Eli Lilly and Company

Senior Director, Clinical Biomarker Development

Chester, Maryland, United States

Not SpecifiedCompensation
Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Healthcare, Pharmaceuticals, BiotechnologyIndustries

Senior Director, Clinical Biomarker Development

Employment Type: Full time

Position Overview

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.

The Senior Director, Clinical Biomarker Development will integrate biomarker research and clinical development, and will be accountable for the design, delivery, and execution of biomarker and diagnostics plans in early phase clinical programs. Programs include early proof of concept through registrational studies in a variety of targets. The role involves cross-functional collaborations across Biomarker Operations, Clinical Development and Translational Medicine as well as Diagnostic Medical Affairs. Responsibilities encompass strategic planning to optimize the clinical and registrational utility of Biomarker development plans for assigned projects as well as management and career development of biomarker scientists. This person must thrive in a fast-paced, team-oriented environment and be adaptable to rapidly changing priorities.

Responsibilities

  • Oversee the integration of biomarker and diagnostic development plans in clinical development with the current oncology treatment landscape, registrational and launch needs for the asset and with external competitors.
  • Ensure individual biomarker scientist plans are developed and implemented optimally according to the strategic needs of the assets and are aligned to company positions and guidelines.
  • Create and foster strong strategic partnerships with colleagues that include Biomarker Operations, pre-Clinical Development, Clinical Operations/Development, Dx Regulatory Affairs and Dx Medical Affairs.
  • Apply Biomarker Development strategy to the design and interpretation of clinical trials.
  • Provide strategic input into data analysis, and engage in critical thinking, to deliver key data generation and interpretation essential for decision making as well as public scientific disclosure.
  • Lead integration with functional teams such as discovery, translational medicine, data science, clinical science etc. to ensure timely analysis, interpretation and disclosure of data to support development of our oncology pipeline.
  • Demonstrate substantial and relevant knowledge of scientific and medical literature with genomics and biomarker expertise and its application to strategic drug development and registration.
  • Apply scientific and operational knowledge to identify and analyze problems and information of considerable complexity and implement effective plans and solutions.
  • Collaborate with operational teams to ensure cohesive planning and strategy.
  • Ability to prioritize effectively and meet multiple deadlines successfully with attention to detail, setting high performance standards.
  • Proactively generate ideas for improvements and take action to solve problems and achieve goals beyond what is required.

Requirements

  • Basic Qualifications:
    • MD or PhD required
    • 10+ years of biomarker experience within an academic or industry setting
  • Additional Skills/Preferences:
    • Strong preferably within laboratory-based cancer research or clinical trials is preferred.
    • Clinical trial expertise along with experience in oncology with drug development highly desirable.
    • Demonstrated ability to work well with other accomplished professionals within and across functions/teams.
    • Scientific and analytic ability.
    • Ability to think strategically and tactically while working effectively in a multifunctional team.
    • Excellent organization and communication skills.
    • Proven ability to evaluate, interpret and present complex scientific data.

Company Information

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.

Skills

Biomarker Development
Clinical Development
Oncology
Strategic Planning
Project Management
Team Leadership
Translational Medicine
Diagnostics

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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