Director - ADME Project Leadership
Eli Lilly
- Indianapolis, IN
- Permanent
- Full-time
- Expertise and working knowledge of ADME-PK properties of large molecule therapeutics (antibodies, proteins, peptides, nucleic acid-based therapies)
- Keen ability to derive and efficiently test ADME and DMPK hypotheses to inform decisions that drive multi-parametric structural optimization.
- Detailed knowledge of current regulatory guidance and expectations including those pertaining to NDA and BLA submissions.
- Strong working-knowledge in fundamental pharmaceutics, pharmacokinetics and ADME principles as it pertains to biological therapeutics, peptides and ADCs.
- Skills to integrate internal and external laboratory and other experimental resources through high quality scientific associations.
- Agile interrogation of diverse data streams (e.g., in silico, in vitro, in vivo) to derive mechanistic understanding of drug action and performance characteristics.
- Working knowledge of large molecule bioanalytical techniques as applied to ADME studies
- Experience in effectively collaborating with key partners including toxicology, clinical pharmacology, clinical PK/PD, discovery biology, chemistry, therapeutic area specialists, protein engineering, and diverse regulatory agencies in a coordinated effort to advance programs to and through clinical testing, as well as experience designing and supporting nonclinical and clinical studies supporting global registration packages.
- Lead and innovate in a multidisciplinary team environment with primary responsibility for ADME studies to support preclinical and clinical development of the Lilly portfolio.
- Design and implement hypothesis driven studies to answer ADME PK/PD and clinical pharmacology questions.
- Integrate ADME, PK and PK/PD endpoints with discovery biology data to define structure activity- and structure-property-relationships to guide drug delivery and optimization strategies.
- Critically evaluate integrated data packages and in due diligence of assets for developability assessment.
- Lead the preparation of regulatory communication and documents to support clinical development (IND), new drug applications (NDA) and BLA and line extensions and interact with regulatory agencies worldwide.
- Build and foster relationships through coaching and mentorship with fellow scientists.
- Possess excellent written and verbal technical communication skills and the demonstrated ability to lead, guide and influence teams in decision making.
- Ph.D. in Biochemistry/Biology/Cell Biology/Pharmacokinetics or a related scientific field
- 5+ years of experience in the industrial discovery and development of large molecule therapeutics.
- Industry (pharma, biotech, etc.) experience with PK/PD modeling of bio-therapeutics.
- Understanding of and experience with immunoassay and/or LC/MS bioanalytical methodology.
- Detailed understanding of pharmacokinetics, ADME and proficiency to communicate theory and concepts clearly.
- Ability to balance multiple projects and handle competing responsibilities.
- Demonstrate strong communication skills with the ability to integrate diverse perspectives, deliver critical messaging, and influence leaders/key partners.
- Collaborative team behaviors and aspiration to build and sustain relationships with R&D customers and the wider scientific community.
- Evaluate and apply innovative PBPK approaches to translate and predict human PK, using modeling as a tool to help generate hypotheses, design better studies, inform clinical plans, and support registration.
- Effectively engage, innovate and collaborate with colleagues and interdisciplinary teams.