Jobs at Summit Therapeutics, Inc.

Leads strategic market access and account engagement for oncology therapies across IDNs, academic centers, health systems, and community oncology networks. Develops account plans, drives clinical pathway and protocol inclusion, builds executive and formulary relationships, negotiates agreements, identifies reimbursement barriers, coordinates cross-functional teams, supports product launches, and provides market intelligence to commercial leadership. The role requires extensive oncology market access experience and up to 50% travel.

Leads pharmacovigilance and medical safety activities for investigational and marketed oncology products. Responsibilities include reviewing individual case safety reports, evaluating adverse events and signals, supporting expedited reporting and unblinding, preparing aggregate safety documents, maintaining reference safety information, coordinating with safety committees and vendors, ensuring regulatory inspection readiness, improving medical safety processes, and mentoring medical safety reviewers.

Leads clinical quality assurance activities across clinical and preclinical programs. Responsibilities include managing clinical site and vendor audits, overseeing quality plans, CAPAs, investigations, inspection readiness, regulatory compliance, vendor issues, and internal audits. The role advises cross-functional teams on GCP, GLP, pharmacovigilance, and global health authority requirements while supporting continuous process improvement and quality risk management.

Leads global regulatory affairs activities for oncology clinical studies and ivonescimab development. Responsibilities include regulatory strategy, CTA and IND submissions, BLA/MAA filing support, FDA and health authority interactions, submission tracking, regulatory dossier management, labeling oversight, query responses, and cross-functional guidance. The role requires pharmaceutical regulatory experience, knowledge of US and international requirements, and expertise working with clinical studies, CROs, and regulatory agencies.

Leads global compensation and benefits programs, including salary structures, incentive plans, equity, benefits, open enrollment, 401(k), leave administration, compliance, audits, and payroll coordination. Owns HR metrics, systems, policies, process improvements, change management, and AI-in-HR strategy. Partners with leadership, vendors, payroll, IT, and external stakeholders to improve employee experience and operational efficiency.

The Director, Value Outcomes Liaison engages payers, health systems, P&T committees, pathway organizations, and policymakers to communicate clinical, humanistic, and economic evidence for ivonescimab. The role develops stakeholder relationships, supports formulary and pathway inclusion, collaborates with HEOR, medical affairs, and market access teams, communicates evidence gaps, and informs engagement strategies. Extensive healthcare and pharmaceutical experience, oncology knowledge, field-based market access expertise, and frequent travel are required.

Leads value-outcomes engagement with U.S. payers, health systems, pathway organizations, P&T committees, and policymakers. Provides objective clinical, economic, and humanistic information on ivonescimab; supports formulary, pathway, and treatment-order-set decisions; collaborates with medical affairs, HEOR, and market access teams; develops stakeholder relationships, communicates evidence, identifies evidence gaps, and informs access strategy. Requires extensive healthcare and pharmaceutical experience, oncology knowledge, field-based market access expertise, and up to 75% travel.

Owns Summit’s federal account strategy for VA, VHA, DoD, DHA, and TRICARE systems ahead of oncology portfolio launch. Responsibilities include federal contracting readiness, FSS contract and pricing management, formulary and pathway access, account planning, stakeholder relationship development, reimbursement navigation, evidence coordination, and compliance with federal pharmaceutical regulations. The role is a senior individual contributor expected to build and lead the federal function as the portfolio expands.

Lead global regulatory strategy for oncology programs from IND/CTA through BLA/MAA and post‑marketing. Provide cross‑functional regulatory leadership, lead due diligence for partnerships, mentor RA staff, drive labeling and risk‑mitigation strategy, liaise with global authorities, and support product launch activities with minimal oversight.

Lead global regulatory strategy and execution for oncology products, securing IND/CTA approvals and supporting BLA/MAA submissions. Provide regulatory leadership across regions, advise cross-functional teams on regulatory requirements, mentor RA staff, manage labeling activities, and interface with major regulatory authorities to ensure program success.

The Sr. Commercial Attorney will support the launch of Ivonescimab by drafting and negotiating commercial agreements, ensuring compliance with regulations, and advising on market strategies.