Summit Therapeutics, Inc.

Director

• 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, and assists in the development and review of regulatory submission documents.
• Implements biostatistics department policies, standards, procedures, and work instructions.

Associate Director, Biostatistics

Account Executive

• Reporting directly to the Executive Director, GPO & Strategic Accounts, the Corporate Account Director, GPO is responsible for establishing and maintaining strategic relationships that secure optimal market access for Summit Therapeutics’ innovative oncology medicines across Group Purchasing Organizations (GPOs), key community oncology stakeholders, and provider-driven clinical pathways.
• Develop and execute strategic account plans designed to support rapid product adoption through clinical pathway and treatment protocol inclusion, while representing Summit Therapeutics with key executive decision-makers across major oncology networks and aggregators.
• Coordinate cross-functional collaboration across Commercial, Medical Affairs, Legal, Marketing and Market Access to ensure alignment and successful integration of Summit’s therapies within provider-driven pathways.

Corporate Account Director, GPO

• Serves as the project level biostatistician and provides leadership within biostatistics function to develop and execute statistical strategy, study design, statistical analyses, and regulatory submissions for clinical trials in oncology.
• Partners with clinical science, regulatory and other team members in clinical development plans, authoring key clinical/regulatory/statistical documents, and ensuring exceptional delivery and interpretation of clinical data.
• Develops and implements biostatistics department policies, standards, procedures, and work-instructions in coordination with department leader and other functions.
• Represents biostatistics function in interactions with CROs, institutional review boards, and regulatory agencies.
• Provide technical leadership and statistical support to clinical development through the design and conduct of clinical studies in oncology.
• Support/contribute to protocol development to ensure appropriateness of trial design, sample size, and propose the use of meaningful and efficient statistical methodologies.
• Lead development of statistical analysis plans, data presentation plans, clinical development plans, biometrics related submission activities, and post-submission strategies/responses.
• Review the accuracy of clinical data, perform statistical analysis, interpret study results, and collaborate with clinical team and other team members to produce interim reports, final reports, and publications.
• Write/review sections of meeting packages and assist in the development and review of other documents required for regulatory submissions and other regulatory processes.
• Review vendor data transfer specifications and ADaM programming specifications.
• Lead assessment and introduction of novel statistical methodologies to implement solutions.
• Represent biostatistics function or biometrics department in cross function teams.
• Work with department leader to develop and implement department policies, standards, and procedures.
• Collaborate with clinical operations, data management and CRO to develop and implement CRFs, database design, and the overall data quality plan.
• Evaluate and manage CROs and other vendors, including scope-of-work, timelines, deliverables and budgets.
• Provide strategic statistical and regulatory guidance to anticipate challenges, mitigate risk, and ensure project success.
• Attend meetings with FDA or other health authorities to ensure ongoing agreement on project development.
• All other duties as assigned.

Director, Biostatistics

General Counsel

• Collaborate with attorneys and other legal staff in other practice areas to proactively identify and address key legal issues for the business teams.
• Draft, review, analyze and negotiate clinical related contracts, including clinical trial agreements (including ancillary agreements, such as clinical study service agreements, quality agreements, and pharmacy and radiology agreements), investigator sponsored studies (ISTs), collaboration and development agreements, sponsored research agreements, and agreements with contract research organizations (CROs). In addition, may draft and negotiate consulting agreements, master services agreements and related statements of work, promotional speaker bureau agreements, vendor and service contracts and related work orders, IT software license agreements, HR benefit and contractor agreements, leases, and confidentiality or non-disclosure agreements.
• Liaise between the internal business units and external parties, ensuring that all legal and contractual matters are addressed efficiently and promptly; escalate matters, as necessary, to reduce company risk and help ensure company business objectives are met.
• Promptly respond to complex inquiries regarding contract obligations and revisions
• Identify risks and issues, propose alternatives that meet company business objectives while also reducing company risk
• Reviews and tracks in-process and on-going agreements
• Supports company employees regarding the Contract Management process
• Interacts with Intellectual Property Counsel to ensure appropriate handling of intellectual property issues in agreements
• Interacts with Regulatory Counsel and Compliance to ensure appropriate handling of regulatory/compliance issues in contract matters
• Interacts with Quality Assurance to ensure appropriate handling of quality matters.
• Prepare template agreements, modify existing templates and prepare unique agreements as required
• Ensure clear and prompt communication with company employees, and outside parties regarding status of, or issues in, contracts
• Handle miscellaneous legal tasks or special assignments on an as-needed basis
• All other duties as assigned

Corporate Counsel, Clinical Contracts

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

• Serve as the company’s primary legal advisor for contracts, with input from the CLO and General Counsel, in the negotiation of contracts across all departments, including clinical operations, R&D, medical affairs, business development, human resources, IT, finance, manufacturing, quality, commercial and facilities
• Pro-actively update company guidelines, policies, SOPs related to contract review and processes for efficiency, effectiveness, and changes to applicable law; ensure the Contracts Team and relevant business departments are trained on any new policies and procedures
• Draft, review, analyze and negotiate clinical related contracts, including clinical trial agreements (including ancillary agreements, such as clinical study service agreements, quality agreements, and pharmacy and radiology agreements), investigator sponsored studies (ISTs), strategic clinical trial collaboration agreements, sponsored research agreements, and agreements with contract research organizations (CROs). In addition, may draft, review and negotiate financing agreements, collaboration and partnership agreements, consulting agreements, master services agreements and related statements of work, promotional speaker bureau agreements, vendor and service contracts and related work orders, IT software license agreements, HR benefit and contractor agreements, leases, and confidentiality or non-disclosure agreements.
• Supervise and promptly address contract escalations from more junior attorneys and paralegals in the review and negotiation of contracts ensuring compliance with all Legal Department guidelines, policies and procedures
• Review and revise Legal Department guidelines, policies and procedures related to the contract review lifecycle (intake, review and negotiation, execution).
• Serve as the legal liaison between the internal business units and external parties, ensuring that all legal and contractual matters are addressed efficiently and promptly; escalate matters to the General Counsel, as necessary, to reduce company risk and help ensure company business objectives are met.
• Promptly respond to complex inquiries regarding contract obligations and revisions
• Identify risks and issues, propose alternatives that meet company business objectives while also reducing company risk
• Actively seek feedback and advice from IP Counsel, Regulatory Counsel, Commercial Counsel, and the Compliance Department to ensure efficient and appropriate handling of relevant issues in agreements
• Work with Quality Assurance to ensure appropriate handling of quality matters.
• Prepare template agreements, modify existing templates and prepare unique agreements as necessary to ensure compliance with applicable law and internal guidelines; ensure the Contracts Team is timely informed and trained on any revised templates and contracting processes
• Oversee the company’s CLM for the Legal Department; propose continuous process improvements and work with the IT Department to make any necessary changes and provide necessary training to the Contracts team and other departments
• Ensure clear and prompt communication with company employees, and outside parties regarding contract status and any outstanding issues
• Handle miscellaneous legal tasks or special assignments on an as-needed basis
• All other duties as assigned

Assistant General Counsel, Clinical

• Provide legal advice/consultation on matters related to employee, human resources, and employment matters
• Draft and review employment related documents such as offer letters, employment contracts, separation agreements, restrictive covenants, employee handbooks, SOPs, and objectives relative to employment law
• Partner with HR & the business leaders for business-focused solutions that manage risk
• Advise and train managers on employment law issues; such as corrective action, documentation practices, and performance improvement plans.
• Review and negotiate human resources and employment related agreements, including benefits, ERISA, placement, agency/EOR, and employment agreements
• Draft, review, negotiate G&A MSAs, SOWs, and Service Agreements, including Finance, IT, Facilities, and leases
• Stay updated on changes in employment law to provide informed advice
• Advise on and conduct, as necessary, workplace investigations, terminations, and corrective actions.
• Partner with HR to develop strategies to mitigate litigation risks and proactively resolve disputes.
• Advise on the administration, and compliance of retirement benefit plans, such as profit-sharing, 401(k), and welfare benefit plans
• Advise on the resolution of compliance issues and other technical matters that arise in the day-to-day administration of employee benefit plans and programs
• Manage and oversee employment related claims, litigation, arbitration, agency charges as well as outside counsel
• Develop trusted partner relationships with stakeholders
• Support global operations with international employment law issues, including cross-border compliance and expatriate assignments.
• Handle miscellaneous legal tasks or special assignments on an as-needed basis

Senior Counsel, Employment

• 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

Attorney

• Lead the drafting and negotiation of the agreements associated with the Company’s commercial activities.
• Draft and negotiate pricing, distribution, payer, and reimbursement agreements.
• Support government program contracting, including Medicare and Medicaid.
• Review, negotiate, and draft general Master Services Agreements and related documents.
• Develop template agreements that support the Company’s commercial activities.
• Advise on the legal structure of limited distribution networks for specialty drugs.
• Ensure compliance with federal and state laws related to distribution practices.
• Partner with commercial teams on reimbursement and assistance programs for medications.
• Work with internal Compliance team to ensure contracts comply with applicable laws.
• Establish and serve on relevant company committees to support commercial activities.
• Provide legal advice for formulary placement and managed care agreements.
• Monitor regulatory changes affecting pharmaceutical commercialization.
• Provide training for internal stakeholders on legal topics related to commercialization.

Senior Commercial Attorney, Transactions

Analyst

• Drive clinical studies in the field of oncology
• Collaborate with global teams to improve quality of life and resolve unmet medical needs

Principal Statistical Analyst

Medical Director

• Oversee global Phase 3 clinical trials and BLA filings
• Develop and execute integrated clinical trial programs including protocol design and medical oversight of new or ongoing studies
• Obtain scientific advisory input and work with biostatisticians for phase 3 design and analyses
• Support regulatory interactions for product advancement
• Work closely with clinical operations to provide advice and decision making regarding medical input to achieve operational excellence
• Play a pivotal role in leading investigator engagements including travel to support face-to-face interaction and protocol training
• Provide medical insight across a myriad of functions from discovery to manufacturing as needed
• Make vital contributions on pivotal programs in clinical development program
• Direct human clinical trials, phases 1-3, for lead candidate in development
• Participate in medical review of adverse event reports and monitoring of incoming safety data in conjunction with product safety/pharmacovigilance
• Coordinate and develop information for reports submitted to FDA, EMA, PMDA, and government, regulatory, or partner agencies
• Presentations to various external stakeholders - regulators, governing and harmonization bodies, principal investigators, scientific conference attendees, advisors and opinion leaders.

• Oversee global Phase 3 clinical trials and BLA (Biologic Licensing Application) filings
• Develop and execute integrated clinical trial programs including protocol design and medical oversight of new or ongoing studies
• Obtain scientific advisory input and work with biostatisticians for phase 3 design and analyses
• Support regulatory interactions for product advancement
• Provide medical insight across a myriad of functions from discovery to manufacturing
• Lead investigator engagements and participate in face-to-face interaction and protocol training
• Manage teams to execute on clinical development goals
• Participate in medical review of adverse event reports and safety data monitoring
• Coordinate and develop information for reports submitted to FDA, EMA, PMDA, and other agencies
• Presentations to external stakeholders including regulators and scientific conference attendees.

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

Associate Director, Biostatistics

Corporate Account Director, GPO

Director, Biostatistics

Corporate Counsel, Clinical Contracts

Assistant Controller

Assistant General Counsel, Clinical

Senior Counsel, Employment

Director, Health Economics – Outcomes Research

Senior Commercial Attorney, Transactions

Principal Statistical Analyst

Medical Director

Medical Director

Director, Clinical Scientist