Jobs at Nuvation Bio

Lead and manage clinical trial operations including CRO and vendor oversight, study planning, budgets, site selection, regulatory compliance (GCP/ICH), document development, inspection readiness, and cross-functional coordination for oncology trials across phases.

Lead analytical development and QC activities from early development through commercial support, including method development/validation/transfer, stability and release testing, vendor/CRO/CMO management, regulatory submission authorship, audits/inspections, and MAH oversight for China market with routine on-site supervision.

Lead commercial sales for an assigned oncology territory, build relationships with HCPs and KOLs, generate demand, execute account plans, leverage data and omnichannel tools, support product launches, represent company at conferences, and comply with regulatory and credentialing requirements.

Lead quality assurance for CMC activities with CDMO/CMO partners: supervise tech transfer, process validation, review specifications, protocols, release data, deviations, CAPA, and audits; maintain MAH quality system, archive technical documents, update SOPs, and ensure commercial product quality compliance.

Lead external clinical and health economic value discussions with payers and access stakeholders. Translate clinical, RWE, and HEOR findings into payer-focused value narratives, develop compliant value materials (AMCP dossiers, payer decks, economic frameworks), and align evidence plans with Market Access and Medical Affairs across pre-approval, launch, and lifecycle stages. Capture payer insights, identify evidence gaps, and support RWE prioritization while ensuring medical accuracy and regulatory compliance.

Lead medical strategy and provide medical oversight for global/regional oncology clinical trials. Support clinical development planning, protocol and safety document authoring, data interpretation, regulatory interactions, medical monitoring, cross-functional collaboration, and ensure GCP and regulatory compliance to meet program milestones and timelines.

Field-based Oncology Account Manager responsible for commercial sales in an assigned territory: building KOL relationships, driving demand and launch goals for NSCLC therapies, developing account plans with cross-functional partners, leveraging omnichannel and data, attending conferences, and meeting compliance, credentialing, and travel requirements.