Dawn Gardner

Dawn Gardner Email and Phone Number

Vice President , Program Management @ Immunovant
Indianapolis, IN, US
Dawn Gardner's Location
Indianapolis, Indiana, United States, United States
Dawn Gardner's Contact Details
About Dawn Gardner

Global Drug Development (all phases and Therapeutic areas)Global Team LeadershipGlobal Functional ManagementProject ManagementRegulatory interactions (FDA, CHMP, briefing documents, Type A meetings, End of Phase 2 meetings, Advisory Committee Meetings)CT Manufacturing, Packaging, Distribution and AncillariesSAP implementationClinical Project ManagementClinical Development

Dawn Gardner's Current Company Details
Immunovant

Immunovant

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Vice President , Program Management
Indianapolis, IN, US
Website:
immunovant.com
Employees:
362
Dawn Gardner Work Experience Details
  • Immunovant
    Vice President , Program Management
    Immunovant
    Indianapolis, In, Us
  • Syneos Health
    Vice President, Clinical Development
    Syneos Health May 2023 - Present
    Morrisville, Nc, Us
  • Syneos Health
    Executive Director, Clinicaloperations
    Syneos Health Feb 2022 - May 2023
    Morrisville, Nc, Us
  • Oncobay Clinical
    Executive Director, Clinical Operations
    Oncobay Clinical Jun 2021 - Feb 2022
    Raleigh, Nc, Us
  • Syneos Health
    Sr. Project Director
    Syneos Health Jun 2019 - May 2021
    Morrisville, Nc, Us
  • Indiana University School Of Medicine
    Program Manager Multiple Myeloma Precision Health Initiative Dept Of Hematology/Oncology
    Indiana University School Of Medicine Jan 2018 - Jun 2019
    Indianapolis, In, Us
  • Eli Lilly And Company
    Sr. Director Ct Material Manufacturing And Services And Supply Chain Systems
    Eli Lilly And Company Apr 2012 - Dec 2018
    Indianapolis, Indiana, Us
    Responsible for the development and implementation of near and long term strategy for CT Manufacturing including the management of an extensive external network. Responsible for the global CT Manufacturing budget an he management and development of staff. Accountable for in time delivery of NDP globally and in compliance with GMPs. Responsible for leading a large cross functional team, including eternal partners to transition the entire CT Supply Chain to SAP. This includes assessment of system requirements, system build, modification of all internal business processes, training testing and implementation.
  • Eli Lilly And Company
    Sr. Director Global Ct Manufacturing, Packaging And Distribution
    Eli Lilly And Company Dec 2015 - Dec 2017
    Indianapolis, Indiana, Us
    Lead and develop a global staff and large cross functional budget Responsible for the development and implementation of near term and long term strategy for CT Manufacturing, Packaging, Distribution and Ancillaries, including the management of an extensive external partner networkLed the opening of Hubs and Depots Responsible for the on-time on budget delivery of global clinical supplies including ancillary supplies
  • Eli Lilly And Company
    Senior Director, Late Phase Development Leader
    Eli Lilly And Company 2007 - 2012
    Indianapolis, Indiana, Us
    Managed a large staff of physicians, project managers and clinical staff. Led the development of strategic business plans and global drug development plans for Ph 2 and Ph 3 assets, large and small molecules, in the Autoimmune, Neuroscience and Endocrine therapeutic areas. Responsible for budgets and on time delivery. Part of a team leading a merger and acquisition with personal responsibility for the development of a strategic sourcing and resource management plan, asset transition, site closure and seamless transition of roles and responsibilities to ensure on time delivery of the project. Led a team through preparation of FDA and CHMP briefing documents, preparation for regulatory interactions and Advisory Committee Meetings
  • Eli Lilly And Company
    Pharmaceutical Project Manager
    Eli Lilly And Company 2001 - 2007
    Indianapolis, Indiana, Us
    Led multiple cross functional early phase development teams in Oncology, Neuroscience, Musculoskeletal and Cardiovascular therapeutic areas. Accountable for the creation of cross functional development plans and budgets and on time delivery. Supervisory responsibility for early phase team leaders, department staffing strategy, process optimization projects and was a member of the early phase development governance committee. Responsible for multiple due diligence teams and assessment of in license opportunities including site visits, diligence report, recommendations and create of development plans and budgets.
  • Eli Lilly And Company
    Clinical Project Manager
    Eli Lilly And Company 1997 - 2001
    Indianapolis, Indiana, Us
    Led clinical teams in the development of clinical strategies, clinical plans and timelines for early phase development assets (Discovery through Ph 2) in multiple therapeutic areas. Managed asset budgets. Led the clinical implementation teams achieving on time delivery of clinical milestones within 10% of budget. Established relationships with Academic Research Organizations and Contract Research Organizations.
  • Eli Lilly And Company
    Clinical Research Associate
    Eli Lilly And Company 1991 - 1997
    Indianapolis, Indiana, Us
    Responsible for the development of study protocols, investigator selection, study start-up training, data collection, final report writing in the areas of Neuroscience, Diabetes and Oncology. Led global submission and regulatory responses for an oncology drug
  • Indianapolis Marion County Forensic Services Agency
    Forensic Chemist
    Indianapolis Marion County Forensic Services Agency 1986 - 1989

Dawn Gardner Skills

Cro Sop Biotechnology Pharmaceutical Industry Diabetes Lifesciences Oncology Drug Development Drug Discovery Endocrinology Clinical Trials Fda Clinical Development Gmp Validation Gcp 21 Cfr Part 11 Pharmacovigilance Ind Regulatory Submissions Technology Transfer Therapeutic Areas Pharmacology Regulatory Affairs Glp Toxicology Ctms

Dawn Gardner Education Details

  • Northeastern University
    Northeastern University
    Master Of Business Administration (Mba)
  • University Of Indianapolis
    University Of Indianapolis
    Chemistry And Biology

Frequently Asked Questions about Dawn Gardner

What company does Dawn Gardner work for?

Dawn Gardner works for Immunovant

What is Dawn Gardner's role at the current company?

Dawn Gardner's current role is Vice President , Program Management.

What is Dawn Gardner's email address?

Dawn Gardner's email address is ga****@****lly.com

What is Dawn Gardner's direct phone number?

Dawn Gardner's direct phone number is .317.276*****

What schools did Dawn Gardner attend?

Dawn Gardner attended Northeastern University, University Of Indianapolis.

What skills is Dawn Gardner known for?

Dawn Gardner has skills like Cro, Sop, Biotechnology, Pharmaceutical Industry, Diabetes, Lifesciences, Oncology, Drug Development, Drug Discovery, Endocrinology, Clinical Trials, Fda.

Who are Dawn Gardner's colleagues?

Dawn Gardner's colleagues are Philip Tedeschi, Lisa Moyer, Margaret Shumel, Scott Stiffler, Lincy S. Lal, Leah Woods, Kenneth Connors.

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