Scientific Director ADME - Novel Modalities in Cambridge, Massachusetts
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.
At Lilly, we serve an extraordinary purpose. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world’s greatest health challenges.
Do you possess a unique passion for the science of drug discovery and development? Our diverse ADME team is seeking a hardworking scientist experienced in the discovery and clinical development of biological therapeutics including peptides, fusion proteins, mAbs, RNAs and oligonucleotides. If you have a talent for finding creative solutions to complex problems, apply today! We want you on our team.
We are a scientifically agile team comprised of dedicated scientists who work to deliver novel biological 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 biotherapies 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 contemporary regulatory guidance's 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.
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 including toxicology, clinical pharmacology, discovery biology, therapeutic area specialists, protein engineering, and diverse regulatory agencies in a coordinated effort to advance programs to and through clinical testing.
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, PK/PD and toxicokinetic (TK) questions.
Integrate ADME, PK and PK/PD endpoints with discovery biology data to define structure activity- and structure-property-relationships to guide protein engineering and drug delivery and optimization strategies.
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 drugs applications 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 demonstrated ability to lead, guide and influence teams in decision making.
Ph.D. in Biochemistry/Biology/Cell Biology/Pharmacokinetics or a related scientific field and 5+ years of experience in the industrial discovery and development of biological 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.
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At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!