Scientific Director - ADME Project Leadership for Biologics

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life‑changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

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 (e.g. 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 for across experimental and drug modalities including biologics / antibodies.
• 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 (e.g. 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.

Basic Qualifications

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.

Additional Skills / Preferences

Accommodation Statement

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

EEO Statement

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Employee Resource Groups

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include : Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Compensation and Benefits

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $168,000 - $294,800. Full‑time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company‑sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and / or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well‑being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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