ADME Project Leadership for Genetic Medicines

Role Summary

ADME Project Leadership for Genetic Medicines. Lead discovery and clinical development programs for Lilly's genetic medicines portfolio, including siRNAs, ASOs, mRNAs, gene editing, and gene therapy. Collaborate with cross-functional teams to design and interpret ADME/PK/PD studies, mentor junior scientists, and drive delivery strategies and regulatory communications. This position is based in Boston, MA.

Responsibilities

• Lead and innovate in a multidisciplinary team environment with primary responsibility for ADME studies to support preclinical and clinical development of the Lilly genetic medicines portfolio
• Design, implement, and interpret hypothesis-driven studies to inform key ADME, PK/PD, and toxicokinetic (TK) questions
• Integrate ADME, PK and PK/PD endpoints with discovery chemistry and biology data to guide preclinical drug design, optimization, and delivery strategies
• Engage, innovate, and collaborate with cross-functional colleagues and interdisciplinary teams
• Lead the preparation of ADME portions of regulatory communications and documents to support clinical development, new drug applications, and line extensions and interact with global regulatory authorities
• Mentor and support junior scientists and build relationships through coaching and mentorship with fellow scientists at all levels
• Possess excellent written and verbal technical communication and the ability to constructively lead, guide and influence teams

Qualifications

• Required: Ph.D. in Biochemistry/Biology/Pharmacokinetics/Bioengineering/Pharmacology or a related scientific field
• Greater than five years of experience as a scientist in a pharmaceutical and/or biotechnology company in a role related to ADME or PK/PD
• Strong working knowledge in fundamental pharmaceutics, pharmacokinetics/pharmacodynamics, and ADME principles—especially as they relate to novel genetic medicine therapeutic modalities
• Understanding of pharmaceutical regulatory guidance and expectations
• High learning agility and ability to articulate and efficiently test ADME and DMPK hypotheses for complex novel molecules

• Preferred: Knowledge of DMPK and/or bioanalytical considerations for gene editing therapeutics
• Experience with PK/PD modeling and simulation
• Experience with targeted delivery and biodistribution of oligonucleotides and/or gene therapies
• Understanding of and experience with PCR, immunoassay, and/or LC/MS bioanalytical methodology

Education

• Ph.D. in Biochemistry/Biology/Pharmacokinetics/Bioengineering/Pharmacology or a related scientific field

Skills

• ADME/DMPK hypothesis testing and data integration across in silico, in vitro, and in vivo datasets
• Regulatory documentation and cross-functional collaboration
• Mentorship and leadership within scientific teams