Senior Regulatory Affairs Director: Nonclinical Product Development (R1024521) in Durham, NC bei IQVIA™

Datum der Veröffentlichung 10/17/2019

Stellenauszug

  • Mitarbeiterkategorie:
    Vollzeitbeschäftigung
  • Standort:
    Durham, NC
  • Berufserfahrung:
    Not Specified
  • Datum der Veröffentlichung
    10/17/2019
  • Job ID:
    R1024521

Stellenbeschreibung

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

PURPOSE

Our clients are constant innovators with global reach and a drive to bring new healthcare products to market. We’re proud to support them in their journey.

This role is a key part of the process, partnering with our clients to ensure they are ready for first in human trails wherever they may be.

Using broad management discretion, you will have direct responsibility for the design and elucidation of complex product development strategies for drugs, biologics, and biotechnology products focusing on nonclinical product development ensuring quality deliverables are on time, within budget and that all work is completed in accordance with SOPs, policies and practices.  In addition, you will contribute to development of gap analyses, indication prioritizations, target product profiles, clinical development plans, clinical study designs and other work products in your area of expertise.

RESPONSIBILITIES

  • Hands-on review and/or creation of nonclinical product development strategies to meet regulatory requirements for first-in-human and/or registrational clinical studies
  • Strategic regulatory guidance, including integrating non-clinical information to appropriately time and design clinical studies to address safety related issues, in particular safety & efficacy interactions.
  • Provide interpretive guidance for strategic decision making critical for safety, marketability and regulatory requirements
  • Utilize extensive expertise in toxicology & DMPK to evaluate toxicokinetic responses identified in nonclinical product development and guide subsequent evaluation in clinical studies for safety related issues (e.g. liver enzyme elevations, transport interactions, etc).  
  • Review product development strategies (both nonclinical and clinical) to assess  compliance with EPA, FDA GLP regulations, EMEA
  • May act as a global contact and/or lead for a specific customer
  • May take a proactive role in developing long standing relationships with preferred IQVIA customers, and may take a leadership role in bid defence strategy and planning, as appropriate
  • Continually looks for process improvements
  • Competently manages meetings/expectations with Regulatory Agencies and/or groups within IQVIA
  • May lead major, global cross-functional initiatives, accountable for success
  • May represent IQVIA by leading a cross-industry workgroup in an area of expertise

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Held positions of increasing responsibility in the pharmaceutical, biotechnology and/or CRO sectors
  • Extensive experience in development of regulatory strategy and development plans
  • Strong experience in regulatory agency interaction
  • Small molecule, Peptide, Biological and stem cell experience
  • Extensive expertise in toxicology & DMPK
  • Expertise in Good Laboratory practices, worldwide regulations, safety assessment SOP’s, protocols, policies and procedures
  • Extensive experience in regulatory and/or technical writing and/or process management
  • Ability to make difficult judgment calls within sphere of responsibility. Demonstrates advanced negotiating, influencing and motivating skills, with the ability to identify and resolve issues at a senior level within IQVIA and customer organizations
  • Strong software and computer skills, including MS Office applications
  • Acts as a role model for professionalism and a respected ambassador for the Regulatory Business Unit, remaining effective in difficult, stressful and/or highly sensitive situations
  • Ability to accept senior management decisions and deliver positive messages to peers
  • Ability to communicate effectively at all levels in the organization, consistently demonstrating confidence and authority within remit
  • Ability to monitor the market and demonstrate knowledge of competitors and clients

MINIMUM REQUIRED EDUCATION

Advance degree in life science-related discipline or professional equivalent* plus extensive regulatory experience (*or combination of education, training and experience)

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.



Job ID: R1024521