Head of COA Regulatory Strategy, Patient Centered Solutions

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 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 Strategy sits within the COA 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 to engage US FDA, the EMA and other regulatory agencies on COA endpoints and the use of Patient Experience Data (PED) in a regulatory context. This individual fulfills three key functions:

• Bringing their own expertise to bear in proposals, to project delivery, and to customers in support of business growth and impact;
• Developing the regulatory capabilities of the PCS consulting organization through training, process improvement and mentorship;
• 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 related to PED to the broader PCS organisation (e.g. to instrument ownership and licensing business, and to the implementation services business).

About You

Candidates interested in this position will have:

• Advanced degrees and 15+ years of experience in PED research, including COA science, preference research, and regulatory engagement (US FDA essential, EMA and other regulatory agencies desirable);
• Experience working in a regulatory agency and/or demonstrable track record of developing and executing a COA endpoint strategy with successful outcome of COA label claim;
• Experience preparing for, and participating in Type B and Type C meetings with FDA;
• Experience in developing patient experience materials for regulatory consultations and submissions (e.g. COA dossier, briefing documents for Type B/C/D consultations);
• An understanding of the global regulatory environment as it pertains to PED;
• Strong scientific consulting skills and track record of contributing to business development in a consulting environment;
• Experience of medical writing for various audiences, including pharmaceutical companies, healthcare professionals, regulatory bodies and patients;
• Publications and recognition in the field through participation in industry consortia or scientific bodies. Experienced public speaker;
• Well-developed written and verbal communication skills including presentations, business and report writing;
• An entrepreneurial nature and interest in developing new client offerings and solutions;
• Demonstrable analytical, interpretative, and problem-solving skills;
• Excellent interpersonal skills and ability to work effectively with others;
• An ability to work in a fast-paced environment with demonstrated ability to effectively manage multiple tasks;
• An ability to establish and maintain effective working relationships in multi-disciplinary and international teams;
• Fluency in English (spoken and written);
• Willingness and ability to travel from time to time;
• Right to live and work in the recruiting country.

Physical requirements:

• Extensive use of telephone communication requiring accurate perception of speech;
• Extensive use of keyboard requiring repetitive motion of fingers;
• Regular sitting for extended periods of time;
• Travel as required.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.