Senior Director, Observational Research

This is a fully remote position, open to applicants in United States, +1 more country.

📋 Description

• Oversee the clinical operational strategy and implementation across the Observational Research portfolio.

• Convert evidence generation strategies into operationally achievable delivery frameworks.

• Direct the operational planning, execution, governance, and performance of the portfolio.

• Offer operational insights into Evidence Generation Plans, Key Design Elements, protocols, feasibility assessments, and study documentation.

• Create operational plans, timelines, resource forecasts, and budget strategies.

• Lead the identification of portfolio risks, planning for mitigation, and resolution of operational issues.

• Develop standardized clinical operational methodologies to ensure consistency, quality, and effective execution.

• Manage vendor strategy, outsourcing models, governance, and performance oversight for Real-World Evidence Clinical Operations.

• Represent Real-World Evidence Clinical Operations in Product Teams, governance forums, and operational reviews.

• Collaborate with the Center for Observational Research and Regional and Country Operations.

• Oversee inspection readiness, audit preparedness, and corrective and preventive actions.

• Supervise portfolio performance monitoring, enrollment strategies, recruitment forecasting, and delivery metrics.

• Lead organizational design, workforce planning, and succession strategies.

• Enhance organizational capabilities through leadership development, coaching, performance management, and competency enhancement.

• Allocate functional resources while establishing priorities, operating principles, and standardized practices.

• Promote operational excellence, innovation, continuous improvement, and the adoption of scalable delivery models.

• Assess emerging operational approaches, technologies, and digital capabilities.

• Cultivate an inclusive, collaborative, high-performing culture while advancing Observational Research capabilities.

⛳️ Requirements

• A Doctorate degree with 5 years of experience in clinical research, clinical operations, and/or real-world evidence OR a Master's degree with 9 years of experience OR a Bachelor's degree with 11 years of experience.

• At least 5 years of direct people management and/or leadership experience overseeing global teams, programs, portfolios, or organizational functions.

• Over 10 years of experience in the biopharmaceutical industry, with considerable experience in global clinical development and evidence generation.

• Proven leadership in global clinical operations across complex development programs and/or evidence generation portfolios.

• Experience in leading observational research, pragmatic clinical trials, and other real-world evidence generation methodologies within a pharmaceutical or biotechnology setting.

• Background in developing and implementing clinical operational strategies across global, cross-functional organizations.

• Experience managing global, matrixed organizations with a focus on organizational capability, workforce planning, and talent development.

• Oversight experience with external service providers, including CROs, strategic functional service providers, technology partners, and other outsourced operational models.

• Proven experience in leading organizational change, operational transformation, and continuous improvement initiatives.

• Demonstrated success in representing clinical operations in senior governance, portfolio, and cross-functional leadership forums.

🏝️ Benefits

• A comprehensive employee benefits package, featuring a Retirement and Savings Plan with generous company contributions.

• Group medical, dental, and vision coverage.

• Life and disability insurance.

• Flexible spending accounts.

• A discretionary annual bonus program.

• Stock-based long-term incentives.

• Award-winning time-off plans.

• Flexible work models where feasible.

• Opportunities for career development.

• Financial plans that allow saving towards retirement or other personal goals.

• Support for work/life balance.