Therapeutic Strategy VP, EU/EMA Regulatory Strategist (Home - Based)

Overview

IQVIA is seeking an experienced and passionate pharmaceutical product development strategist to join our team as Therapeutic Strategy VP. The ideal candidate will have a deep understanding of the pharmaceutical industry, a proven track record of driving innovation and commercial success, and a strong desire to make a significant impact in the field. A strong background in current EU/EMA regulatory expectations and the global landscape across multiple therapeutic areas is preferred.

Essential Functions

• As the Therapeutic Strategy VP, you will be responsible for creating integrative product development strategies for pharmaceutical products, including drugs, biologics, and devices. This role will focus on clinical-commercial convergence and will encompass all phases of development from discovery to market. You will oversee preclinical strategy, clinical strategy, regulatory strategy, and commercial strategy, and assess the risk and probability of success for candidate pharmaceutical products, including preparation of a gap analysis with a focus on clinical development.
• Lead and support clinical trial design and all associated aspects for various clients.
• Provide strategic and therapeutic area guidance for clinical development plans in compliance with applicable regulatory, medical, and ethics guidelines.
• Ensure high-quality, data-driven deliverables that meet the highest standards of medical, ethical, and scientific integrity and conduct.
• Propose strategies to manage and accelerate timelines for drug development strategies.
• Identify, promote, and develop innovation in pharmaceutical product development.
• Provide drug development expertise to support strategic business activities and investment opportunities.
• Assist in the development of programs to maximize the organization's growth and profitability.
• Ensure customer satisfaction by working closely with senior management, CRO operations, therapeutic units, and other operations heads to provide optimum strategic consultancy to customers.
• Serve as a key resource and participate in strategic business development activities, including presentations to prospective clients, professional meetings, or other business development activities for IQVIA Strategic Drug Development.
• Provide internal and external therapeutic and pharmaceutical development-related educational services in support of all branches of IQVIA business.
• Attend key scientific meetings/conferences and keep abreast of relevant scientific publications to maintain awareness of current scientific developments and progress in drug development methodology. As appropriate, representing IQVIA or the partner in such meetings.
• Develop and maintain ongoing relationships with pharmaceutical and biotechnology companies, key opinion leaders, and identify new business opportunities.
• Provide due diligence scientific, medical, regulatory, and drug development expertise and activities for IQVIA or IQVIA customers.
• Preference will be given to candidates with recent previous health authority experience (current or EU/EMA medical reviewers, etc.)

Qualifications

• MD Degree required.
• 15+ years of relevant clinical research experience with a multi-regional and global focus, including 10 years of leadership experience.
• Excellent communication and presenting skills.
• Business Development Experience
• Extensive use of telephone and face-to-face communication requiring accurate perception of speech
• Extensive use of keyboard requiring repetitive motion of finger
• Regular sitting for extended periods of time

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. Learn more at

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

Therapeutic Strategy VP EUEMA Regulatory Strategist Home Based • Frankfurt, Hesse, Germany