Sr Associate / Manager - Clinical Development Trial Lead (Immunology)

Eli Lilly and Company; Cork; On-site; EUR 70,000 - 110,000; Full time

Job summary

Eli Lilly and Company is seeking a Clinical Development Trial Lead (CDTL) Associate to lead cross‑functional trial teams and drive development and execution of clinical trials regionally and globally. You will ensure quality, on‑time delivery within scope and budget, leveraging project management and scientific expertise.

The role requires a science degree with a minimum of 3 years' clinical research or trial experience and willingness to travel periodically to investigator meetings and regional

Qualifications

• Bachelor's or advanced degree in a scientific or health-related field required.
• 3 years of clinical research experience or relevant clinical trial experience.
• Experience leading cross-functional teams is preferred.

Responsibilities

• Lead cross-functional study teams to develop and execute trials.
• Scope, timeline, and risk management across global trials.
• Coordinate ISSTs/ASTs/Investigator Engagement Meetings.
• Ensure Trial Master File is current and inspection-ready.
• Monitor trial budget components and grants/non-grants.
• Apply GCP standards and regional regulatory requirements.

Skills

Trial execution knowledge

Cross-cultural collaboration

Influence without authority

Leadership & networking

Communication & organization

Problem solving

Adaptability

Education

Bachelor's degree in scientific or health-related field

Advanced degree

Job description

Purpose

The Clinical Development Trial Lead (CDTL) Associate leads the cross‑functional study team in the development and execution of clinical trials and is accountable both regionally and globally to deliver trial(s) with quality, on time, and within scope and budget. The CDTL Associate leverages project management, regional operational knowledge, clinical trial process leadership and expertise, and scientific expertise to drive actions and coordinate efforts to achieve or exceed these trial deliverables.

Primary Responsibilities

• Use processes and tools to develop, execute, and deliver local, regional and/or global clinical trials.
• Scope – Understand the scope of work required to complete the clinical trial successfully and monitor status, making changes as needed to meet deliverables.
• Timeline – Develop and track global milestones by gaining alignment and integrating inputs across functions and geographies.
• Risk – Assess, identify and monitor trial‑level risks, creating an integrated risk mitigation and contingency plan.
• Budget – Understand the cross‑functional, trial‑level budget components, create and monitor grants and non‑grants, and track changes with financial tools.
• Partner with other organizations to coordinate and deliver Investigator Study Specific Training (ISSTs)/Affiliate Study Training (ASTs)/Investigator Engagement Meetings.
• Drive and coordinate local, regional and global cross‑functional study teams throughout study implementation, execution and closure, empowering them to meet clinical trial deliverables, including issue management and contingency planning.
• Be accountable for trial/regional enrollment strategy and execution from country allocation through Last Patient Entered Treatment (LPET).
• Partner with the Investigator Engagement organization to achieve regional enrollment goals.
• Manage relationships and serve as the single point of contact and central owner for trial communication with the Clinical Design and Delivery organization, all cross‑functional team members, and Third Party Organizations (TPOs).
• Apply problem‑solving skills to daily issues with the cross‑functional study team, vendors, affiliates/regions, global team members and other business partners.
• Identify and assist in developing continuous improvement activities based on industry, regulatory and new technology trends.
• Manage TPO qualification process, selection and oversight.

Clinical Trial Process Leadership and Expertise

• Demonstrate understanding of drug development process and the inter‑relatedness of cross‑functional activities, and understand the impact of project decisions on the overall trial.
• Be knowledgeable of the global and regional operating model and coordinate the collection of regional input for the study teams.
• Serve as the single point of accountability for the Trial Master File, ensuring it is current and inspection‑ready at all times.
• Network and leverage expertise to anticipate trial and regional issues, identify areas of process breakdown and propose proactive approaches that reduce or mitigate risks.
• Demonstrate ability to lead and influence in the midst of ambiguity.
• Coach peers, cross‑functional team members and TPOs on aspects of clinical trial process and regional specificities.
• Apply expertise and knowledge of global/regional regulations, Good Clinical Practice (GCP) and Lilly standards of operation in the conduct of trials, and liaise with affiliates to understand local regulatory requirements.

Scientific Expertise

• Leverage scientific and regulatory knowledge to prepare and/or provide technical consultation for clinical and regulatory documents, and draft responses to questions from regulatory agencies, TPOs and affiliates.
• Combine scientific clinical trial operational knowledge and process expertise to impact clinical trial design, feasibility implementation and execution.
• Utilize clinical development knowledge, problem‑solving and critical‑thinking skills to support the scientific needs of the business and clinical programs.

Minimum Qualification Requirements

Bachelor's or university degree (scientific or health‑related field preferred) and 3 years of clinical research experience or relevant clinical trial experience in a scientific or health‑related field; or an advanced degree.

Highly Desired Skills

• Applied knowledge of trial execution methodology, processes and tools.
• Demonstrated ability to work cross‑culturally with global colleagues and with TPOs.
• Ability to influence without authority.
• Strong leadership and networking skills exhibited while working in cross‑functional and cross‑cultural teams (internal & external) and on projects.
• Effective and influential communication, self‑management and organizational skills.
• Demonstrated ability to manage complex situations through problem‑solving, critical thinking and navigating ambiguity.
• Flexibility to adjust to altered priorities.

Other Information / Additional Preferences

Need to travel periodically to AST/ ISST/ Investigator Engagement meetings and potentially other scientific or regional symposiums.

Lilly is dedicated to helping individuals with disabilities 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 at 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.