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 41,000 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 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, 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, 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.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself
The Clinical Development Trial Lead (CDTL), Associate Director independently leads the cross-functional study team in the development and execution of complex clinical trials and is accountable both regionally and globally to deliver clinical milestones on trial(s) with quality, on time, and within scope and budget. The CDTL Associate Director/Director consistently demonstrates independent leadership, influence when working with study teams, management, and business partners, and prospective identification of potential issues and resolution thereof.
Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. 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.

PROJECT MANAGEMENT, AND REGIONAL OPERATIONAL KNOWLEDGE

• Broader responsibilities at Therapeutic Area/ Molecule/Indication level (e.g. attending relative Critical Chain network builds, providing input on strategy).
• Use project management skills, processes, and tools to develop and execute local, regional, and/or global clinical trials (CT) as described:
• Scope - Understand the scope of work required to complete the clinical trial successfully. Monitor the status and make adjustments and changes (per change control process) as needed to meet the deliverables of the trial.
• Timeline – Develop and track global trial enrollment plan by gaining alignment and integrating inputs across functions and geographies. Provide consultation and guidance to CDTLs on their Integrated Plans.
• Risk - Assess, identify and monitor trial-level risks. Incorporate scientific knowledge, trial process, and regional expertise to create one integrated trial-level risk mitigation and contingency plan.
• Budget - Understand the cross-functional, trial-level budget components. Create and monitor the budget grants and non-grants, and assumptions using financial tracking tools. Routinely network with appropriate business partners on trial-level budget status and changes. Function as point of contact for other CDTLs on their clinical team as needed regarding budget items.
• Lead, influence and project manage large, complex studies and/or multiple smaller studies.
• Partner with other organizations to coordinate and actively participate in Investigator Study Specific Training (ISSTs)/ Affiliate Study Training (ASTs).
• Independently drive and influence local, regional and global, cross-functional study team throughout study implementation, execution and closure empowering them to meet the clinical trial deliverables, including proactive issue management, contingency planning and issue resolution. Drive to solutions across the molecule/program.
• Be accountable for trial/regional/program/molecule enrollment strategy and execution from country allocation through Last Patient Entered Treatment (LPET)
• Partner with the Regional Operations to achieve regional enrollment goals.
• Foster relationships and serve as a single point of contact and central owner for trial communication, to and from the CDDA Organization, Regional Clinical Operations, and Third-Party Organizations (TPOs). Effectively manage and influence upward.
• Anticipate and resolve complex and key technical operational or business problems with cross-functional study team (including vendors, affiliates/ regions, global team members, and other business partners) with little/ no need for direct management support. Evaluate and determine issues that require escalation.
• Identify and assist in developing continuous improvement activities based on important trends such as industry, regulatory, new technology, etc.
• Leverage expertise to make timely decisions for ambiguous and complex situations. Uphold a consistent, solution-oriented approach to conducting daily business.
• Demonstrate credibility and influence to enable teams and multiple business partners, both internally and externally, to make effective and timely decisions.
• Manage TPO (third party organization) qualification process, selection, and oversight.
• Serve as the CRO (Clinical Research Organization) clinical development point of contact for outsourced and fully outsourced trial execution. Ensure CRO delivery of project milestones.

MINIMUM QUALIFICATION REQUIREMENTS:

• Bachelors or University degree (scientific or health-related field preferred) and 5 years clinical research experience or relevant experience in a scientific or health-related field; or an advanced degree.

Highly Desired Skills:

• Applied knowledge of project management methodology, processes and tools
• Demonstrated ability to lead and work effectively cross-culturally with global colleagues and with TPOs
• Be recognized as a leader with demonstrated ability to coach others in process expertise.
• Embrace strategic organizational changes and lead others effectively through these, exhibiting flexibility to adjust quickly and effectively to frequent change and altered priorities
• Ability to influence without authority
• Previous experience working in cross-functional teams/ projects and/or ability to establish and manage relationships
• Effective and influential communication, self-management, and organizational skills
• Demonstrated ability to manage complex situations through problem-solving, critical thinking and navigating ambiguity

Other Information/Additional Preferences:

• Minimum of 5 years clinical trial experience with a strong working knowledge of the clinical research process
• Prior clinical trial site-level or affiliate experience
• Prior experience with local/country regional requirements
• Strong analytical skills
• Proficiency in use of project management tools and techniques (e.g., Critical Chain, Veeva, MS Project, MS Excel, MS PowerPoint, PowerBI)
• Need to travel periodically to AST/ ISST and potentially other scientific/ regional meetings

WeAreLilly

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.
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.

WeAreLill

Please refer the Job description for details