Associate Director - Clinical Central Services & Innovation at Eli Lilly and Company

Indianapolis, Indiana, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Healthcare, Clinical ResearchIndustries

Requirements

Expertise in global regulations governing decentralized clinical research, including distribution of pharmaceutical products and trial supplies
Strong business and financial acumen
Ability to develop business strategies, processes, and technology related to clinical central services & innovation
Experience in vendor management and collaboration
Knowledge of clinical trial operations, including pharmacy services, medical benefit coverage, direct-to-patient delivery, and community-based research support
Capability to maintain inspection readiness and support internal/external inspections

Responsibilities

Serve as Operational Lead to develop business strategies, processes, and technology for clinical central services & innovation
Partner with study teams, external partners, and vendors to develop innovative solutions for trial activities at alternative site locations (e.g., patient home, community health center, HCP locations)
Partner with Clinical, Regulatory, Product Delivery, Quality, Procurement, Finance, BU’s, and other MDU functions to understand trial requirements and patient needs, informing capability decisions
Provide expertise on global regulations for decentralized research at community-based and alternative sites, and develop strategic compliance plans
Continuously maintain inspection readiness, participate in inspections, and support institutions/investigators/alternative sites
Drive benchmarking, continuous improvement, shared learning, and process expertise across teams
Develop critical success factors for pilot programs/projects and monitor progress for decision-making
Drive operations strategy and implementation for capabilities, including processes for patient services like pharmacy, medical benefits, direct-to-patient delivery, and community support
Oversee partnering with clinical & design organizations and participate in maintenance/interpretation of decentralized trial and clinical trial material regulations, aligning strategies globally
Manage vendors and coordinate efforts across clinical capabilities teams
Understand business and financial acumen to minimize risk, delays, and interruptions

Skills

clinical trial operations

strategic planning

pharmacy services

telemedicine

virtual trial orchestration

patient recruitment

site management

digital devices

process implementation

cross-functional partnering

Eli Lilly and Company

Develops and delivers prescription medicines globally

About Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.

Indianapolis, IndianaHeadquarters

1876Year Founded

$1,180.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Competition from Novo Nordisk's Ozempic may impact tirzepatide's market share.

Potential construction delays in Indiana could affect GLP-1 drug production timelines.

Regulatory challenges may hinder Kisunla's expansion in new Alzheimer's markets.

Differentiation

Eli Lilly's rich history includes the first life-saving insulin treatment.

Lilly's strategic partnerships enhance its position in neurodegenerative disease treatments.

FDA approval of Zepbound opens new therapeutic markets for sleep disorder treatments.

Upsides

Lilly's $9 billion complex in Indiana boosts GLP-1 drug production capacity.

Kisunla's approval in China expands Lilly's Alzheimer's treatment market in Asia.

Collaboration with EVA Pharma enhances Lilly's reputation as socially responsible.

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