Director - ADME Project Leadership

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Job description

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.

Our diverse ADME team is seeking an experienced, dynamic scientist interested in the discovery and clinical development of medicines including small molecules, biologics, peptides, oligonucleotides, and gene therapies. If you have a talent for finding creative solutions to complex problems, apply today! We want you on our team.

Our scientifically agile team works collaboratively to deliver novel therapies to patients. We support one another through shared-learning and mutual-responsibility for the enterprise of making medicines. Ours is a flexible environment where each team member can optimize their productivity while being mindful of wellness. This enables each of us to grow our careers as well as the scientific field in our search for safe and effective medicines. Please connect with us if you are a motivated and collaborative scientist looking for an opportunity to innovate at the forefront of novel therapies to improve the lives of patients. This role is based in Indianapolis, IN.

A high-quality candidate will demonstrate the following:

• 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.

Lilly-ADME seeks a skilled, experienced ADME scientist who will:

• 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.

Basic Requirements

• 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.

Additional Skills/Preferences

• 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.

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.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.

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