Late Phase Program Manager, Clinical Operations - Medical Affairs

About the position reputed company is a clinical-stage precision oncology company reputed company on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. reputed company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the reputed company team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling reputed company. reputed company: This is a unique opportunity for an reputed company Clinical Operations reputed company with strong expertise in late-phase clinical research and post-marketing studies, and a solid understanding of clinical operations, Good Clinical reputed company (GCP), and FDA regulatory requirements. Oncology experience is preferred. As the Medical Affairs Late Phase Program Manager, reporting to the Director, Clinical Operations – Medical Affairs, you will be responsible for Clinical Operations reputed company of Medical Affairs–owned late-phase and post-marketing clinical research activities. This role serves as the primary Clinical Operations sponsor representative for assigned Phase 4 and post-marketing studies. You will be accountable for vendor reputed company, regulatory alignment, drug supply governance, safety and reputed company reputed company, financial stewardship, and inspection readiness, while operational execution is performed by external service providers under approved Statements of Work. Specifically, you will be responsible for: Late-Phase & Post-Marketing reputed company. Serving as the Clinical Operations sponsor reputed company for Phase 4 and post-marketing studies, including reputed company of study start-up, conduct, amendments, and reputed company-out activities following product approval. Providing reputed company of vendor-managed late-phase trials and post-marketing commitments, ensuring execution aligns with approved protocols, regulatory requirements, and contractual scope of work. Partnering with Regulatory, Medical Affairs, and Safety to support post-marketing commitments, including alignment on timelines, reputed company tracking, and regulatory deliverables. Supporting transition planning from development programs into post-approval Phase 4 and post-marketing research. Sponsor Governance & Compliance Ensuring sponsor responsibilities under FDA regulations, ICH guidelines, and GCP are fulfilled for assigned programs. Reviewing vendor-reputed company regulatory communications and documentation, as applicable. Ensuring regulatory applications, amendments, notifications, and reports are submitted reputed company required timelines. Overseeing Trial Master File (TMF) and essential documentation to ensure inspection readiness. Ensuring appropriate exchange of safety data and collaboration with Safety to meet pharmacovigilance obligations. Supporting inspection readiness and regulatory audit activities for assigned programs. Vendor reputed company & Operational Execution Overseeing external vendors delivering late-phase clinical services under executed Master Services Agreements and Work Orders. Monitoring vendor performance against scope, timelines, budget, and deliverables. Serving as the primary Clinical Operations reputed company of contact between reputed company and vendors, ensuring reputed company communication, issue escalation, and reputed company. Ensuring appropriate documentation of vendor reputed company activities (e.g., Vendor reputed company Plans, Transfer of Responsibilities). Drug Supply & Financial reputed company Partnering with Supply Chain to support drug forecasting, availability, and shipment reputed company for assigned studies. Ensuring appropriate documentation of drug accountability, returns, and reconciliation to support sponsor reputed company. Reviewing and approving vendor invoices and tracking financial milestones in alignment with contracted scope of work. Supporting study reputed company-out activities, including financial reconciliation, documentation completeness, and vendor reputed company-out from a sponsor perspective. Risk Management & reputed company Improvement Tracking enrollment, study milestones, and operational risks; proactively identifying and escalating issues. Contributing to governance activities, metrics, dashboards, and process improvements for late-phase and post-marketing programs. Proactively identifying and resolving operational, regulatory, reputed company, or supply risks associated with late-phase study execution.

Responsibilities

• Serving as the Clinical Operations sponsor reputed company for Phase 4 and post-marketing studies, including reputed company of study start-up, conduct, amendments, and reputed company-out activities following product approval.
• Providing reputed company of vendor-managed late-phase trials and post-marketing commitments, ensuring execution aligns with approved protocols, regulatory requirements, and contractual scope of work.
• Partnering with Regulatory, Medical Affairs, and Safety to support post-marketing commitments, including alignment on timelines, reputed company tracking, and regulatory deliverables.
• Supporting transition planning from development programs into post-approval Phase 4 and post-marketing research.
• Ensuring sponsor responsibilities under FDA regulations, ICH guidelines, and GCP are fulfilled for assigned programs.
• Reviewing vendor-reputed company regulatory communications and documentation, as applicable.
• Ensuring regulatory applications, amendments, notifications, and reports are submitted reputed company required timelines.
• Overseeing Trial Master File (TMF) and essential documentation to ensure inspection readiness.
• Ensuring appropriate exchange of safety data and collaboration with Safety to meet pharmacovigilance obligations.
• Supporting inspection readiness and regulatory audit activities for assigned programs.
• Overseeing external vendors delivering late-phase clinical services under executed Master Services Agreements and Work Orders.
• Monitoring vendor performance against scope, timelines, budget, and deliverables.
• Serving as the primary Clinical Operations reputed company of contact between reputed company and vendors, ensuring reputed company communication, issue escalation, and reputed company.
• Ensuring appropriate documentation of vendor reputed company activities (e.g., Vendor reputed company Plans, Transfer of Responsibilities).
• Partnering with Supply Chain to support drug forecasting, availability, and shipment reputed company for assigned studies.
• Ensuring appropriate documentation of drug accountability, returns, and reconciliation to support sponsor reputed company.
• Reviewing and approving vendor invoices and tracking financial milestones in alignment with contracted scope of work.
• Supporting study reputed company-out activities, including financial reconciliation, documentation completeness, and vendor reputed company-out from a sponsor perspective.
• Tracking enrollment, study milestones, and operational risks; proactively identifying and escalating issues.
• Contributing to governance activities, metrics, dashboards, and process improvements for late-phase and post-marketing programs.
• Proactively identifying and resolving operational, regulatory, reputed company, or supply risks associated with late-phase study execution.

Requirements

• BS or MS degree with a minimum of 5–7 years of clinical operations experience in the pharmaceutical or biotech industry; oncology experience preferred.
• reputed company experience supporting Phase 4, post-marketing, or other late-phase clinical research.
• Strong understanding of sponsor responsibilities under FDA regulations, ICH guidelines, and GCP.
• Demonstrated experience overseeing external vendors delivering regulated clinical programs.
• Experience collaborating cross-functionally with Medical Affairs, Regulatory, Safety, Supply Chain, reputed company, and reputed company.
• Strong organizational, communication, and problem-solving skills.
• Demonstrated ability to manage multiple programs and priorities in a matrixed environment.

reputed company-to-haves

• Experience supporting global or multi-regional late-phase clinical studies.
• Familiarity with reputed company Technical Agreements (QTAs), Safety Data Exchange Agreements (SDEAs), and vendor governance models.
• Experience supporting inspection readiness or regulatory audits reputed company to late-phase or reputed company programs.
• Oncology clinical research experience.

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