ExploR&D Sr. 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.

Purpose Of The Job:

At JP Morgan 2024, Dave Ricks announced Lilly Catalyze360, our external innovation organization dedicated to biotech collaboration which is comprised of three pillars: Lilly Ventures, providing capital direct to biotechs and via a fund-of-funds investment strategy; Lilly Gateway Labs, a best-in-class network of biotech incubators; and ExploR&D.

Within ExploR&D our mission is to unleash Lilly's world-leading capabilities and know-how to accelerate the science of our biotech collaborators to value inflection, and to patients. Through a unique model that mixes dedicated headcount and flexible use of functional and therapeutic area expertise, we will provide the knowledge and services to enable our collaborator's programs. Through our work we ensure Lilly is networked with the brightest scientific minds around the world to continue to make Lilly smarter, create value for Lilly and the entire scientific ecosystem, and position Lilly as a partner of choice for biotechs to fuel our industry-leading pipeline with best external innovation. With the pace of technological disruption accelerating, ExploR&D also affords Lilly an agile way to pilot and deploy new technologies and vendor solutions that can increase the speed and efficiency in the way drugs are discovered and developed, both for our biotech collaborators, and by providing de-risked opportunities to evolve how Lilly and LRL operates.

The purpose of the job is to ensure ExploR&D has adequate Good Clinical Practices (GCP) systems in place that are properly executed. Responsibilities include assurance of adequate, phase appropriate, fit for purpose systems for ExploR&D to conduct GCP-regulated work, in accordance with the ExploR&D Quality System as well as applicable regulations and international guidelines. Responsibilities also include performing or managing GCP audits and assessments of Clinical Third Party Organizations as needed.

This role will contribute to ExploR&D maintaining a strong Quality Culture, that enables robust business partnerships with external companies developing molecules in early phase clinical trials.

The Sr. Director ExploR&D Clinical Operations is entrusted with the development of specific clinical strategies in collaboration with medical teams for biotechnological enterprises. The Senior Director will also undertake research to provide trial feasibility assessments, country allocation, and competitive intelligence as required. They will implement the ExploR&D clinical portfolio with efficacy and innovation.

Core Job Tasks:

Clinical Operations: Role-based Training Plan (Clinical Operations 1)

• Ensure alignment between overall clinical operational strategy and tactical implementation of the ExploR&D portfolio.
• Develop and implement integrated clinical operations development plan for assigned asset(s).
• Effectively link and leverage ExploR&D clinical capabilities, innovation and IT strategy, and clinical expertise across the portfolio to enable expedited and innovative study data delivery for all assets.
• Influence ExploR&D and external leadership with respect to key decisions regarding clinical operations, drive efficiency and innovation opportunities (e.g., design optionality, geographic region(s), psm rates, site selection strategy, CRO selection, etc.) across the portfolio to improve the efficiency of our clinical plans, confidence, and on-time delivery, of our clinical portfolio.
• Contribute to clinical operations due diligence efforts for assessing "ExploR&D fit" for Joint Venture Partner, or externally licensed assets.
• Experience with implementation of clinical trials in China

• Contribute to the development of others by actively coaching/mentoring co-workers both internal and external to ExploR&D.
• Closely collaborate with Clinical Operations team to assess the progress of clinical plans and studies and aid in development of mitigation action plans, as needed, with staff to resolve issues and barriers to meeting committed milestone dates.
• Contribute to ExploR&D Clinical and associated SOPs and corresponding checklists to ensure appropriate linkages to Lilly Standards.

Basic Requirements:

• B.S. degree in a science related field from an accredited college or university. Advanced degrees and/or additional degrees in finance, accounting, legal or MBA preferred.
• 8+ years work experience directly managing clinical studies with emphasis on early phase and outsourced trials.
• 8+ years work experience directly dealing with sourcing and contracting work in the pharmaceutical industry.

Additional Skills:

• Demonstrated working knowledge of key contractual provisions (e.g., intellectual property, indemnification, confidentiality, etc.).
• Experience implementing clinical trials in the Asia-PAC region.

Additional Information:

• International and Local travel will be required.
• Position is located in Indianapolis, Indiana (relocation provided) or remote