Senior Manager, Medical Information and Medical Capabilities

Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Our vision is to significantly change the practice of oncology by developing medicines that provide truly meaningful improvements in quality of life and survival for people with cancer.

The Senior Manager, Medical Information and Medical Capabilities, will report to the Director, Medical Capabilities and will be a critical member of the Medical Affairs team. This individual will provide integral Medical Information & Medical Capabilities support across Nuvation Bio’s pipeline which includes serving as the medical reviewer on the MLR committee, leading the development of Medical Information deliverables, and overseeing the Independent Medical Education (IME) grant review process.

Medical Information

• Serve as an active member of the Medical Affairs team, providing relevant Medical Information insights and metrics to inform the overall strategy as well as ensuring Medical Information activities are aligned with medical plans as appropriate
• Lead the development, review, maintenance, and approval of Medical Information materials, including Standard Response Letters (SRLs), Frequently Asked Questions (FAQs), and custom responses
• Manage Medical Information operations, vendor oversight, budget, and compliance activities to ensure the delivery of timely, accurate, scientifically balanced, and regulatory-compliant medical information
• Ensure the call center is fully trained on content availability and escalation processes
• Ensure all MI content is scientifically rigorous, balanced and aligned with the quickly evolving data
• Partner with Medical Information vendors and cross-functional stakeholders, including Pharmacovigilance, Clinical, and Medical Strategy, to support medical inquiry responses and compliance adherence and regulatory readiness.
• Alongside Director Medical Capabilities, manage Medical Information metrics, quality indicators, and inquiry trends, and contribute to process improvements, SOP development, training initiatives, and operational excellence activities.

Medical Review and Governance

• Serve as the Medical reviewer within the Medical, Legal, and Regulatory (MLR) review processes, providing scientific leadership and medical oversight for promotional and non-promotional materials.
• Lead medical accuracy review and provide strategic scientific input to ensure materials are accurate, balanced, evidence-based, and aligned with approved data, medical strategy, and applicable regulations.
• Collaborate with cross-functional stakeholders to facilitate timely review and approval of materials while maintaining scientific integrity and alignment with approved data and medical strategy.
• Support the development and continuous improvement of MLR review processes, guidance documents, and best practices to enhance consistency, compliance, and operational effectiveness.
• Serve as MLR Coordinator for medical affairs content, ensuring pieces are reviewed and approved in a timely manner to meet business needs.

Medical Affairs Capabilities

• Serve as business owner for Medical Affairs website, overseeing content, review coordination, maintenance, and ongoing optimization to ensure accurate, compliant, and user-focused medical content.
• Manage operations of IME grant reviews and approvals, including running monthly Grant Review Committee meetings.
• Support other medical capabilities projects as needed, as aligned with Director Medical Capabilities, team needs, and to support individual professional development.

• Advanced degree (MD, PhD, PharmD) in a medical or…