Summit Therapeutics, Inc.

Director

• Independently cultivate and manage relationships with PBDMs, acting as primary point of contact and collaborating closely with other field roles to ensure an aligned approach to stakeholder engagement
• Collaborate with internal HEOR team and market access team, to execute on scientific engagement strategy for appropriate stakeholders (e.g., Payers, PBMs, GPOs, IDNs and Oncology Pathways) within a territory or customer base
• Serve as a conduit and resource for providing clinical and healthcare economic information (HCEI) to payers and formulary decision-makers
• Maintaining required knowledge of ivonescimab, to proactively and reactively communicate clinical and economic information related to ivonescimab to advance formulary decision-making and improve patient outcomes
• Capture and communicate internally key stakeholder insights and evidence gaps/needs including potential opportunities for collaboration
• Understand the medical affairs priorities to contribute to content strategy development and execute aligned field tactics
• Work with stakeholders to ensure inclusion of ivonescimab in clinical/payer pathways, and treatment order sets, while optimizing budget assessments.
• Collaborate effectively with medical affairs, HEOR, market access and other colleagues as appropriate in support of developing and implementing account engagement plan, providing input on scientific and value topics
• Understanding of principles of study design, methodology, data analysis, and interpretation to successfully communicate data to stakeholders
• Utilize and effectively present clinical, humanistic, and economic evidence as well as the value proposition in a clear and compelling manner to the payer audience
• Maintain understanding of market and payer needs in an increasingly complex and dynamic environment to drive actionable recommendations to inform medical and market access strategy
• All other duties as assigned

Director, Value Outcomes Liaison

• Lead global and regional HEOR strategies and evidence generation projects to support market access and product value.
• Collaborate with Medical Affairs and Market Access to integrate HEOR initiatives into broader strategies and stakeholder engagement plans.
• Oversee the development, review, and dissemination of high-quality HEOR outputs, including protocols, analytic plans, publications, and field materials.
• Provide training and develop relevant health care economic information (HCEI) materials to support field teams
• Support value demonstration tactics for Health Technology Assessment (HTA), including EU Joint Clinical Assessment (JCA) and payer assessments
• Maintain awareness of the quickly evolving global HTA and reimbursement landscape, help educate organization on developments within HEOR
• Ensure scientific rigor and strategic alignment in all evidence generation activities.
• Lead development of high-quality publications, posters, and presentations to communicate HEOR findings effectively
• Develop and maintain strong alignment with the managed care liaison team to obtain insights from external stakeholders and adjust evidence generation plans accordingly
• All other duties as assigned

Director, Health Economics – Outcomes Research

Compliance

• Work with assigned mentors on projects to improve leadership and problem-solving skills
• Assist with life-cycle regulatory activities
• Support projects overseen by regulatory leads

Regulatory Affairs Intern

Manager

• Lead and manage clinical data management activities for multiple oncology clinical trials, ensuring adherence to project timelines, budgets, and quality standards.
• Provide strategic oversight and direction to CRO clinical data management teams for assigned studies.
• Develop and implement data management plans, case report forms (CRFs), edit checks, and data validation plans in alignment with study protocols and regulatory requirements.
• Oversee the design, build, and validation of clinical databases using Medidata Rave EDC, ensuring optimal configuration and functionality.
• Conduct thorough reviews of clinical data, identifying trends, inconsistencies, and potential issues that may impact data quality or study outcomes.
• Collaborate with cross-functional teams including Biostatistics, Clinical Operations, Safety, and Regulatory to ensure alignment of data management strategies with overall clinical development goals.
• Lead the selection, oversight, and performance management of external data management vendors.
• Develop and maintain SOPs, guidelines, and best practices for clinical data management processes.
• Represent the Clinical Data Management function in internal and external meetings, providing expert guidance on data-related matters.
• Stay current with industry trends, regulatory requirements, and technological advancements in clinical data management, particularly in the oncology field.

Senior Manager, Clinical Data Management

• Lead process development/characterization, tech transfer and process validation for sterile drug product, including oversight of external CDMOs and internal teams.
• Partner with the broader CMC team to implement process, product, and site changes
• Support, with the team, successful execution of clinical and commercial batch manufacturing in alignment with the development and supply timelines.
• Be accountable, with the team, to successfully deliver CMC chapters to regulatory documents
• Actively support dialogue/interaction with regulatory agencies
• Support PLI/PAI preparation and delivery
• Responsible for all stages of Process Validation, including CPV (Continuous Process Verification), in accordance with governing quality system requirements.
• Prioritize post-approval opportunities and develop business cases for further investment/development
• Foster effective communication and collaboration with internal and external stakeholders, including other CMC functions, Regulatory Affairs, Quality Assurance, and CROs/CDMOs
• Collaboratively work across the broader CMC, regulatory and quality departments to deliver desired outcomes
• Collaborate cross-functionally with Regulatory, Quality, Supply Chain, and CMC teams to ensure integrated planning and execution.
• Ensure GMP compliance across all activities.
• Support audits and inspections.
• All other duties as assigned

MSAT Director – Drug Product

• The Director, Medical Information (MI) is a strategic leader responsible for building, scaling, and overseeing the MI function to ensure launch readiness and ongoing scientific excellence.
• Architect the full MI infrastructure including systems, processes, governance, and content strategy to support the company’s first commercial launch and future portfolio expansion.
• Lead to the end-to-end development and maintenance of MI capabilities that enable swift onboarding, integration, and operational readiness of the MI call center vendor.
• Collaborate cross-functionally with Medical Affairs, Regulatory, Safety, Clinical Development, Clinical Operations, Compliance, and Commercial partners.
• Serve as the internal expert on MI regulations, industry standards, and best practices.
• Develop external and internal MI SOPs, work instructions, training materials, and quality monitoring processes.
• Ensure readiness and adherence to the internal and external audits is always maintained.
• Oversee the development, review, and approval of Standard Response Letters (SRLs), Custom Responses (CRs), and Frequently Asked Questions (FAQs).
• Establish and manage MI dashboards to track inquiry trends, operational performance, and scientific insights.

Director, Medical Information

Clinical Research

• Leads/Contributes to study design and amendments in collaboration with internal and external scientific stakeholders
• Collaborates with MD, regulatory and other internal partners/stakeholders with authoring and submission of protocols, protocol amendments, regulatory filings, and other regulatory documentation
• Collaborates with clinical operations, data management and CRO to develop and implement the overall data quality plan and leads internal medical data review and safety trend analysis on one or more studies/programs
• Point-of-contact for clinical inquiries from CRO medical monitor and other stakeholders
• Develops and provides input for clinical presentation slides and other materials for internal/external meetings and/or ongoing communications (e.g., investigator meetings, pre-study site selection visits, study coordinator or clinical research administrator training, study newsletters, communications to study sites, etc.)
• Partners with clinical operations and CRO in developing and maintaining study start-up documents/resources (e.g., ICF, Lab Manual, EDC, Safety monitoring Plan, etc.)
• Participates in safety meetings and tracks, analyzes, and reviews documentation for any potential safety events
• Leads/Contributes to the development and implementation of communications strategies to support existing and concluded studies. Includes KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials
• Writes and/or reviews abstracts, posters, content for scientific meetings, conferences, other events and presentations, and other publicly distributed materials and coordinates further reviews with internal partners and stakeholders
• Coordinates submissions to scientific meetings and/or other appropriate venues or groups
• Writes clinical science sections of meeting packages and assists in the development and review of other clinical documentation required for regulatory submissions and other regulatory processes
• All other duties as assigned

Director, Clinical Scientist

• Develop and lead the US medical affairs strategy for lung cancer
• Oversee the design, execution, and reporting of medical activities
• Mentor, coach, and develop direct reports
• Establish and maintain relationships with KOLs, HCPs
• Ensure effective communication of scientific data
• Oversee the development and execution of medical education programs
• Collaborate with Clinical Development, Regulatory, Commercial teams
• Monitor and report on activities and performance metrics

Executive Director, Global Medical Affairs – Lung

Accounting Manager

• Support the monthly close process to ensure timely and accurate financial reporting, with a focus on continuous process improvement and reducing close timelines
• Prepare and review high visibility CRO entries, Investigator Grant entries, and other R&D entries
• Own/review the accounting and financial tracking for clinical trial accruals, working closely with cross-functional teams to ensure the data is complete, accurate, and audit-compliant
• Lead site payments process with 3 rd party vendor clinical sites by reviewing invoices, checking them against Clinical Trial Agreements (CTAs), working with the Clinical Operations team and resolving any issues quickly and timely
• Collaborate cross-functionally with other teams like Clinical Operations, Vendor Management and Legal to support strategic business objectives and ensure the accuracy of financial information
• Maintain and monitor SOX controls related to operational accounting are completed on time and are working as intended. Proactively identify and escalate any control deficiencies
• Support financial systems optimization and upgrades, including implementing systems/tools and making the most of Netsuite and Coupa
• Assist with audit preparation by gathering needed documents, preparing schedules (PBCs), and responding to audit requests
• All other duties as assigned

Accounting Manager – R&D

Program Manager

• Lead the cross-functional program management team to maximize the value of Summit's pipeline drug candidates.
• Drive execution of development plans from clinical trials to regulatory approval filings and commercialization.
• Establish and maintain an integrated project plan to cover all aspects of the development program.
• Motivate and determine accountability among team members.
• Report and present program information to the Executive Committee and other key stakeholders.
• Drive decision-making for development of the pipeline candidates.

VP, Program Management

Clinical Operations

• Lead global execution of multiple Phase IIIII clinical trials in oncology (non-lung)
• Build, manage, mentor, and provide line management for Clinical Operations staff (>20 members with skip reports), including study management team leaders, clinical trial managers, CRAs and contractors
• Directly manage the global Study Start-Up team, overseeing essential documents, site budgets, and site contract negotiations
• Establish and drive SSU performance metrics, including site activation cycle times, essential document completeness, and budget and contract turnaround time
• Monitor progress, enrollment, quality, timelines, and budgets across multiple concurrent studies; proactively manage risks
• Timely escalation of risks to the Head of Clinical Operations.
• Lead CRO governance, including selection, contracting, performance monitoring, KPIs, risk management, escalation pathways, and executive reviews to ensure quality, timelines, and budget adherence
• Manage and oversee Randstad Services providing unblinding monitoring support, ensuring compliance, quality, timelines, and clear separation of blinded and unblinded activities
• Partner cross-functionally with Clinical Development, Medical Affairs, Regulatory, Biometrics, Safety, CMC, Quality, and Project Management across regions
• Support SOP development, review, and implementation to ensure consistency, compliance, and inspection readiness across clinical operations
• Support preparation of clinical components for global regulatory submissions and health authority inspections
• Implement fit-for-purpose global clinical operations processes, metrics, and oversight models appropriate for a growing biotech company
• Partner with Business Operations and IT to identify and implement technological solutions to replace manual processes and improve data transparency.
• All other duties as assigned

Executive Director – Clinical Operations

Executive Director, Clinical Operations

• Lead and support upstream process design, optimization, troubleshooting, and tech transfer for drug substance manufacturing.
• Drive process development, characterization, validation, and risk management across internal teams and external CDMOs.
• Collaborate cross-functionally with QA, RA, supply chain, and CMOs; provide clear updates to project leadership.
• Contribute to regulatory documentation and support CMC programs and sub-teams.
• Support BLA filing and related activities, including responding to RFIs, preparing for PAI, PAS submissions, annual product reviews, and other regulatory commitments.
• Resolve upstream manufacturing issues and facilitate problem-solving and contingency planning.
• Promote continuous improvement for process robustness, efficiency, and scalability.
• Oversee tech transfer and manage deviations, change controls, and risk assessments.
• Travel as needed for tech transfer, scale-up, and external collaboration.
• Perform all other duties as assigned.

Senior Manager, Upstream MSAT

Controller

• Oversee all aspects of accounting, including general ledger, cost accounting, accounts payable and payroll.
• Drive the preparation and review of clinical trials and contract manufacturing related accrual and prepayment entries and reconciliations.
• Perform / review various technical accounting analyses.
• Maintain internal and operational controls necessary to monitor performance and comply with SOX 404, as required.
• Ensure completeness and accuracy of month-end close tasks; is accountable for overseeing journal entries, balance sheet reconciliations, financial flux, key judgements, internal controls and management reporting.
• Act as primary liaison with external auditors; prepare and coordinate all appropriate material for quarterly reviews and annual audits.
• Collaborate with supply chain, manufacturing, and quality teams to oversee and monitor drug inventory accounting, ensuring accurate valuation, inventory reconciliation, obsolescence and excess stock inventory practices and proper compliance.
• Partner with FP&A and the business to provide financial insight for budgets and forecasting.
• Assist with compilation of information for preparation of tax compliance items, including but not limited to annual provisions/returns and other tax-related items and review the external tax advisors deliverables.
• Maintain focus on continuous improvement by challenging status quo to accelerate financial accounting close and increase efficiency of accounting and reporting processes.
• Support ERP implementation and upgrades as appropriate.
• Develop and updated accounting policies and documentation.
• Mentor and support members of the accounting team.
• Other duties as assigned.

Assistant Controller

• Serves as the study-level biostatistician including reviewing protocol, conducting sample size calculations, developing statistical analysis plan, data presentation plan, and Data Monitoring Committee (DMC) charter
• Partners with cross-functional team members in ensuring accuracy/consistency of clinical data and exceptional delivery, interpretation of clinical results
• Assists in the development and review of regulatory submission documents
• Implements biostatistics department policies, standards, procedures, and work instructions