Jobs at Summit Therapeutics, Inc.

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.

Lead execution of HCP promotional strategy for NSCLC, translating clinical data into compliant, field-facing materials and engagement experiences. Partner with Sales, Medical, Legal, Market Access, and Insights to enable field training, congress activities, and messaging optimization. Manage multiple workstreams in a launch-focused environment and travel as needed to support key events.

Lead operational planning and execution for global Phase II/III oncology trials, manage CROs/vendors, ensure GCP/ICH compliance and inspection-readiness, control budgets and TMF quality, mentor clinical operations staff, and drive cross-functional collaboration and risk mitigation to deliver studies on time and within budget.

Provide administrative and operational support for global oncology clinical studies, including meeting logistics and minutes, eTMF and CTMS management, vendor/CRO coordination, site start-up support, document control, study trackers, budget tracking, and process improvement to ensure compliance with ICH-GCP, FDA regulations, and company policies.

The Associate Director of Biostatistics provides statistical support for clinical trials in oncology, overseeing study design, analysis, and regulatory submissions while collaborating with cross-functional teams.

The Director of Biostatistics leads statistical strategy and analysis for clinical trials in oncology, collaborating with clinical teams and regulatory bodies.

Lead payer-account strategies to secure coverage, reimbursement, and patient affordability for oncology products. Build and manage relationships with payers (health plans, PBMs, Medicare, Medicaid, VA/DoD), develop account-level access plans, collaborate cross-functionally (Medical Affairs, Patient Services, Sales), influence formulary and contracting decisions, and ensure compliance while supporting product launches and field teams.

Lead regional clinical operations for Phase I-III oncology trials across the Middle East. Drive country start-up strategy, site activation, stakeholder engagement, regulatory approvals, feasibility, enrollment, timelines, budget, quality, and inspection readiness. Serve as senior escalation point and represent the company externally to investigators, regulators, and institutions.

Lead regional clinical operations for Latin America oncology trials, driving country startup, site activation, regulatory engagement, feasibility, enrollment, quality, timelines and budgets. Build investigator relationships, influence stakeholders and represent the company externally while ensuring GCP and inspection readiness.

Lead bioinformatics strategy and teams to analyze multiomic, imaging, and clinical data for biomarker discovery, patient stratification, CDx support, and AI-enabled predictive modeling across discovery and clinical programs.

Lead and perform statistical programming for oncology clinical trials: develop and validate SDTM/ADaM datasets, produce TLFs, consolidate data sources, implement CDISC standards, create regulatory documentation, mentor programmers, manage project timelines and quality, and support regulatory submissions.

The Senior Director of Sales Operations will build and lead commercial infrastructure for oncology sales, oversee operations, analytics, and education to maximize performance and compliance.

The Accounting Manager oversees R&D accruals and expenses for non-clinical trial activities, ensuring accurate financial reporting and collaboration with internal teams and vendors.

The Senior Manager of Regulatory Affairs oversees regulatory activities for clinical trials, prepares submissions, manages timelines, and ensures compliance with regulatory standards in the oncology sector.

Lead identification, evaluation, and execution of strategic partnerships and licensing in oncology. Drive deal processes, diligence, contracting, alliance management, cross-functional alignment, and executive communications to advance external innovation and joint clinical trials.

Lead study-level risk-based quality management for global Phase II/III oncology trials. Develop RBQM plans, KRIs, QTLs, centralized monitoring, risk assessments, and mitigation. Coordinate cross-functional risk reviews, site surveillance, CAPA support, inspection readiness, and CRO oversight to protect participant safety, data integrity, and regulatory compliance.

Lead regulatory review and strategy for advertising, promotional and non-promotional materials. Provide expert FDA-focused ad/promo guidance, review materials in Veeva, participate in MRC/PRC, submit branded promotions (Form 2253), liaise with OPDP, implement compliant processes, negotiate cross-functionally, and may manage direct reports while supporting regulatory affairs leadership.

Lead clinical data management for oncology trials from early to late phase, overseeing eCRF/CRF design, database development/validation, data review, query management, CRO/vendor oversight, regulatory compliance, audits, team management, and cross-functional coordination to ensure high-quality clinical trial data delivery.

Lead downstream MSAT activities for biologics (ivonescimab), providing technical oversight of process development, validation, tech transfers to CDMOs, troubleshooting, change control, and regulatory support. Collaborate cross-functionally to ensure robust scale-up, continuous process verification, and successful CMC deliverables.

Manage feasibility, site agreements, budgets, and activations for global Phase 2/3 oncology trials. Negotiate contracts and budgets, partner with Legal/Finance/CROs, oversee site payments and FSP providers, and drive Study Start-Up strategy, process improvements, and KPI reporting to enable timely site activation.