Associate Director, Clinical Development Trial Lead

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work-but it's work worth doing. If you're driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Purpose:

The Clinical Development Trial Lead (CDTL), Associate Director/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. 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.

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 timely 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 leverage 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 learnings 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.
• Maximize shared learning opportunities within their clinical team capitalizing on best practices.
• 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, escalating to functional leadership or consulting 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:

• Bachelors or University degree (scientific or health-related field preferred)
• 5 years clinical research experience or relevant experience in a scientific or health-related field; or an advanced degree.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or Visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1

Highly Desired Skills:

• Large-scale global trial execution. Experience leading a 10,000-patient, 26-country global CVOT with reported 99% retention, demonstrating expertise in large, complex multinational study delivery and performance management.
• Organizational leadership and capability building. Strong focus on coaching and developing CRAs and clinical teams, leading enterprise learning forums, mentoring programs, and hands-on training initiatives to improve operational excellence across the organization.
• Inspection readiness, quality governance, and CAPA leadership. Significant involvement in audit and inspection preparedness, enterprise process audits, CAPA development and implementation, eTMF oversight, and cross-functional quality governance, including support of FDA and EMEA inspections with no major findings reported.
• Experience partnering with Academic Research Organizations (independent oversight) as well as adjudication experience.
• 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

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 is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is

$115,500 - $187,000

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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