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Purpose:
The Clinical Development Trial Lead (CDTL), Associate Director/Director independently leads the cross-functional study team in the development and execution of clinical trials and is accountable both regionally and globally to deliver clinical trials timelines with quality, 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 solution 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 implement 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 and identify 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 review 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 studies and/or multiple smaller studies.
Partner with other organizations to coordinate and actively engage 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 and contingency planning. 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 with little/ no need for direct management support. Evaluate and determine issues that require further discussion.
Serve as the CRO (Clinical Research Organization) clinical development point of contact for outsourced and fully outsourced trial execution. Ensure CRO delivery of project timelines.
Clinical Trial Process Leadership and Expertise
Leverage and demonstrate broad understanding of therapeutic, clinical drug development, and process expertise in order to influence study design and program-level decisions considering regional needs.
Recognize inter-relatedness of cross-functional activities and understand the impact of project decisions on the overall clinical trial. Look for opportunities to expand and deepen clinical trial process expertise across functional teams, regions, and external partners and make decisions on process and issues affecting study implementation and execution.
Be knowledgeable on the global and regional operating model; coordinate and facilitate obtaining regional input to provide to the study teams.
Single point of accountability for the Trial Master File for assigned trials, working closely with functional record owners to ensure the file is current and inspection ready at all times.
Ensure inspection readiness of respective clinical trial(s). Ensures documentation of deviations, creation of story boards or issue summary documents (e.g. for high-risk areas/hot topics) and coaches CDTLs in these activities.
Network and use expertise to anticipate trial and regional issues, identify areas of process breakdown, analyze situations and propose innovative approaches that positively impact ability to deliver the clinical trial while reducing and/or mitigating risks. Share process takeaways in order to benefit the Lilly portfolio.
Contribute to the development of others by acting as a coach for peers as well as new CDTLs, cross-functional team members and TPOs on aspects of CT process and regional specificities.
Identify and lead process improvement activities. Acts as a CDTL SME resource to peers and in the development and rollout of new tools, processes or methodologies to proceed as quickly as science allows.
Lead decisively in the midst of ambiguity.
Report, manage and interpret information for the clinical trial(s), including completeness and accuracy across multiple business systems and tools. Be instrumental in driving regional clinical operational processes and methodologies used.
Apply expertise and knowledge of global/regional regulations, Good Clinical Practice (GCP) and Lilly standards of operation in the conduct of clinical trials. Liaise with affiliates and other appropriate resources to understand local regulatory requirements.
Independently detect and resolve quality issues, raising to functional leadership or discuss with other functions (e.g., Medical Quality, Legal, Compliance, etc.) to arrive at the best solution.
Scientific Expertise
Leverage scientific and regulatory knowledge to prepare and/or provide technical consultation for clinical and regulatory documents, prepare for meetings with regulatory agencies and draft responses to questions from regulatory agencies, TPOs and affiliates.
Combine scientific regional, and operational knowledge as well as process expertise to impact clinical trial design, feasibility and implementation.
Leverage clinical development knowledge, problem solving and critical thinking skills to support the scientific needs of the business.
Function as point of contact for Therapeutic Area and/or disease state expertise for others on their clinical team.
Minimum Qualification Requirements:
Bachelor's degree 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
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