Director - ADME Project Leadership

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.

This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Lilly’s Drug Disposition team is searching for an experienced pharmaceutical scientist to lead the application of absorption, distribution, metabolism, excretion (ADME) science to advance our portfolio. Working on cross-functional teams, our diverse group is multidisciplinary, applying in vitro, in vivo, and in silico approaches to mechanistically study the pharmacokinetics, absorption, and disposition of small molecules, biologics/antibodies, peptides, ADCs, siRNAs, gene therapies, and other complex modalities.

You will serve as technical leader within the department and across portfolio cross-functional teams. This role will require engaging in experimental design and data interpretation to deliver the discovery and development portfolio of investigational targets and novel therapeutics. We are passionate about making an impact in the lives of our patients. Consider joining our efforts.

• 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.
• 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.

Ph.D. degree in Pharmacokinetics, Pharmacology, Pharmaceutics, Biochemistry, or related field with 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.
• Deep experience with small molecules preferred.
• Additional experience with at least one other modality desired, such as biologics/antibodies, peptides, ADCs, siRNAs, gene therapies, and other complex modalities.
• Detailed understanding of pharmacokinetics, ADME, drug interactions and proficiency to communicate theory and concepts clearly.
• Ability to balance multiple projects and handle competing responsibilities.
• Experience with modeling software (e.g. SimCYP, Gastro Plus, NONMEM, Matlab, etc.).
• Demonstrate strong communication skills…