Sr. Director – Externally Sponsored Research and Access Programs

Industry:

Company: Eli Lilly and Company

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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$151,500 – $222,200

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Main Purpose and Objectives of Position:
In addition to Lilly-sponsored research, Lilly provides support for Externally Sponsored Research (ESR) and Access programs with provision of study drug and/or financial support.

• Investigator Initiated Research (IIR) is initiated, designed, and sponsored by external researchers. Lilly considers such requests for support of Investigator Initiated Research (IIR) projects based on scientific merit and strategic fit with Lilly’s areas of research interest.
• Expanded access is the provision of an investigational medicinal product (IMP) for treatment of patients with a serious or life-threatening condition who are unable or do not qualify to participate in a clinical trial and for whom no satisfactory alternative therapy is available. Expanded access is not conducted for the purpose of answering research questions. Expanded access is known by other terms in different countries, such as compassionate use, emergency use, authorization for temporary use, individual patient investigational new drug (IND), named patient use (NPU), and named patient access program.
• Externally Sponsored Collaborative Research (ESCR) may be initiated by the Sponsor or may be a collaborative effort to explore a research objective.

The Clinical Central Services function partners with the Business Units and across functional support (Quality, medical, medical affairs, legal, safety, CT supply planning, commercial manufacturing, finance, regulatory etc.) to develop strategies for drug supplies and executes the operational activities required for contracting, planning drug supplies, and managing shipments for researchers and patients worldwide.

The Sr. Director, Externally Sponsored Research and Access Programs is accountable for partnering with drug development teams, Global Regulatory Affairs (GRA), Clinical, CM&C, and the broader Product Delivery (PD) Organization to develop supply strategy for clinical drug supplies provided to support Investigator Initiated Research (IIR) and Externally Sponsored Collaborative Research (ESCR) across the Lilly portfolio.

The Sr. Director provides strategic leadership, technical and regulatory expertise in all aspects of supplying Lilly drug products for non-Lilly sponsored clinical trials (CTs). They are accountable for influencing the regulatory filing strategy, and the supply strategy sourcing/vendor strategy for supplying Lilly drug products in alignment with global regulations.

Responsibilities:

Drug Supply and Regulatory Strategy

• Develop and implement drug supply strategies for supported molecules to ensure:
  • Plans are robust with key risks identified and mitigated.
  • Plans are integrated and communicated across the supply chain (includes GRA, packaging, distribution, and clinical teams)
  • Supply chain principles are leveraged.

• Understand current GMP/GDP/GCP regulations impacting the provision of drug products to health care providers and patients, as well as external benchmarking/networking information, to optimize support being provided and increase value to projects/portfolio.
• Ensure establishment of a supply strategy to support the clinical plan that aligns with sponsors’ protocol language and regulatory filing strategy.
• Partner with the asset teams and commercial supply chain to develop and communicate demand forecast and cost considerations as an input into decision making, ensure annual business plan forecast is accurate, monitor forecast to plan and communicate changes, risks, and impact appropriately.
• Deliver the supply strategy for supported molecules:
• Manage and communicate risks through implementation of risk mitigation and contingency plans
• Resolve issues through creative problem solving and managing appropriate communication/escalation.
• Adapt the drug supply strategy as drivers change through execution.
• Support feasibility assessments and contract review as it relates to drug supply and integration of relevant activities.

Influence Clinical Development

• Develop productive partnerships with asset teams and leadership to drive effective communication, build trust and credibility, and improve knowledge of the regulations and external environment as they relate to drug supply planning requirements/process.
• CT Supply Chain Principles, Capability, and Organizational Impact
• Develop deep knowledge of supply chain principles and strategies, supply chain tools and process, and functional construct associated with supply chain and leverage that technical depth to develop and influence asset/trial/department strategy resulting in robust, reliable, efficient, and where needed, innovative, drug supply strategies and plans/execution.
• Influence, lead, and support strategic solutions to increase innovation, efficiency, and productivity.
• Ensure robust metrics are in place to monitor performance and drive operational excellence.

People Development and Capability Building

• Train, coach, and mentor staff to deepen their supply chain expertise, improve their communication and partnership with clinical, CM&C, and the broader PD organization, and drive effective drug supply operations teams. This may be through direct or indirect reporting relationships, as assigned.
• Develop future leaders and supply chain experts in PD.
• Champion a commitment to quality and safety
• Support a culture that fosters inclusion, innovation, and judgement-based decision making.
• If assigned, recruit, develop, and retain an operationally capable workforce skilled in CT //commercial supply chain and its application in clinical development.

Basic Requirements:

• Bachelor’s degree preferred (Supply Chain or relevant health related degree)
• 5-8 years of experience in two or more of the following areas: pharmacy, drug development, clinical drug development, CT material, CM&C, global regulatory affairs, quality, or commercial manufacturing
• Licenses or Certifications (e.g., APICS, Supply Chain Certificate, PM)

Additional Preferences

• Experience working and communicating with third party contract organizations.
• Demonstrated understanding of clinical drug development and CT/commercial drug supply chains
• Exceptional critical thinking, strategy development, and decision-making skills
• Strong knowledge of or experience surrounding end-to-end pharmaceutical supply chain operations & global healthcare practice
• Ability to develop strategies and make decisions in the absence of an obvious answer/approach.
• Demonstrated outstanding internal and external communication and partnership skills, comprehensive knowledge of investigational product requirements (GCP, GMP, GDP), and a strong grasp of the external environment, practices, and technology in the CT supply chain.
• Experience as a supervisor or leading cross functional teams.
• Advanced degree (e.g., MSc, PharmD, PhD) and/or degree in health care, sciences, or supply chain filed.

License/Certificate Requirements: N/A

Language Requirements: Must be fluent in English.

Travel: Occasional travel 5-10%

Position Location: Indianapolis, IN, Lilly Technology Center-North

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 an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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).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.

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