Associate Director, Medical Capabilities, NRDG Operations

Role Summary

Associate Director, Medical Capabilities, NRDG Operations will build and lead the Non-Registrational Data Generation (NRDG) program at Nuvation Bio, establishing governance, SOPs, and end-to-end processes for ISR, CRS, and other external data generation initiatives. The role ensures operational and financial oversight of clinically initiated external research, and aligns NRDG activities with Medical Affairs priorities while maintaining compliance and scalable operations. The candidate will be a hands-on leader who builds programs from the ground up and serves as a central cross-functional partner with Medical Affairs, Legal, Compliance, Clinical Development, and Finance.

Responsibilities

• Establish, build, and manage a comprehensive Non-Registrational Data Generation (NRDG) program, including the creation and implementation of all associated Standard Operating Procedures (SOPs).
• Establish, lead, and manage a review committee or equivalent governance body responsible for the review and approval of all ISR, CRS, and other external research proposals.
• Serve as the primary author and owner for all SOPs related to NRDG operations, ensuring continuous improvement and regulatory compliance.
• Design and implement streamlined end-to-end operational processes for the intake, review, tracking, and completion of all external research.
• Lead the identification, selection, and implementation of an enterprise-level operations system to manage all NRDG activities, ensuring it is fit-for-purpose and globally scalable.
• Create, implement, and manage a robust NRDG budget forecasting model to increase forecasting accuracy and oversee all NRDG budget planning and tracking.
• Manage all external vendors supporting NRDG activities, including budgeting, contracting, and performance management.
• Serve as the primary Medical Affairs cross-functional partner for NRDG, liaising extensively with Medical Affairs Strategy, Field Medical, Legal, Compliance, Clinical Drug Supply, Clinical Development, and Finance.
• Act as the internal Subject Matter Expert (SME) on Fair Market Value (FMV) as it relates to external research activities.
• Responsible for Alliance Management inclusive of meeting coordination and alignment of agendas.

Qualifications

• Bachelor’s degree in life science, pharmacy, or medical-related field with 7+ years of experience in the pharmaceutical or biotech industry, specifically in Medical Affairs operations.
• Experience establishing and leading a Review Committee or equivalent governance body for ISR and/or Collaborative Research programs.
• Direct, hands-on experience building new Medical Affairs programs from inception, including the creation, review, and implementation of all associated SOPs.
• Demonstrated success in identifying, selecting, and implementing an enterprise-level operations system (e.g., for ISR management) for company-wide use.
• Expertise in creating and building budget forecasting models for external research, leading to increased budget accuracy.
• Experience as a functional operations lead for external research programs.
• Deep knowledge of the compliance and regulatory landscape for NRDG, ISR, and other external research activities.
• Exceptional project management, communication, and leadership skills.

Education

• Bachelor’s degree in life science, pharmacy, or medical-related field

Skills

• Problem-Solver - As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
• Personable - You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
• Credible - Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
• Emotional intelligence, curiosity, and a knack to figure out a way to build something better
• Communication - Effectively listens, conveys, and receives ideas. Maintains a consistent flow of information. A strong presenter and effective communicator with the ability to influence stakeholders.
• Accountability - Acts with a clear sense of ownership - whether the task is in their role description. Holds yourself and others accountable to execute all tasks at hand through seen and unforeseen circumstances with high quality and integrity.
• Adaptability - Can manage in an environment of ambiguity. Embraces the change of a new system, process, technology, or idea in the organization. You could reassess priorities, alter goals and take risks.