Associate Director/Director, Clinical Delivery Capabilities - EMP

Lilly • Indianapolis, IN

6d • $115,500 - $169,400 • Onsite

About The Position

The Associate Director/Director, Clinical Delivery Capabilities plays a critical role in shaping how Lilly selects, manages, and partners with external vendors to ensure the quality and on-time delivery of its early-phase medicine portfolio. This role will work cross functionally to set the operational standards, systems, and processes that hold clinical research partners accountable and drive consistent, high-quality outcomes across every study in the pipeline. The purpose of the Associate Director/Director, Clinical Delivery Capabilities (CDC) role is to provide operational leadership to support exploratory and biopharmaceutics clinical development. The role works across the organization including with functional and organizational partner groups to deliver knowledge, expertise, standard templates, and technology to identify various clinical development scenarios and provide functional expertise to ensure successes of portfolio delivery. This role continually provides expertise in process and methodologies of Exploratory Medicine & Pharmacology (EMP) whilst looking for advancements and improvements. Key areas of responsibility of the role include: a) leading activities supporting study development and execution, b) cross-functional systems and processes, and c) systems, metrics and reporting. In addition to knowledge of ICH and quality guidelines needed for successful delivery of the portfolio and clinical trials, the Associate Director/Director possesses the discernment, process knowledge, and influence required to lead in process and quality improvement efforts. The Associate Director/Director will seek knowledge from internal and external sources and use this information to drive strategic discussions with clinical and functional counterparts make recommendations to gain efficiencies and speed to shape development plans and improvement opportunities.

Requirements

• Bachelor’s degree in a science related field from an accredited college or university; or equivalent qualifications/experience
• 3-years’ experience in the pharmaceutical industry with direct experience of managing clinical studies
• Project management and time management skills.
• Experience working cross-culturally and in a virtual work environment.
• Ability to travel (up to 10% expected – varies dependent on responsibilities)

Nice To Haves

• Advanced scientific degree
• Ideally in exploratory and bio-pharmaceutics clinical development (5+ year preferred)
• Solid understanding of regulations and guidelines that apply to the conduct of clinical trials.
• Direct supervisory experience
• Demonstrated ability to influence both internal and external environments appropriately and forge strong working relationships.
• Strong organizational and interpersonal skills and the ability to be flexible in varying environments and with multiple customer groups.
• Strong verbal reasoning, attention to detail, critical thinking, problem solving, and analytical abilities.
• Proven experience of coaching and mentoring others.
• Deep expertise in one or more clinical research functions (clinical operations, sourcing, data sciences)
• Vendor management and contracting experience.
• Exploratory and biopharmaceutics clinical development, quality and Six Sigma experience preferred.
• Demonstrated high-level, end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentations and templates).
• Demonstrated experience in Organizational Change Management (OCM), with a strong ability to lead teams through transitions involving new systems, tools, or process changes.

Responsibilities

• Establish networks with other key support areas to efficiently and effectively support exploratory and biopharmaceutics clinical studies.
• Support study development by owning updates to corporate systems and processes e.g. CT Registry, Vault Clinical; trial and compound level documentation management e.g. eTMF and the contracting elements for a study.
• Provide leadership in business interactions with TPO partners; helping to implement the exploratory and biopharmaceutics clinical development portfolio.
• Lead and partner in the issue customer concern and relationship management processes, vendor and clinical research unit assessments as appropriate.
• Maintain awareness of regulatory issues and trends relevant to assigned portfolio.
• Provide leadership in business processes supporting early phase development.
• Established expertise on key business systems that support exploratory and biopharmaceutics clinical development.
• Review of established procedures across multiple subject areas, dependent on the change agendas to be evaluated and prioritized.
• Contribute to the overall strategic direction of cross-functional systems and process.
• Draw on deep exploratory and biopharmaceutics clinical development knowledge and process expertise to review processes and when vital, sponsor improvement initiatives to increase business efficiency and value.
• Ensure cross-functional process alignment internally and externally where appropriate.
• Act as a key resource to internal governance committees regarding processes applied in the exploratory and biopharmaceutics clinical development.
• Ensure optimal network with the Quality, Clinical Information and Process Automation, and L&D organizations is established in order to guarantee processes deliver on Quality and Regulatory compliance requirements.
• Lead organizational change initiatives to ensure successful adoption of new clinical delivery capabilities, systems, and processes.
• Lead and collaborate with cross-functional teams to assess change impacts, develop communication strategies, and coordinate delivery of training.
• Act as a change advocate, helping collaborators navigate transitions and embedding change into team culture and workflows.
• Drive definition of metrics or measures to quantify exploratory and biopharmaceutics clinical development portfolio results and assess process effectiveness.
• Develop a metrics / measures and evaluation strategy for the organization.
• Establish and operationalize the processes to support this strategy e.g. scorecard generation.
• Drive identification and development of emerging technologies to support the advancement of medicines to the clinic. e.g. Artificial Intelligence tools.
• Review the implementation progress of implemented systems and/or recommend corrective actions, if needed.
• Attract, retain and develop a diverse workforce.
• Model 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.
• Provide supportive environment for staff to explore innovative solutions to business problems and implement strategic and tactical decisions.
• Contribute to succession planning, talent assessment and performance/promotion processes.
• Ensure high talent staff are appropriately rewarded and developed.
• Coach and mentor department personnel, and as needed, cross-functional members, in order to affect development and growth of all team members.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• 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
• 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: Senior