Associate Director - Trial Capabilities, Budgets & Contracts
Apply locations Ireland, Cork time type Full time posted on Posted 7 Days Ago job requisition id R-76451
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.
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. The Associate 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 works closely with functional partners and the global study teams ensuring accurate planning and prioritization to meet portfolio needs. The Associate Director anticipates and mitigates risks and ensures timely issue resolution. The Trial Capabilities Associate 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
1. Clinical Trial Leadership
o Lead and coordinate the execution of clinical trial budgets and contracts activities across country/region for high priority and complex trials.
o Leverage deep expertise in regional trial execution to support Trial Capabilities representation in global, cross-functional clinical trial forums.
o Anticipate and mitigate risks and resolve complex and critical risks/issues.
o Influence execution based on knowledge of regulations and applying learnings from regulatory feedback.
o Support implementation and drive compliance to value-added projects.
o Lead and support global functional projects related to integration of processes and automation.
o Provide input into the design and implementation of value-added solutions.
o Contribute scientific and disease expertise and utilize strategic knowledge of Lilly’s portfolio.
o Recognized as an expert in local/global regulations and assess the impact on processes.
o Lead and consult on internal audits and external inspections.
2. Business Management and External Influence
o Drive and/or support discussions with regulatory bodies.
o Engage with regulatory bodies to influence clinical trial execution.
o Lead Trial Capabilities team to effectively manage budgets and contracts activities.
o Proactively identify process improvement opportunities.
o Identify and develop robust mechanisms to retain a skilled workforce.
o Effectively manage an agile organization.
o Act as a subject matter expert coaching and mentoring individuals.
o Develop an organizational culture that fosters inclusion and innovation.
o Understand and comply with procurements, legal, data privacy and financial requirements.
3. Organizational Leadership
o Identify and ensure shared learning across the clinical organization.
o Build capabilities in the function through the development and improvement of processes.
o Enable a culture of continuous improvement.
o Manage staff compliance to local regulations and guidance.
4. People Management and Development
o Recruit, develop, and retain an operationally capable workforce.
o Effectively manage an agile organization.
o Develop an organizational culture that fosters inclusion and innovation.
Minimum Qualification Requirements:
* Bachelor’s degree preferably in a scientific or health-related field.
* Experience 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.
* Understanding of the overall clinical development paradigm.
* Proficiency in country/regional regulatory and legal guidelines/requirements.
* 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.
* Strong teamwork and interpersonal skills.
This position is based in Cork, Ireland and would require you to relocate if living outside of the Republic of Ireland.
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 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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