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

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.

Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our 'Live Your BEST Life'

wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.

Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, embRACE, LGBTQ+ & Ally and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.

Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!

This is a 12-month fixed-term contract.

Overview

The purpose of the Associate Director - Clinical Delivery & Capabilities, EMP leads the group of Clinical Delivery team and Capabilities team and provides direction and leadership for the creation and continual improvements of their work. The Associate Director will provide strategic direction and leadership for the team in Cork for the Delivery and the Capabilities team within EMP.

The Associate Director will lead the creation and execution of the exploratory and biopharmaceutics clinical development and delivery plan at a molecule level, with technical leadership and delivery oversight of clinical research trials within the development plan. The Associate Director is responsible for planning and delivering exploratory and biopharmaceutical clinical molecules and submitting clinical milestones on time and within budget throughout the molecule lifecycle. The Associate Director will be responsible for all aspects of global clinical trial operations within the plan as the single operational point of contact from trial design through execution and closeout, including timeline creation and management, outsourcing plan, vendor management (including direct oversight of the operational deliverables), patient recruitment and retention and budget management. Depending on the operational/resource model chosen and influenced by the needs of the clinical development program, the Associate Director may be assigned additional trial-level management support from internal or external resources. The Associate Director will seek knowledge from internal and external sources and use this information to shape development plans and continuous improvement opportunities.

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.
• Demonstrated high-level, end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentations and templates).
• Strong knowledge of regulations and guidelines that apply to the conduct of clinical trials.
• Ability to influence and oversee TPOs to enable Delivery of trial-level deliverables.
• Demonstrated knowledge and experience with project management tools and processes.
• Demonstrated ability to work effectively cross-culturally and in a virtual work environment.
• Demonstrated ability to appropriately influence internal and external environments and forge strong working relationships.
• Demonstrated problem-solving skills; able to anticipate and recognize systemic problems, diagnose root causes and take corrective actions to prevent recurrence within the team.
• Strong self-management, organizational and interpersonal skills and the ability to be flexible in varying environments and with multiple customer groups.
• Strong leadership and networking skills.
• Excellent oral and written communication skills; able to communicate clearly and with team members and leadership
• Strong computer skills; skilled at using Word, Excel, PowerPoint, and Microsoft Project
• Ability to travel (up to 10% expected)

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 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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