Senior Principal, Prospective Observational Studies, RWE

Senior Principal, Prospective Observational Studies, RWE

CoE: Low Complexity Non-Interventional Studies (LCNIS), MedSci

Location: Candidates must be based in the US

The Role

The Senior Principal will assume a leadership position within the Medical and Scientific Services team, tasked with establishing a Center of Excellence (COE) specializing in low-complexity observational studies (LCNIS) across the United States (US). This role entails direct engagement with clients to sell, design, and execute innovative real-world evidence (RWE) observational studies, crucial for informing payer and regulatory decisions. The Senior Principal will take full responsibility for shaping strategy, driving growth, and ensuring the financial success of the US LCNIS business.

Essential Functions

• Accountable and responsible for the creation and development of the US LCNIS Center of Excellence (COE) within the US Real World Solutions (RWS) business including but not limited to:
  • Define the delivery model for US LCNIS in collaboration with regional and global leadership teams.
  • Lead strategic initiatives aimed at advancing US LCNIS objectives.
  • Develop and implement standard operating procedures (SOPs) and working instructions to support COE operations.
  • Employ processes necessary to enforce study teams' adherence to SOPs and work instructions for consistent compliance during study execution. 
• Accountable for achieving all revenue targets and associated operational metrics.
• Provide scientific and operational advice to internal stakeholders developing proposals: including providing the strategy to protocol design/project development plan, reviewing the protocol for scientific/regulatory soundness and feasibility, identification of target sites or investigator profiles, anticipated patient recruitment, standard of care and competitive landscape.
• Lead strategic initiatives aimed at advancing US LCNIS objectives.
• Directly manage the sale and delivery of US LCNIS studies, ensuring high-quality outputs that meet regulatory standards and exceed client expectations.
• Lead the development of proposals and provide innovative study design recommendations aligned with client needs.
• Serve as the US Subject Matter Expert (SME) supporting the growth of Global Business Units (GBU) in LCNIS.
• Develop and implement standard operating procedures (SOPs) and working instructions to support COE operations.
• Ensure study teams adhere to SOPs and working instructions to maintain compliance throughout study conduct.
• Participates in strategic business development activities including presentations to prospective clients and professional meetings.
• Maintains awareness of industry pipeline and FDA regulations and guidance, scientific and business developments in the US RWE markets to position IQIA with differentiated offerings and solutions.
• Coach, mentor, and develop team members to foster a high-performance culture.

Professional Skills

• Excellent communication, presentation and interpersonal skills (both written and spoken)
• Strong leadership skills, ability to work with minimal supervision, and lead a virtual team in a matrix organization.
• Innovative and strategic thinker.
• Strong business acumen including confidence with financial considerations, excellent negotiation and influencing skills, and comfort working in both sales and operational environments.
• Flexible and able to work in situations where specifications may or may not be well defined.
• Confident and capable in the use of technology, applications and other media e.g., databases and internet to research assess new opportunities, maintain currency of therapeutic and operational knowledge and competitive landscape.
• Proven ability to make decisions with limited information, bringing clarity to disparate information to inform actions and drive results.

Interpersonal Skills

• Ability to establish and maintain effective working relationships with coworkers, managers and clients. Maintains a positive outlook at work; handles criticism well and learns from it.
• Ability to establish and maintain effective working relationships with a wide network of individuals e.g., coworkers, managers and customers.
• Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues.

Qualifications

• Bachelor's degree required/master’s degree preferred.
• Minimum 15 years in the pharmaceutical industry, with at least 8 years