Program Lead, Clinical Delivery - EMP

Eli Lilly and Company • Indianapolis, IN

23h

About The Position

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 Program Lead, Clinical Delivery 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 Program Lead, Clinical Delivery is responsible for planning and delivering exploratory and biopharmaceutics clinical trial and submission milestones on time and on budget throughout the molecule lifecycle. The Program Lead, Clinical Delivery is responsible for all aspects of global clinical trial operations within the plan, as the single operational point of contact for trials from design through execution, including timeline creation and management, outsourcing plan, vendor management (including oversight of the operational deliverables), and budget management. The Program Lead will seek knowledge from internal and external sources and use this information to shape development plans and continuous improvement opportunities. 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.

Requirements

• Bachelor’s degree in a science related field from an accredited college or university.
• 3-years’ experience in the pharmaceutical industry with direct experience of handling clinical studies, ideally in exploratory and bio-pharmaceutics clinical development
• Experience with the regulations and guidelines that apply to the conduct of clinical trials.
• Experience overseeing TPOs to enable delivery of trial level results.
• Experience with project management tools and processes.

Nice To Haves

• Advanced scientific degree
• Exploratory and bio-pharmaceutics clinical development experience preferred
• Immunology and/or Oncology clinical development experience preferred
• Vendor management and contracting experience.
• Demonstrated ability to work effectively cross-culturally and in a virtual work environment.
• Demonstrated ability to influence both internal and external environments appropriately 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 digital literacy; skilled at using Word, Excel, PowerPoint, and Microsoft Project
• Ability to travel (up to 10% expected)
• Proven experience of coaching and mentoring others.
• Demonstrated high-level, end-user digital literacy (e.g., word processing, tables and graphics, spreadsheets, presentations, and templates).

Responsibilities

• Leads the development of the clinical asset strategy for phase 1 leveraging quality decision making principles.
• Understands 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 best practices.
• 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.
• 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 team and to functions, affiliates, and leadership.
• 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 selection process and management of vendors, ensuring day to day oversight for operational deliverables of 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
• 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 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, 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.
• Recruits, develops, and retains a diverse and highly capable workforce.
• Ensures robust individual training plans and timely completion of required training for direct reports.
• Supports and enables talent identification and career development that reflects an end-to-end attitude and demonstrates judgement-based decision making.
• Contributes to succession planning, talent assessment and performance/promotion processes.
• Ensure high talent staff are appropriately rewarded and developed.
• Models behaviors 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.
• Develops 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.
• Coaches and mentors department personnel, and as needed, cross-functional members, in order to affect development and growth of all team members.

Benefits

• employees also will be eligible for a company bonus (depending, in part, on company and individual performance)
• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level