Associate Director – Clinical Trials Project Manager - Exploratory Medicine & Pharmacology (EMP)

In addition, the Associate Director will contribute and drive continual improvements of the Clinical Delivery Capabilities function to support fit-for-purpose delivery models, quality and speed of exploratory and biopharmaceutical clinical development. Their team provides operational support to project teams on a)systems and processes, b) training, c) sourcing and contracts, d) quality and inspection readiness and e) metrics, analytics and insights from EMP and/or other clinical trials conducted by Lilly or competitors collection, assessment and reporting.

Scientific and Therapeutic Area Expertise

Provides consultation to the project team for clinical and regulatory documents such as study protocols, Investigator Brochures (IBs), risk profiles, annual reports, briefing documents, New Drug Applications (NDAs), safety updates, clinical study reports (CSRs), abstracts, publications and manuscripts.

Stays up-to-date with current body of knowledge of relevant disease states/targets, competitors, and industry trends and best practices.

Maintains knowledge of operational requirements to effectively plan in detail exploratory and biopharmaceutics clinical development studies and submissions e.g. FHD requirements, detail of operations to deliver critical path studies and submissions.

Clinical Project Management

Leads and has expertise in the implementation and integration of clinical project management processes and tools.

Works with Third Party Organizations (TPOs) to execute the defined clinical strategy, overseeing key trial deliverables.

Develops and maintains up-to-date clinical plan timelines and process maps (if appropriate) ensuring communication of progress to the broader molecule team.

Partners with the financial organization, cross-functional partners, and geographies, to develop and manage the overall clinical budget for the molecule-level book of work including initiation and management of the change process.

Proactively identifies and communicates clinical risk assessment and mitigation/contingency plans within the team and to functions, affiliates and leadership.

Clinical Delivery

Accountable and responsible for oversight of clinical trial operations and Delivery of clinical project milestones on time, on budget

Create and manage implementation timeline and clinical trial activities

Involved in the selection process and management of vendors, providing day-to-day oversight for operational deliverables with an external network of vendors to ensure on-time and on-budget clinical project deliverables

Serves 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

Study Set-up, Execution and Delivery Support

Provide leadership in the area of clinical capabilities for exploratory and biopharmaceutical clinical studies. Their team will support study development by owning updates to corporate systems and processes e.g. CT Registry, Vault Clinic, trial and compound level documentation process and training e.g. eTMF. The Associate Director and team will work closely with the TA clinical delivery Sr Directors and their study set up and operations teams in supporting initiation and execution of studies through updating and providing adjustments and improvements to study set up, execution up to DBL/CSR and respective systems and processes support.

The Associate Director will network with other key support areas to efficiently and effectively support EMP delivery across TAs, namely with individuals with responsibility for clinical grants, procurement, quality, CLS, Data management and clinical and trial capabilities groups within CDDA.

Provide leadership to the team involved in TPO relationship management and expertise in business interactions with internal and TPO partners to execute the portfolio as efficiently and effectively as possible. Involved in the issue escalation process when appropriate. Provide a sourcing plan adjusted to the portfolio needs and the support for RFI/RFPs and contracting elements for a study.

Communication and Team Management

Influences and works with quality mindset across the clinical team by documenting key decisions, actions and key modifications in clinical scope, resources and timeline; ensuring accurate collection and communication of clinical metrics; ensuring archival of all relevant clinical information at the termination of a project and as appropriate throughout the project.

Manages key partnerships and interactions/integration with the clinical team, including leadership in governance forums (if applicable).

Effectively and reliably communicates and influences at all levels across the organization clear and concise information to enable decision-making by team and governance/Stakeholders.

People Management

Recruit, develop, and retain a diverse and highly capable workforce

Ensure robust individual training plans and timely completion of required training for direct reports.

Support and enable talent identification and career development that reflects an end-to-end mindset and demonstrates judgment-based decision-making.

Contribute to succession planning, talent assessment and performance/promotion processes. Ensure high-talent staff are appropriately rewarded and developed.

Model behaviours and establish an environment where performance and results are valued and where individuals are learning and growing developmentally.

Seek opportunities to reward and recognize individuals and teams.

Manage Team workload based on portfolio prioritization, regional requirements, and individual level of expertise, and address implications to overall resource management and strategies.

Supports and encourages a culture of innovation and the learning that comes from new/novel approaches to clinical development and models inclusivity to ensure diverse voices and ideas are heard and considered

Coach and mentor department personnel, and as needed, cross-functional members in order to affect the development and growth of all team members.

Leadership

Collaborates effectively with colleagues at all levels; able to work with, and deliver, through others.

Skilled at working through ambiguity and effective problem-solving/solution-oriented skills to help develop and evaluate molecule-level strategies from lead to legacy.

Successful in persuasion, influence, and negotiation skills in a matrix environment.

Fosters spirit of learning agility, strategic thinking and the ability to think differently to incorporate new learning

Contributes to the development of others by being an active source of constructive coaching and feedback to co-workers.

Minimum Qualifications

• Bachelor’s degree in a science-related field from an accredited college or university.
• Advanced or Post-graduate degree, e.g., Pharm D, MS, MBA or PhD.
• 3-5 years experience in the pharmaceutical industry with direct experience in managing clinical studies, ideally in exploratory and biopharmaceutical clinical development (5+ years preferred).
• 5+ years’ experience in the pharmaceutical industry with drug development experience within clinical, quality, regulatory or safety; experience within various functional areas is an advantage.

Additional Skills/Preferences

• Exploratory and biopharmaceutics clinical development experience preferred
• Vendor management and contracting experience.
• Proven experience in coaching and mentoring others.