Associate Director, Strategic Feasibility, Home-Based USA - IQVIA Biotech

***IQVIA Biotech has an excellent opportunity for an experienced pre-award Associate Director, Strategic Feasibility.This individual will help develop unique strategies to create a competitive edge and actively contribute to winning new business for IQVIA Biotech.This is a fulltime regular position with competitive benefits package, and is fully remote-based.If you have a passion for helping smaller biotech companies move forward in their effort to get treatments to patients, then apply to IQVIA Biotech today for immediate consideration! ***

BASIC FUNCTIONS:

The Associate Director (AD) 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 stakeholders in the feasibility process including: Proposals, Therapeutic 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 Strategic 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 client meetings.  The AD Strategic Feasibility assures the evaluation, assembly, editing, and review of feasibility proposals and reports. The AD Strategic Feasibility plays a major role in defining long term goals and direction of the Department globally.   The AD Strategic Feasibility may have primary line management responsibility of staff, including oversight of hiring, training, appraising performance, professional development, and discipline.  This position reports directly to the department head.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

• 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.
• 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 presenting 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 to determine regulatory timelines and requirements associated with the conduct of the proposed trial.
  • Work with the Integrated Site Services (ISS) 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 alternatives to client initial recommendations resulting from information gathered.
• As needed, manages staff responsible for providing Strategic Feasibility services.
  • Oversees hiring and training of Feasibility staff, develops training requirements, and directs onboarding of new employees.  Includes working with Human Resources in recruiting and hiring qualified Feasibility staff for effective Department functions.
  • Defines the training for the Feasibility staff.
  • Manages staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance, mentoring and guiding professional development; addressing employee relations issues and resolving problems.
• Promotes and utilizes the IQVIA CORE™ data sets and resources to define and enhance the enrollment strategy.
• 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 ISS.
• Participates in business development activities as requested to grow IQVIA Biotech business.

KNOWLEDGE, SKILLS AND ABILITIES:

• Demonstrated knowledge and proficiency of the IQVIA CORE™ data sets, services and resources.
• 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-GCP guidelines for conducting clinical research.
• Excellent written and verbal communication skills.
• Exceptional ability to conceptualize, develop and manage timelines.
• Strong proficiency of Microsoft Office applications and data queries.
• 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.

CRITICALJOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

• Very limited physical effort required to perform normal job duties.
• Ability to travel, as needed (domestically or internationally).

MINIMUM RECRUITMENT STANDARDS:

• BS in a life sciences-related field with at least ten years of demonstrated clinical research experience; or an advanced degree (MS or PhD) with 5 years of demonstrated clinical research experience.  Within the total years of experience, at least 4 years must be in a contract clinical research organization.
• Has at least 5 years as a feasibility analyst and/or manager in a pre-award setting (not applicable to functional line manager candidates).
• Demonstrated consistency of exceeding goals and/or performance expectations as a Feasibility Manager (internal department candidates only).
• Pharmaceutical clinical research experience or demonstrated extensive electronic research and manuscript preparation is required.
• Demonstrated expertise in the research and preparation of feasibility proposals strongly preferred.
• Demonstrated career progression or advancement.
• 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.
• Previous line management experience, preferred.

CLASSIFICATION:

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

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

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.