Senior Director - Clinical Operations

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.

Position Summary: 

This individual will lead clinical studies and/or programs within early phase oncology portfolio with responsibility for strategic planning and execution related to development and daily operations. This individual must possess an expert understanding of ICH/GCP requirements, principles, concepts, industry practices, and standards, as they relate to global clinical trials for an established oncology company.

The Senior Director, Clinical Operations is responsible for the successful execution of clinical trials and/or programs according to regulatory guidelines as well as facilitating effective internal and external relationships for achievement of project goals and objectives, on time and on budget.  This individual serves as an operational leader, as well as mentor to other Clinical Operations team members, organizing Clinical Operations program / study responsibilities, and serves as a point of issue escalation.

*Roles and Responsibilities of the Position:

• Provide technical expertise, strategic input, and operational leadership, coaching, and mentoring, across a drug program/clinical trial, through collaboration with internal and external stakeholders, considering consistency within the program and overall optimization of clinical plans.

• Lead Clinical Operations team members on the program/clinical trial and as needed drive to solutions and facilitate decision making across a multi-functional study team.

• Anticipate and resolve complex and key technical, operational, or business problems within multi-functional study team and/or drug program; serve as a clinical trial escalation point and evaluate and determine issues that require further escalation.

• Proactively identify potential risks across the clinical trial and/or drug program and the Clinical Operations group; lead the development/implementation of actions to avoid or mitigate; identify points for escalation.

• Serve as escalation point for Clinical Operations team members.

• As appropriate per vendor/scope of work, provide direction and support in the selection process for key vendors, especially CRO selection; serve as escalation point for vendor management/oversight. 

• Maintain a compliance culture and a state of inspection readiness within a clinical trial and within the clinical operations group; partner with QA and other stakeholders to provide support for inspection/audit readiness across the program.

• Drive timeline planning for a clinical trial in accordance with program priorities.

• In conjunction with finance and project management, drive development and tracking of the clinical budget for a clinical trial.

• Communicate and align cross-functionally to help execute the Company’s operational and business strategy. This may include contributing as the Clinical Operations functional lead in development strategy meetings.

• May assist with development and continual improvement of Clinical Operations departmental infrastructure including development of SOPs and best practices.

• Maintain a transparent, flexible, can-do approach to address issues innovatively, collaboratively, and proactively & to promote teamwork and a pleasant work environment.

• Maintain flexibility and ability to take on additional or alternative roles/responsibilities as required for the Company if the job requirements evolve.

• Will coordinate activities of other study team members to ensure efficient delivery of key milestones (may be applicable to Contractors/Consultants as needed).

• May oversee the activities of other team members (may be applicable to Contractors/Consultants as needed).

• May have line management responsibilities, participating in resource planning, recruitment and talent development activities as needed (not applicable to Contractors/ Consultants)

Basic Requirements:

• BA/BS degree in a relevant discipline required, advanced degree preferred.

• 8+ years of experience in clinical drug development with 3+ years of direct sponsor and/or CRO experience req