Associate Director/Director, Clinical Delivery Capabilities - EMP 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, HealthcareIndustries

Requirements

Knowledge of ICH and quality guidelines for successful delivery of portfolio and clinical trials
Business acumen, process knowledge, and influence to lead process and quality improvement efforts
Ability to seek knowledge from internal and external sources to drive strategic discussions and recommendations for efficiencies and continuous improvement
Expertise in exploratory and biopharmaceutics clinical development processes and methodologies
Awareness of regulatory issues and trends relevant to assigned portfolio

Responsibilities

Provide operational leadership to support exploratory and biopharmaceutics clinical development, delivering knowledge, expertise, standard templates, and technology across the organization
Lead activities supporting study development and execution, including establishing networks with key support areas, owning updates to corporate systems (e.g., CT Registry, Vault Clinical, eTMF), and managing contracting elements
Provide leadership in business interactions with TPO partners, execute the clinical development portfolio, lead issue escalation, relationship management, vendor and clinical research unit assessments
Provide leadership in business processes supporting early phase development and establish expertise on key business systems
Review established procedures across multiple subject areas, contribute to strategic direction of cross-functional systems and processes, sponsor improvement initiatives for efficiency and value
Ensure cross-functional process alignment internally and externally, act as key resource to internal governance committees on processes
Establish optimal networks with Quality, Clinical Information and Process Automation, and L&D organizations to ensure compliance with Quality and Regulatory requirements
Drive definition of metrics or measures to quantify exploratory activities (systems, metrics, and reporting)

Skills

Key technologies and capabilities for this role

Clinical DevelopmentStudy DevelopmentStudy ExecutionCross-Functional LeadershipProcess ImprovementICH GuidelinesQuality ManagementMetrics and ReportingBiopharmaceuticsPortfolio Delivery

Questions & Answers

Common questions about this position

What is the employment type for this role?

This is a full-time position.

Is this role remote or does it require working from a specific location?

This information is not specified in the job description.

What key skills and expertise are required for this position?

The role requires operational leadership in clinical development, knowledge of ICH and quality guidelines, business acumen, process knowledge, influence for process improvements, and expertise in business systems like CT Registry, Vault Clinical, and eTMF.

What is the company culture like at Eli Lilly?

Eli Lilly unites caring with discovery to make life better for people around the world, puts people first, and emphasizes giving best effort to work while contributing to communities through philanthropy and volunteerism.

What makes a strong candidate for this Associate Director/Director role?

Strong candidates will have operational leadership experience in clinical development, expertise in ICH guidelines and quality processes, business acumen to drive efficiencies, and the ability to build networks and lead cross-functional interactions.

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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