Head of Regulatory Strategy, Patient Centered Solutions

Overview

IQVIA provides scientific services spanning clinical trials, real world evidence, and consulting in all areas of the medical product lifecycle. The Patient Centered Solutions (PCS) team leads the industry in generating data to ensure that the patient voice is incorporated into the development and commercialization of medication and other drug/non-drug interventions. We focus on understanding and meeting the needs of our customers (mostly life science/pharmaceutical companies) through the application of broad consulting expertise and technical scientific knowledge to design scientifically rigorous research to capture insights about patient priorities, needs, preferences and experiences. This research is broad and includes qualitative (e.g., interviews, focus groups), quantitative (e.g., clinical outcome assessments [COAs]/patient-reported outcomes [PROs], preference research) and passive (e.g., digital health technology tools) approaches to understand patient, caregiver and healthcare professional experiences and expectations of disease and treatment.

Individuals joining us are assured of a rewarding and progressive career in life sciences consulting. They have the opportunity to address challenging client issues, across multiple geographies with a hands-on influence in delivering solutions.  We operate in a truly multi-cultural, collegial, and collaborative work environment that is rich in development and growth.

Role & Responsibilities

The Head of the Center of Excellence (CoE) for Regulatory sits within the consulting business of PCS and plays a key role in its global leadership team. This individual is a true expert in both the guidance and the practice of developing strategies and evidence to engage US FDA, the EMA and other regulatory agencies on COA endpoints and the use of PED in a regulatory context. This individual fulfills three key functions: 1) bringing their expertise to bear in proposals, to project delivery, and to customers in support of business growth and impact; 2) developing the regulatory capabilities of the PCS consulting organization through training, process improvement and mentorship; and 3) maintaining an active external profile and involvement in the regulatory landscape for PED.

Key responsibilities are:

Customer-facing activities

• Develop and deliver insightful, value-added regulatory strategies that address complex client issues relating to COA endpoints and PED
• Support sales efforts by providing regulatory subject matter expertise to customer meetings and proposals
• Support delivery teams who are executing PCS projects with a regulatory component, and ensure we provide consistently high quality insights and content
• Support billable projects as SME and/or study lead, per study requirements, at 40% utilization or greater

Capability building

• Support community building with activities including recruitment, coaching, management of resources and network development (both juniors and seniors) to collaborate with for regulatory delivery and/or business development purposes
• Directly line manage a small global team of regulatory specialists
• Mentor, coach, and share subject matter expertise with others to help develop individuals and capabilities delivering world-class solutions for clients
• Provide training, templates, and oversight to upskill team and ensure consistent high quality consulting and written deliverables
• Participate in annual performance review team processes
• Engage in recruitment and selection of new staff

External profile

• Develop and oversee the PCS thought leadership agenda for the regulatory capability. Represent IQVIA in external working groups and consortia
• Lead development of IQVIA’s responses to public consultation processes from FDA and other regulatory agencies relating to PED
• Contribute to the enhanced awareness of PCS in the marketplace, e.g., through speaking engagements, client meetings, and publications
• Develop and facilitate understanding of emerging regulatory practices, expectations and engagements outside of the US FDA and EMA

In addition, take on other leadership responsibilities as needed, including:

• Member of global PCS consulting leadership team and scientific leadership team
• Provide regulatory subject matter expertise to the broader PCS organisation (e.g. to instrument ownership and licensing business, and to the implementation services business)

About You

Candidates interested this position will have:

• Advanced degrees and 10+ years of experience in patient experience data research, incl