Director ExploR&D PK/PD

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.Lilly Catalyze360, our external innovation organization dedicated to biotech collaboration, is comprised of three pillars: (1) Lilly Ventures, which provides capital directly to biotechs and via a fund-of-funds investment strategy; (2) Lilly Gateway Labs, a best-in-class network of biotech incubators; and (3) ExploR&D, which offers Lilly’s research and development expertise and solutions to biotechs.The ExploR&D mission is unleashing Lilly’s world-leading capabilities and know-how to accelerate the science of our collaborators to value inflection, and to patients. Through a unique model that mixes dedicated headcount and flexible use of functional and therapeutic area expertise, we will provide the knowledge and services to enable our collaborator’s programs, ensuring Lilly is networked with the brightest scientific minds around the world, positioning Lilly as a partner of choice for biotechs to fuel our industry-leading pipeline and creating value for the scientific ecosystem. We are seeking a Pharmacokinetics/ Pharmacodynamics (PK/PD) Director/Sr Director to join our ExploR&D team in accelerating drug development.The ExploR&D PK/PD Director/Sr Director will serve as functional leader for programs from discovery through and including clinical proof-of-concept. For assigned projects, the PK/PD Director/Sr Director is responsible for utilizing the principles of quantitative pharmacology to ensure the relevance and rigor of preclinical and clinical strategies, plans and execution. This role is preferably based in Boston, MA or Indianapolis, IN. Remote option is also possible.If you have a talent for finding creative solutions to have impact on the biotech ecosystem, apply today! We want you on our team.Key responsibilities:Provide strategic and scientific leadership in drug metabolism and pharmacokinetics (DMPK) and clinical PK/PD to support the selection of the right molecule, dose, patient population, and development strategies for projects from discovery to early development phases.Responsible for the consistency, quality, compliance, and timeliness of DMPK and clinical PK/PD deliverables, such as IND-enabling DMPK package, human PK and dose projection, clinical protocols, clinical PK/PD analysis, and PK/PD sections of investigator brochures, study reports, regulatory documents, and other documents in accordance with general standards, guidelines, and procedures.Critically evaluate integrated data packages in due diligence of assets for developability assessment.Lead, network, identify and manage DMPK, PK/PD, bioanalysis, and general pharmacometric outsourcing/third party vendor relationships and deliver project milestones on time, on budget, and within scope.Establish key cross-functional collaborations with toxicology, medical, clinical operations, regulatory affairs and external partners.Minimum requirements:PhD degree in Pharmaceutical Sciences, Pharmacology, Pharmacokinetics, Drug Metabolism, Chemistry, Biochemistry or a related scientific field.At least 5 years of relevant drug discovery and development experience from industry, regulatory, consulting within the field of DMPK, PK/PD, clinical pharmacology, or closely related field.Additional Skills/Preferences:Strong working knowledge in fundamental pharmaceutics, pharmacokinetics and ADME principles.Demonstrated excellent understanding of clinical pharmacology (PK, PD and pharmacometrics) principles, proficient in PK computer software.Knowledge and experience in advancing and implementing model-informed approaches in drug discovery and development.Understanding and/or working knowledge of bioanalytical techniques including immunoassays and/or LC/MS.Experience in a variety of therapeutic areas (eg, immunology, neuroscience, endocrinology) with proven agility to apply scientific principles across phases and diseases.Expertise and working knowledge of broad range of drug modalities (small molecule, peptide, antibodies, antibody-drug conjugates, nucleic acid-based therapies).Ability to prioritize resources, balance multiple projects, and handle competing responsibilities.Demonstrated leadership abilities/behaviors, particularly entrepreneurial mindset, strategic thinking and teamwork and experience in working in a cross functional setting and matrix environment.Excellent written and verbal technical communication skills and the demonstrated ability to lead, guide and influence teams in decision making.Ability to communicate with variety of functions and drive problems to resolution within cross-functional teams (eg, including medical, toxicology, statistics, and others).Ability to communicate complex scientific concepts to a wide variety of audiences.Other Considerations:Willing to engage in domestic and international travel to the degree appropriate to support the business of the organization. Time expected for travel approximately 20% in a given year (25% for remote employee).

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