Sr. Director, ExploR&D Clinical Operations
Offer summary
Qualifications:
Bachelor's degree in a science or related field; advanced degrees preferred., Minimum of 8 years experience managing early phase clinical studies., Experience in sourcing and contracting within the pharmaceutical industry., Knowledge of clinical trial implementation in the Asia-Pacific region..Key responsibilities:
- Ensure GCP systems are properly implemented and maintained.
- Develop and oversee clinical strategies and operational plans for biotech collaborations.
- Manage and mentor clinical operations staff and coordinate with external partners.
- Assess clinical trial progress and develop mitigation strategies as needed.
Job description
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 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.
- 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.
- Leverage new Lilly and ExploR&D clinical capabilities along with all IT capabilities and effectively utilize for delivering the portfolio.
- Collaborate with Clinical Operation Associate Director/Director to stimulate, collate, and facilitate implementation of new ideas for operational processes/process improvements to align with future ExploR&D operating model.
- 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.
Clinical Operations: Role-based Training Plan
- Recruit, manage, develop, train, oversee and retain personnel to assist with the development and implementation of the ExploR&D initiatives.
- Provide management and mentoring of ExploR&D direct reports and team members, if applicable.
Basic Requirements
- Bachelor's degree in a science or 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
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$151,500 - $222,200Full-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).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Required profile
Experience
Other Skills
- Quality Assurance
- Mentorship
- Coaching
- Team Management
- Collaboration
- Communication
- Problem Solving
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