Associate Director, Clinical Client Relationship Manager

Key Skills

Data science techniques, Leadership Skill, Lean Six Sigma, Operations, Project management

Job Description

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 possesses the business acumen, process knowledge, and influence required to lead in process and quality improvement efforts.

The Associate 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.

Primary Responsibilities:

 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.

 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.

Minimum Qualification 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, ideally in exploratory and biopharmaceutics clinical development (5+ year preferred)). Strong knowledge of regulations and guidelines that apply to the conduct of clinical trials.

• Vendor management and contracting experience.

• Demonstrated project management and time management skills.

• 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.

• 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.

Other Information/Additional Preferences:

• Advanced scientific degree

• Direct supervisory experience

• Deep expertise in one or more clinical research functions (clinical operations, sourcing, data sciences)

• 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).

• Ability to travel (up to 10% expected – varies dependent on responsibilities)

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.