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Associate Director, Strategic Feasibility (Office-Based) - IQVIA Biotech (R1078330) in Morrisville, NC at IQVIA™

Date Posted: 6/7/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Date Posted:
    6/7/2019
  • Job ID:
    R1078330

Job Description

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

BASIC FUNCTIONS:

The Associate Director (AD) North America (NA) is responsible for directing all the efforts necessary for producing feasibility proposals and reports for business development activities.  In this capacity this individual is responsible for setting priorities for workload and deliverables and assuring the Feasibility  Department elicits input from and coordinates activities with all of the stake holders in the feasibility process including: Proposals, Investigator Strategy and Site Coordination, Regulatory, Medical Affairs, Project Management and Clinical Operations and combining resulting information with IQVIA Biotech’s corporate experience to produce recommendations for country and site selection strategies.  In this capacity, the AD NA Feasibility assures the integrity of the data sources used as well as the proper interpretation and resulting strategy provided in feasibility proposals and reports, (feasibility proposals are documents that detail the strategy, actions, and the cost of conducting feasibility, while feasibility reports are documents that describe the outcomes of feasibility projects).  This individual participates in internal meetings and may be called on to represent IQVIA Biotech at bid defense opportunities not only in NA but also globally. The AD NA Feasibility assures the evaluation, assembly, editing, and review of feasibility proposals and reports.  The AD NA Feasibility plays a major role in defining long term goals and direction of the Department globally.   This position reports directly to the VP of Operations.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

  • Directs the activities of the Feasibility Department and provides oversight for the activities of the Feasibility Analysts and their supporting Managers within the Department which includes:
    • Identifying and present regions where the disease is prominent to create an initial country pool to be further refined based on corporate experience, operational capabilities, medical input, and other feasibility considerations
    • Identifying barriers to enrollment in the form of competing clinical trials.  Accessing open source and proprietary databases to determine similar patient populations and or therapeutic classes of drugs being studied.  Determine whether the countries proposed have comparator drug access/reimbursement. As appropriate prepare tabular displays of this information for evaluation by the feasibility stake holder pool.
    • Representing IQVIA Biotech’s global or regional expertise by presenting our clinical trial footprint in the indication which may include compiling corporate experience and expertise in specific indication when needed.
    • Working with IQVIA Biotech medical experts on the conduct of the trial as well as its acceptance and standard of care in target regions.  Incorporate medical review of the protocol and challenges to enrollment and the retention of subjects. 
    • Collaborating with IQVIA Biotech Regulatory Affairs determine timelines associated with the conduct of the proposed trial.
    • Work with the Investigator Strategy and Site Coordination (ISSC) group to determine costing of conducting a questionnaire process with potential sites if appropriate.
    • Provides overall recommendations on the countries, number of sites and projected number of patients resulting from collaborative discussions noted above designed to meet or exceed client stated goals.  
    • This function also identifies alternative to client initial recommendations resulting from information gathered.
  • Develops increased capacity within the Feasibility Department to assure ability to meet overall Corporate Business Development Goals.
  • Develops project timelines for department of internal staff.
  • Provides guidance as needed for completion of tasks.  Assesses performance and recommends salary adjustments for Analysts as the department expands to include other team members.
  • Designs, develops, and updates to Standard Operating Procedures for all Feasibility functions.
  • Assures that Feasibility function interfaces effectively with all other key operating departments within IQVIA Biotech.
  • Develops budgets and maintain metrics on the feasibility department’s workload and productivity and is accountable for maintaining department activities within approved financial guidelines.  
  • Works with Human Resources in recruiting and hiring qualified Feasibility Analysts staff for effective Department functions.
  • Defines training for the Feasibility staff. 
  • Reviews and approves reports and manuscripts, as necessary.
  • Maintains current knowledge of regulations, and guidelines appropriate for functioning in this capacity.
  • Serves in a consulting capacity to the operations teams including the Operational side of ISSC.
  • Participates in business development activities as requested to grow IQVIA Biotech business.

KNOWLEDGE, SKILLS AND ABILITIES:

  • Knowledge of government/international databases, open source databases or more proprietary databases (e.g., PubMed/Medline, ClinicalTrials.gov, BioPharm Clinical, Citeline).
  • Demonstrate ability to form strong working relationships with other groups within the organization essential to high level performance in this position.
  • Demonstrate knowledge of quality assurance related to the Feasibility process and willingness to promote the quality process within the group.
  • Ability to motivate, lead, and grow a team.
  • Experience with pharmaceutical product development.
  • Knowledge of FDA and/or ICH guidelines for conducting clinical research.
  • Excellent written and verbal communication skills.
  • Exceptional ability to conceptualize, develop and manage timelines.
  • Demonstrated knowledge of resources required to permit development of or reporting on results of the feasibility process.
  • Considerable ability to develop and maintain productive relationships with colleagues and other research organizations.
  • Ability and willingness to travel nationally or internationally as requested.

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

  • Ability to travel domestically and internationally
  • Very limited physical effort required to perform normal job duties

MINIMUM RECRUITMENT STANDARDS:

  • BS in a health-related field with at least five years of demonstrated clinical research experience; or appropriate BA/BS Degree in life sciences (i.e., nursing, pharmacy, pre-medicine, etc.) or appropriate degree post-doctoral studies.  Within the total years of experience, at least one (1) year must be in a contract clinical research organization. 
  • Pharmaceutical clinical research experience and demonstrated extensive electronic research and manuscript preparation is required. 
  • Demonstrated expertise in the research and preparation of feasibility proposals.
  • Excellent written and verbal communication skills, with superior ability to present data in a clear and concise format through preparation of tables and graphic representations that lead to the ability to understand the data being presented, is a requirement.

CLASSIFICATION:

This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™

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: R1078330