-functional systems and processDraw on deep exploratory and biopharmaceutics clinical development knowledge and process expertise to review processes and when necessary sponsor improvement intiatives to increase business efficiency and value.Ensure cross-functional process alignment internally and externally where appropriateAct as a key resource to internal governance committees regarding processes utilized in the exploratory and biopharmaceutics clinical developmentEnsure optimal network with the Quality, Clinical Information and Process Automation, and L&D organizations is established in order to guarantee processes deliver on Quality and Regulatory compliance requirementsSystems, Metrics and Reporting:
Drive definition of metrics or measures to quantify exploratory and biopharmaceutics clinical development portfolio deliverables and assess process effectivenessDevelop a metrics / measures and evaluation strategy for the organization. Establish and operationalize the processes to support this strategy e.g. scorecard generationDrive identification and development of emerging technologies to support the advancement of medicines to the clinic. e.g. Artificial Intelligence toolsMonitor implementation progress of implemented systems and/or recommend corrective actions, if needed.People Management and Employee Development:
Attract, retain and develop a diverse workforce.Model behaviors and establish an environment where performance and results are valued, and where individuals are learning and growing developmentally.Seek opportunities to reward and recognize individuals and teams.Provide supportive environment for staff to explore innovative solutions to business problems and implement strategic and tactical decisions.Contribute to succession planning, talent assessment and performance/promotion processes. Ensure high talent staff are appropriately rewarded and developed.Coach and mentor department personnel, and as needed, cross-functional members, in order to affect development and growth of all team members.Minimum Qualification Requirements:
Bachelor's degree in a science related field from an accredited college or university; or equivalent qualifications/experience (3-years' experience in the pharmaceutical industry with direct experience of managing clinical studies, ideally in exploratory and biopharmaceutics clinical development (5+ year preferred)).Strong knowledge of regulations and guidelines that apply to the conduct of clinical trials.Demonstrated project management and time management skills.Demonstrated ability to work effectively cross-culturally and in a virtual work environment.Demonstrated ability to influence both internal and external environments appropriately and forge strong working relationships.Strong organizational and interpersonal skills and the ability to be flexible in varying environments and with multiple customer groups.Strong verbal reasoning, attention to detail, critical thinking, problem solving, and analytical abilities.Proven experience of coaching and mentoring others.Ability to travel (up to 10% expected – varies dependent on responsibilities)Other Information/Additional Preferences:
Advanced scientific degreeDirect supervisory experienceDeep expertise in one or more clinical research functions (clinical operations, sourcing, data sciences)Vendor management and contracting experience.Exploratory and biopharmaceutics clinical development, quality and Six Sigma experience preferred.Demonstrated high-level, end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentations and templates).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.
Lillydoes 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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