Jobs at Summit Therapeutics, Inc.

Supports regulatory activities for oncology drug development and clinical studies, including CTA, IND, BLA, NDA, and ex-US submissions. Coordinates submission preparation, review, approval workflows, health-authority interactions, regulatory timelines, trackers, archives, and responses. Collaborates with cross-functional teams, CROs, regulatory operations, and subject-matter experts while escalating risks and maintaining accurate documentation under the guidance of a Regulatory Affairs Lead.

Supports monthly close, R&D accounting, clinical trial accruals, CRO and investigator grant entries, and clinical site payments. Reviews invoices against agreements, maintains SOX controls, supports audits, prepares schedules, and ensures accurate financial reporting across Phase 2 and Phase 3 studies. The role collaborates with Clinical Operations and Study Start Up teams while improving processes, managing deadlines, and maintaining compliance.

Manages clinical pharmacology, pharmacokinetic, drug metabolism, and bioanalytical activities across drug development programs. Responsibilities include designing ADME studies, managing bioanalysis vendors, overseeing PK and ADA sample logistics, ensuring GCP compliance and data integrity, coordinating laboratories and chain of custody, and performing noncompartmental analysis and reporting. The role serves as a clinical pharmacology and DMPK subject matter expert on early- and late-stage cross-functional teams.

Lead portfolio and new-indication strategy for oncology, delivering market and competitive intelligence, forecasting/NPV models, market research, TPP alignment, and cross-functional strategic recommendations to inform executive decisions and BD opportunities.

Provides strategic and operational leadership across multiple pharmaceutical development programs, coordinating Research, Development, Regulatory, Manufacturing, Business Strategy, and external partners. Oversees milestones, governance, integrated plans, risks, budgets, scenario planning, executive reporting, and cross-functional decision-making. Leads late-stage solid tumor oncology programs and registrational trials, mentors program managers, and advances program management processes and organizational capabilities.

Lead development, implementation, and continuous improvement of IRT/RTSM standards for global clinical studies. Serve as SME and process owner for IRT processes, partner with cross-functional teams and vendors to deliver compliant, scalable solutions, create SOPs and training, and drive change control and inspection readiness.

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 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.

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.

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 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.

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.

Lead the regional launch and commercialization of an oncology product (ivonescimab) by executing sales strategy, recruiting and coaching oncology account managers, managing regional KPIs, partnering with cross-functional teams (Marketing, Medical Affairs, Market Access), building customer relationships, providing market and competitive insights, and ensuring compliant commercial execution while managing travel and resources to achieve sales and market share goals.

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.