Associate Director/Director, Clinical Delivery Capabilities - EMP

Eli Lilly and Company•Us, IN

25d

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. The purpose of the Associate Director/Director Clinical Delivery Capabilities role within Exploratory Medicine and Pharmacology 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 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 business acumen, 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 continuous improvement opportunities. Study Development and Execution Support: Establish networks with other key support areas to efficiently and effectively support exploratory and biopharmaceutics clinical studies. The team will 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 execute the exploratory and biopharmaceutics clinical development portfolio. Lead and partner in the issue escalation and relationship management processes, vendor and clinical research unit assessments as appropriate. Maintain awareness of regulatory issues and trends relevant to assigned portfolio. Cross-Functional Systems and Processes: 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 necessary, 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 utilized 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. Systems, Metrics and Reporting: Drive definition of metrics or measures to quantify exploratory and biopharmaceutics clinical development portfolio deliverables 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 Monitor implementation progress of implemented systems and/or recommend corrective actions, if needed 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 Monitor implementation progress of implemented systems and/or recommend corrective actions, if needed. People Management and Employee Development: 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.

Requirements

Bachelor’s degree in a science related field from an accredited college or university; with (3-years’ experience in the pharmaceutical industry with direct experience of managing clinical studies)
Experience with regulations and guidelines that apply to the conduct of clinical trials.
Project management, leadership and time management skills.
Experience working cross-culturally and in a virtual work environment.

Nice To Haves

Advanced scientific degree (PharmD etc.)
5-years’ experience in the pharmaceutical industry with direct experience of managing clinical studies, ideally in exploratory and biopharmaceutics clinical development.
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.
Ability to travel (up to 10% expected – varies dependent on responsibilities)

Responsibilities

leading activities supporting study development and execution
cross-functional systems and processes
systems, metrics and reporting
Establish networks with other key support areas to efficiently and effectively support exploratory and biopharmaceutics clinical studies.
Provide leadership in business interactions with TPO partners; helping to execute the exploratory and biopharmaceutics clinical development portfolio.
Lead and partner in the issue escalation 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.
Contribute to the overall strategic direction of cross-functional systems and process.
Act as a key resource to internal governance committees regarding processes utilized in the exploratory and biopharmaceutics clinical development.
Drive definition of metrics or measures to quantify exploratory and biopharmaceutics clinical development portfolio deliverables 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
Monitor 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

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).

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