Jobs
>
Indianapolis

    Director - ADME Project Leadership - Indianapolis, United States - Eli Lilly and Company

    Eli Lilly and Company
    Eli Lilly and Company Indianapolis, United States

    4 weeks ago

    Default job background
    Full time
    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. 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 ( ) 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. #WeAreLilly

  • Hamlyn Williams

    Operational Readiness Project Manager

    3 weeks ago

    Hamlyn Williams Indiana, United States

    The Operational Readiness Project Manager is responsible for managing the delivery of operational readiness aspects of the facility. This role works in partnership with front line resources, leadership, and project stakeholders to ensure site deliverables to support startup are a ...

  • Mace

    Construction Manager

    4 weeks ago

    Mace Indianapolis, United States Full time

    At Mace, our purpose is to redefine the boundaries of ambition. We believe in creating places that are responsible, bringing transformative impact to our people, communities and societies across the globe. To learn more about our purpose, culture, and priorities, visit our . · W ...

  • Eskenazi Health

    supervisor, translation services

    3 hours ago

    Eskenazi Health Indianapolis, United States FT w/ben - No Perf 16

    The Supervisor, Translation Services leads all aspects of written translations for Eskenazi Health. This includes contributing to the accurate translation of documents, creating and updating team resources, managing the workflow of all projects, providing team trainings and ensur ...

  • WSP

    Senior Roadway Engineer

    4 days ago

    WSP Indianapolis, United States Regular, Full

    This Opportunity · WSP is seeking to grow its Transportation team and is currently searching for a Senior Roadway Engineer for our Indianapolis, IN office. Be involved in projects with our Civil Team and be a part of a growing organization that meets our client's objectives and s ...

  • 619 Recruiting

    Construction Project Manager

    1 week ago

    619 Recruiting Indianapolis, United States Direct Hire

    Commercial Construction Project Manager · Our client is a leading commercial construction firm committed to delivering high-quality projects on time and within budget. They are looking for a motivated and experienced Commercial Construction Project Manager to join their dynamic t ...

  • BMWC

    Project Manager

    4 weeks ago

    BMWC Indianapolis, United States

    · Project Manager (Mechanical Construction) · Driven by Vision | Powered by Passion · Location: Indianapolis, IN · Company Overview: Working for global leaders in the aerospace, chemical, steel, pharmaceutical, oil & gas, power generation, and semiconductor industries, BMWC ...

  • Global Channel Management, Inc

    Remote Healthcare Project Mgr

    2 weeks ago

    Global Channel Management, Inc Indianapolis, Indiana, United States Permanent

    Remote Healthcare Project Mgr needs 5+ years experience in pharma, healthcare · Remote Healthcare Project Mgr requires: · Bachelors degree preferably in a health-related, scientific or engineering field and a minimum of 5 years of experience; · Advanced degree or certifications ( ...

  • Selectek

    Transportation Project Engineer

    5 days ago

    Selectek Indianapolis, United States

    · We are looking for a Transportation Project Engineer in Indianapolis IN. This is a 6-month contract to direct opportunity. · Required: · Lead transportation design calculations/reports/plan preparation/roadway modeling · Assist office leadership in the preparation of proposal ...

  • Cummins Inc.

    Internal Controls Manager

    4 weeks ago

    Cummins Inc. Indianapolis, United States

    Description · We are looking for a talented Internal Controls Manager to join our team specializing in Internal Controls for our Corporate Organization in Indianapolis, Indiana. · In this role, you will make an impact in the following ways: · Manage the execution of business pr ...

  • Per Sé Group

    Asphalt Superintendent

    3 weeks ago

    Per Sé Group Indiana, United States

    Job Description · Per Sé Group is working with a leading heavy civil contractor looking to hire a Construction Superintendent in Indianapolis. The ideal candidate has roadway construction and paving experience with asphalt and concrete. INDOT experience is preferred. · Responsibi ...

  • iRiS Recruiting Solutions

    Superintendent

    13 hours ago

    iRiS Recruiting Solutions Indiana, United States

    Role: Superintendent (Lead) · Location: Greater Indianapolis (All local work) · Travel: None · One of the top ENR ranked general contractors in Indianapolis is looking for a Lead Superintendent. This GC works primarily in the commercial sector with a growing backlog of local work ...

  • Lilly

    Sr Principal Scientist

    4 weeks ago

    Lilly Indianapolis, United States Full time

    We're looking for people who are determined to make life better for people around the world. · Position Brand Description: · Provides technical leadership for drug product manufacturing processes under development and in commercial production in the Dry Product Network. · Key Ob ...

  • Lilly

    Engineer - Engineering Tech Center - Parenteral Network

    3 weeks ago

    Lilly Indianapolis, United States Full time

    We're looking for people who are determined to make life better for people around the world. · Overview: · At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer ...

  • Lilly

    Associate Director-Capital Project Procurement

    4 weeks ago

    Lilly Indianapolis, United States Full time

    We're looking for people who are determined to make life better for people around the world. · For over 140 years, Lilly has been at the forefront of manufacturing medicines that improve lives worldwide. Our commitment to excellence drives us to use sophisticated technologies an ...

  • Lorven Technologies

    Role - Senior Project Manager - Location: Indianapolis, IN (Hybrid Role) - Contract position

    4 weeks ago

    Lorven Technologies Indianapolis, United States C2C, W-2, 1099, C2H, Part time, Full time, Other, Intern, Seasonal, Contract, W2 - Hourly, W2 with Benefits, Project Staff, Perm Placement, Internal Staff

    Position: Senior Project Manager. · Location: Indianapolis, IN (Hybrid Role) · Contract · *Local Candidates Only · *Both Webcam and In-person · Excellent communication skills required. · ln this position, you will collaborate with senior management, stakeholders and the team ...

  • Employment Resource Group, Inc.

    Vice President of Construction Operations

    3 weeks ago

    Employment Resource Group, Inc. Indiana, United States

    Position Summary: We are seeking a dynamic Vice President of Construction Operations to lead heavy industrial construction projects in Lafayette, Indiana. This executive role is designed for a seasoned professional with over a decade of experience in managing the complete lifecyc ...

  • Medxcel

    Architectural Design Manager

    1 week ago

    Medxcel Indianapolis, United States Full time

    Medxcel is here to lead the transformation of healthcare facilities management by incorporating a new approach to providing services. Created by healthcare, for healthcare, we have a dedicated focus on our people and customers, as well as providing tools, processes, support resou ...

  • WSP

    Civil Engineering Intern

    6 days ago

    WSP Indianapolis, United States Intern, Full

    This Opportunity · Nationally recognized as a Top 100 Internship Program, WSP USA hosts hundreds of interns across the United States to gain hands-on, meaningful work experience to enhance their education and professional aptitude. Our interns gain exposure to real projects while ...

  • Lilly

    Associate Director- Quality Control

    3 weeks ago

    Lilly Indianapolis, United States Unspecified

    We're looking for people who are determined to make life better for people around the world. · The Associate Director – Quality Control is responsible for managing the activities of Quality Control personnel. The Assoc. Director Quality Control must balance coaching a technical s ...

  • Carrier

    Senior Manager Program Management

    1 week ago

    Carrier Indianapolis, United States Full time

    Country: · United States of AmericaLocation: · CAI22: Carrier - Indianapolis 30 S Meridian St, Suite 500 , Indianapolis, IN, 46204 USACarrier is the leading global provider of healthy, safe and sustainable building and cold chain solutions with a world-class, diverse workforce ...