Scientific Director - Project Leadership 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

PharmaceuticalsIndustries

Requirements

Ph.D. degree in Pharmacokinetics, Pharmacology, Pharmaceutics, Biochemistry, or related field
6 years or more of extensive training in the field of drug metabolism and disposition or clinical pharmacology
Experience in drug discovery and development across a variety of therapeutic areas
Experience with 1+ modality (small molecules, biologics/antibodies, peptides, ADCs, siRNAs, gene therapies, and other complex modalities) and/or deep expertise with one modality

Responsibilities

Accountable for the delivery of scientifically integrated data packages to guide compound selection, study design, portfolio decisions, and regulatory submissions
Partner with cross-functional colleagues in both Discovery and Development (eg. Toxicology, Pharmacology, Chemistry, Clinical PK/PD, Clinical Pharmacology, Regulatory, and Medical) to assess drugability and optimize ADME properties to deliver drug candidates to the clinic, as well as to design and support nonclinical and clinical studies, supporting global registration packages
Lead R&D initiatives to grow and develop ADME/DMPK capabilities across experimental and drug modalities including small molecules, biologics/antibodies, peptides, ADCs, siRNAs, gene therapies, and other complex modalities
Integrate in vitro, in vivo, and in silico ADME data with Biology and Chemistry understanding to define structure-activity- and structure-property-relationships and deliver favorable molecular and experimental design strategies
Prepare data packages and develop content in regulatory documents (eg. IB, IND, IMPD, NDA/BLA, etc.) to support global regulatory submissions (including sections 2.6.4./non-clinical pharmacokinetics and 2.7.2./clinical pharmacology) and correspondence as well as represent ADME in face-to-face discussions with regulators
Guide junior, peer, and upper level scientists in best and modern practices of multi-property optimization through the use of mechanistic ADME principles
Effectively partner to apply innovative PBPK approaches to translate and predict human PK, inform clinical plans and support registration
Communicate the value of mechanistic ADME approaches both internally within R&D and externally including regulatory agencies
Build a strong external network (e.g. academia, consortia) and keep up to date with emerging literature and science in the area

Skills

DMPK

ADME

Pharmacokinetics

In Vitro

In Vivo

In Silico

Small Molecules

Biologics

Antibodies

Peptides

ADCs

siRNAs

Gene Therapies

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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