Associate Director - Chorus - Clinical Operations and Project Management
Eli Lilly
- Cork
- Permanent
- Full-time
Chorus, a Division of Lilly Research Laboratories, is a virtual development organization that manages a broad portfolio of New Molecular Entities from Candidate Selection through clinical Proof of Concept. Chorus collaborates with a network of external experts to devise clinical strategy, design protocols, and conduct experiments. Chorus seeks to conduct studies that have highest impact on probability of success in an efficient manner, while managing uncertainty and optimizing investment in secondary goals. The Chorus model seeks to advance Lilly as well as external molecules through the drug development cycle or enable clear termination decisions based on efficient proof-of-concept studies. The role has responsibility for the technical management and operational oversight of clinical research trials for assigned assets in the Chorus portfolio. The Chorus Associate Director will be responsible for all aspects of global clinical trials operations, from conception through execution to close out, including timeline creation and management, outsourcing strategy, vendor management, patient recruitment and budget management. The Chorus Associate Director will achieve this through clinical development expertise and effective cross-functional partnership with the Chorus Asset Team. The Chorus Associate Director will also provide leadership and clinical operations technical/process expertise. They will also model and reinforce Lilly and Chorus leadership behaviors.JOB RESPONSIBILITIES:1. Clinical Planning and Execution
- Accountable for oversight of clinical operations and delivery of clinical project milestones on time and on budget
- Create and manage implementation timeline and clinical trial activities via the Chorus custom database and Project Management tools
- Accurately forecast and track direct expenses for clinical budgets
- Document key team information and clinical decisions in Chorus custom tracking and communication database
- Manage clinical operational risks and their impact to the timelines and budgets of clinical studies, including critical path activities
- Select and manage external network of vendors to ensure on time and on budget clinical project deliverables
- Establish and manage Clinical vendor expectations, performance, and delivery
- Serve as the central point of contact for the global clinical team, to resolve clinical implementation issues (internal and external), lead risk assessments and contingency planning, and effective communication across and upward
- Partner with regulatory and medical to ensure safety management and monitoring processes are implemented
- Provide input into molecule development, clinical regulatory and safety strategy
- Manage global cross-functional communication and escalations to ensure alignment on delivery and execution
- Utilize clinical operations process knowledge to drive decision making.
- Participate in review of clinical database specifications and utilization
- Manage the writing and approval of informed consent documents
- Initiate clinical change control process for studies, as appropriate
- Maintain a state of inspection readiness for clinical development inclusive of TMF.
- Model essentialism and judgement-based decision making to navigate compliance and quality requirements.
- Ensure technical competencies evolve as needs of the business strategy evolve
- Consistent demonstration of leadership behaviors
- Proactive communication with asset team members
- Lead a team of people with or without formal authority to deliver on an objective
- Exercise sound judgment and take and defend tough positions
- Ability to use sound judgment when interacting with various sponsors (internal and external) while maintaining the Chorus brand image
- Support the technical development of diverse and highly capable workforce
- Embrace an organizational culture that fosters diversity, equity, and inclusion
- Embody the Lilly Values of Respect for People, Excellence and Integrity
- Bachelor’s degree, preferably in a scientific or health-related field
- Project Management certification (e.g., PMP)
- Early phase clinical trial operations experience
- Minimum of 5 years’ experience in the pharmaceutical industry and/or clinical development
- Must understand clinical development processes and the interdependencies of various tasks that require coordination among asset team, functional/regional team members and third parties
- Demonstrated core project management skills through management of complex/cross-functional projects, and/or clinical trials with a strong knowledge of regulations and guidelines
- Proven ability and experience with coaching others
- Ability to embrace the diversity of thought to model innovative behaviors (e.g., reaching across boundaries, inspire and empower others and lead decisively in the midst of ambiguity)
- Strong communication skills; able to communicate clearly and succinctly with team members and leadership
- Ensures effective cross-functional communication with internal and external experts
- Prior experience in working with a non-Lilly business partner (e.g., CRO, Alliance, Joint Venture)
- Strong self-management and organizational skills; able to manage workload, set personal and team priorities and adjust as needed
- Able to influence others without direct authority
- Strong problem-solving skills: able to anticipate and recognize systemic problems, diagnose root causes, and take corrective actions to prevent reoccurrence