Associate Director, Clinical Delivery Program Lead

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Purpose:

The purpose of the Clinical Delivery Program Lead is to lead the creation and execution of the exploratory and biopharmaceutics clinical development plans at a molecule level, with technical leadership and operational oversight of clinical research trials within the development plan. The Clinical Delivery Program Lead is responsible for planning and delivering exploratory and biopharmaceutics clinical molecules and submissions milestones on time and on budget throughout the molecule lifecycle. Additionally, this role is 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 close out, including timeline creation and management, outsourcing plan, vendor management (including direct oversight of the operational deliverables), patient recruitment and retention and budget management.

Dependent on the operational/resource model chosen and motivated by the needs of the clinical development program the Consultant may be assigned additional trial level management support from internal or external resources. The Consultant will seek knowledge from internal and external sources and use this information to craft development plans and improvement opportunities.

Scientific and Therapeutic Area Expertise

• Lead the development of the clinical asset strategy for phase 1 using quality decision making principles.
• Understand assigned therapeutic area including trial designs, risks and execution challenges and best practices.
• 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 standard methodologies.
• Maintains knowledge of operational requirements to effectively plan exploratory and biopharmaceutics clinical development studies and submissions e.g., FHD (First Human Dose) 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 implement the defined clinical strategy, overseeing key trial results.
• 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 lead 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 team and to functions, affiliates, and leadership.

Clinical Operations:

• Accountable and responsible for oversight of clinical trial operations and delivery of clinical project milestones on time, on budget
• Create and lead implementation timeline and clinical trial activities
• Involved in selection process and management of vendors, providing day to day oversight for operational results with external network of vendors to ensure on time and on budget clinical project deliverables
• Serves as the 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

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.
• Handles 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

Leadership:

• Collaborates effectively with colleagues at all levels; ability 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.
• Champions spirit of learning agility, critical 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 Qualification Requirements:

• Bachelor’s degree in a science related field from an accredited college or university.
• 5-years of experience in the pharmaceutical industry managing clinical studies
• 3 years manging Phase 1 studies including exploratory and biopharmaceutics clinical development.

Other Information/Additional Preferences:

• Advanced scientific degree
• Exploratory and biopharmaceutics clinical development experience preferred
• Vendor management and contracting experience.
• Experience coaching and mentoring others.
• Demonstrated high-level, end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentations, and templates).
• Solid understanding 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.
• Knowledge and experience with project management tools and processes.
• Demonstrated ability to work optimally cross-culturally and in a virtual work environment and to influence both internal and external environments appropriately forging strong working relationships.
• Demonstrated problem-solving skills. Ability 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
• Expertise with various programs including Word, Excel, PowerPoint, and Microsoft Project
• Ability to travel up to 10%

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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

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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