Associate Director - Clinical Development Program Lead, Clinical Delivery - 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

Leads the development of the clinical asset strategy for phase 1 leveraging quality decision making principles
Understands assigned therapeutic area including trial designs, risks and execution challenges and best practices
Provides consultation to the project team for clinical and regulatory documents such as study protocols, Investigator Brochures (IBs), risk profiles, annual reports, briefing documents, New Drug Applications (NDAs), safety updates, clinical study reports (CSRs), abstracts, publications, and manuscripts
Stays up to date with current body of knowledge of relevant disease states/targets, competitors, and industry trends and best practices
Maintains knowledge of operational requirements to effectively plan exploratory and biopharmaceutics clinical development studies and submissions e.g., FHD (First Human Dose) requirements, detail of operations to deliver critical path studies and submissions
Leads and has expertise in the implementation and integration of clinical project management processes and tools

Responsibilities

Lead the creation and execution of the exploratory and biopharmaceutics clinical development plans at a molecule level, with technical leadership and operational oversight of clinical research trials within the development plan
Plan and deliver exploratory and biopharmaceutics clinical trial and submission milestones on time and on budget throughout the molecule lifecycle
Responsible for all aspects of global clinical trial operations within the plan, as the single operational point of contact for trials from design through execution, including timeline creation and management, outsourcing plan, vendor management (including oversight of the operational deliverables), and budget management
Seek knowledge from internal and external sources and use this information to shape development plans and continuous improvement opportunities
Works with Third Party Organizations (TPOs) to execute the defined clinical strategy, overseeing key trial deliverables
Develops and maintains up-to-date clinical plan timelines and process maps (if appropriate) ensuring communication of progress to the broader molecule team
Partners with the financial organization, cross-functional partners, and geographies, to develop and manage the overall clinical budget for the molecule level book of work including initiation and management of the change process
Proactively identifies and communicates clinical risk assessment and mitigation/contingency plans within team and to functions, affiliates, and leadership
Accountable and responsible for oversight of clinical trial operations and delivery of clinical project milestones on time, on budget
Create and manage implementation timeline

Skills

Clinical Development

Clinical Trials

Program Management

Vendor Management

Budget Management

Trial Operations

Outsourcing

Timeline Management

Biopharmaceutics

Global Clinical Operations

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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