[Remote] Associate Director - Oncology - Clinical Laboratory Sciences at Eli Lilly and Company

Chester, Maryland, United States

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Not SpecifiedCompensation

N/AExperience Level

N/AJob Type

Not SpecifiedVisa

N/AIndustries

Requirements

Bachelor’s degree with at least three years of experience in clinical drug development, preferably in oncology, with a focus on laboratory sciences and diagnostics and a solid scientific background
Advanced degree (e.g. MSc, PhD) in a scientific or health care field strongly preferred
Companion Dx development experience and sample management
Experienced in clinical diagnostic and laboratory needs in oncology in a regulated setting
Demonstrated analytical, technological, and project management expertise
Ability to set and implement strategies and plans to improve complex oncology drug development processes and capabilities

Responsibilities

Develop clinical lab, diagnostic, and biomarker strategies for trials and compounds
Collaborate with business and therapeutic teams to establish and document clinical laboratory and diagnostic strategies
Oversee project management, including budgets, timelines, risks, and vendor performance
Engage with Research teams (CDDA, ADME/PK, Toxicology, Biomarker, Companion Dx, Laboratory and Experimental Medicine) at an early stage
Shape protocol design for both CLS operations and patient/site requirements
Execute clinical and biomarker sampling plans for clinical trials
Maintain accurate and concise inventory of research and clinical/preclinical samples
Participate in budget planning activities with CBLDx project managers
Offer expert consultation with tracking and resolving discrepancies with study team, sites, or CRO vendors
Promote knowledge sharing across the organization to enhance clinical design and improve processes
Identify key functional capability gaps and address them early to accelerate portfolio delivery
Provide oversight of central labs, CRO’s, and data deliverables
Participate in regulatory audits and other for submission activities
Serve as a therapeutic and clinical laboratory expert to the CLA’s and provide coaching within the organization

Skills

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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