ADME Project Leader (Scientific Director)
- Eli Lilly and Company
- Indianapolis, Indiana
- Start date
- Mar 24, 2023
- Clinical, Clinical Development, Science/R&D, Bioanalytical Services, Immunology, Pharmacokinetics
- Required Education
- Position Type
- Full time
- Best Places to Work
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 35,000 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 upbeat, 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 efficiency 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.A high-quality candidate will demonstrate the following:
- 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 understanding in fundamental pharmaceutics, pharmacokinetics and ADME principles as it pertains to biological therapeutics, small molecules, peptides and ADC’s.
- 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.
- Experience in effectively collaborating with key partners. Those key partners would include toxicology, clinical pharmacology, clinical PK/PD, discovery biology, chemistry, therapeutic area specialists, protein engineering, and diverse regulatory agencies. This coordinated effort will advance programs to and through clinical testing. Experience needed in designing and supporting nonclinical and clinical studies supporting global registration packages.
- Lead and innovate in a multidisciplinary collaborative 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
- 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
- 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, 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 and the proven track record to lead, guide and influence teams in decision making
- PhD in Biochemistry/Biology/Cell Biology/Pharmacokinetics or a related scientific field with extensive training in the field of drug metabolism and disposition or clinical pharmacology
- 5+ years proven experience in the industrial discovery and development of biological and/or small 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
- Experience in drug discovery and development
- Experience authoring regulatory and technical reports
- Collaborative team behaviors and aspiration to build and sustain relationships with R&D customers and the wider scientific community
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).
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