Sr. Director Clinical Development – Lilly Gene Therapy, Sensory

Chester, Maryland, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Pharmaceuticals, Biotechnology, Gene TherapyIndustries

Requirements

Candidates must possess a Master's degree or an advanced degree (PharmD, PhD, etc.) in the Life Sciences and have a minimum of ten years of pharmaceutical and/or clinical experience. Prior experience in rare disease, otology, audiology, gene therapy, cellular therapy, or medical device is a plus. A proven track record of successfully conducting or supporting global clinical trials and a comprehensive understanding of the drug development and approval process, including clinical trial design, are required.

Responsibilities

The Sr. Director, Clinical Development will lead the development of clinical strategies and plans for assigned programs, ensuring integration with program targets and goals. They will collaborate with cross-functional teams to support clinical programs and represent clinical development in decision-making and problem-solving. This role involves providing leadership and guidance to the clinical development team, serving as the clinical/scientific representative for studies, and overseeing the scientific execution of protocols. Responsibilities also include supporting clinical operations, reviewing and interpreting clinical trial data, contributing to publications, and authoring/reviewing clinical and regulatory documents. The individual will act as a clinical representative in internal and external meetings.

Skills

Clinical Trial Management

Clinical Strategy Development

Clinical Program Management

Global Clinical Trials

Scientific Execution

Leadership

Mentorship

Cross-functional Collaboration

CRO Management

SOP Development

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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