
Summit Therapeutics, Inc.
Remote Jobs
Summit Therapeutics’ mission is to resolve serious, unmet medical needs for the betterment of overall human health.
17 Jobs
Senior Manager, Clinical Site Partner
Summit Therapeutics, Inc.Summit Therapeutics’ mission is to resolve serious, unmet medical needs for the betterment of overall human health.
• Provide leadership and operational expertise in the execution of one or more Phase I–III clinical trials across the European region. • Ensure operational excellence in trial conduct and site performance. • Serve as the primary Summit operational point of contact for assigned clinical trial sites. • Drive study start-up efficiency and maintain high standards of performance and quality throughout the study lifecycle. • Act as a strategic partner to sites and study teams to deliver a concierge-level experience to our clinical trial sites. • Track key performance metrics to assess site progress, mitigate potential risks, and implement corrective actions.
Senior Manager, Clinical Site Partner
Summit Therapeutics, Inc.Summit Therapeutics’ mission is to resolve serious, unmet medical needs for the betterment of overall human health.
• Provide leadership and operational expertise in the execution of Phase I–III clinical trials across the US. • Serve as the main operational contact for assigned clinical trial sites across the Tri-State area. • Provide leadership and oversight for all operational aspects of site performance, from feasibility through study closeout. • Recommend sites based on indication, experience, capabilities, and local knowledge. • Drive efficiency in study start-up and expedite site activation timelines. • Maintain deep knowledge of site capabilities, processes, and requirements. • Act as a facilitator between Summit functions and site teams for communication and coordination. • Track key performance metrics to assess site progress, mitigate potential risks, and implement corrective actions.
Compliance Manager – Transparency
Summit Therapeutics, Inc.Summit Therapeutics’ mission is to resolve serious, unmet medical needs for the betterment of overall human health.
• Support the company’s transparency reporting activities in accordance with all applicable laws and company policies for Healthcare Providers (HCPs) and Healthcare organizations (HCOs) • Ensure correct reporting for all Transfers of Value (TOV) from the company to the reportable HCPs and support HCP dispute resolutions. • Achieve transparency monthly, quarterly, and annual reporting deadlines with accurately reported data as well as conduct weekly data scrubbing for submission into the reporting system. • Maintain up-to-date knowledge of Sunshine Act transparency reporting requirements to assess general data quality issues that may impact ability to report information to the applicable agencies. • Resource for day-to-day processes related to compliance with Sunshine Act Transparency, analyze and determine the best course of action for each inquiry/problem, while producing timely reports and providing supporting documentation for audits. • Support the implementation of transparency monitoring policies and procedures and training on them. • Provide support in the annual certification process. • Partner with multiple stakeholders throughout the Company (e.g., Legal, Clinical Operations, Medical Affairs, Sales and Marketing, HR, Internal Audit, QA) to manage and enhance an effective corporate compliance program and function and ensure that appropriate compliance policies, procedures, and internal controls are in place. • Develop, maintain and regularly assess key policies and procedures to mitigate identified risks and meet government and healthcare compliance requirements. • Ensure curriculum and training plans align with business needs and regulatory/legal requirements. • Understand relevant laws and regulations in key global markets to ensure that the Company’s policies and business practices align with such laws and regulations. • Assist with monitoring, auditing and enforcement of compliance efforts, including compliance monitoring activities; risk assessments and reviews of compliance risk areas to determine risk exposure; ongoing collaboration with key stakeholders to identify any issues of non-compliance; and summarize and report same to the Chief Compliance Officer or her designee. • Conduct and manage compliance investigations regarding allegations of law or company policy or ethical standards and prepare written reports on the findings of such investigations, as directed by the Chief Compliance Officer or her designee. Assist with the determination and implementation of corrective actions. • Collaborate with the Chief Compliance Officer or her designee and global team to continue to enhance a culture of ethics and compliance. • Serve as a resource and subject matter expert for all healthcare compliance related activities. • Lead on other projects as assigned from time to time. • All other duties as assigned.
Director – Market Access, Payer Accounts
Summit Therapeutics, Inc.Summit Therapeutics’ mission is to resolve serious, unmet medical needs for the betterment of overall human health.
• Establish, broaden, and deepen relationships with target entities (e.g., health insurers, PBM's, other payers, etc.) and key decision makers and influencers (medical and pharmacy directors, etc.) that affect coverage and reimbursement decisions. • Positively influence decision makers, policies, guidelines, and contracts to facilitate timely and appropriate coverage, access and reimbursement for our drug candidates and approved products. • Implement Brand access strategies and develop account specific plans and assist in the resolution of access/reimbursement issues. • Work closely with the Medical Affairs field team to support the communication and understanding of our drug candidates and approved products with payers. • Work closely with the Patient Services team to support the patient journey and resolve coverage issues. • Assist Regional Sales teams with pull- or sell-through strategies based on payer coverage. • Establish and maintain relationships with key decision-makers, including Formulary, P&T, and Pathway leaders, Medical & Pharmacy Directors and other population-based stakeholders to secure appropriate access and optimal product positioning. • Co-create account-level strategies, tools, and tactics to communicate the product value proposition effectively. Collaborate on pricing and contracting strategies, HEOR evidence generation plans, patient support programs, payer marketing initiatives, and account management approaches. • Lead discussions with internal and external partners to ensure alignment on access, coverage, and reimbursement strategies. • Foster a high-performance culture within the field team by promoting accountability, urgency, ethical behavior, and professional development. • Stay informed on healthcare industry trends, payer policies, reimbursement processes, and competitive activity. Provide strategic insights to inform decision-making, access strategies, and product launches. • Ensure all Market Access initiatives are developed and executed in compliance with legal, regulatory, and ethical standards. • Ability to work effectively in a fast-paced and dynamic environment, balancing multiple priorities and meeting deadlines.
Clinical Supplies Manager
Summit Therapeutics, Inc.Summit Therapeutics’ mission is to resolve serious, unmet medical needs for the betterment of overall human health.
• Develop and maintain accurate forecasts for clinical trial supplies based on protocol requirements and enrolment projections. • Collaborate with cross-functional teams to ensure alignment of clinical trial supply plans with study timelines and milestones. • Oversee relationships with external vendors, including clinical packaging and labelling partners, distribution centres, and courier services. • Monitor vendor performance, adherence to timelines, and quality standards. • Implement and maintain robust inventory management systems to track and manage clinical trial supplies throughout the supply chain. • Ensure adequate and timely supply of investigational products to clinical sites. • Oversee the planning, implementation and utilisation of effective clinical systems to support inventory management and distribution (e.g. IxRT). • Stay up to date on relevant regulatory requirements and guidelines related to clinical supply chain management. • Support regulatory strategy by overseeing provision of required documentation for submission and QP certification as required. • Ensure all activities comply with Good Manufacturing Practice (GMP) and other applicable regulations. • Identify potential risks and challenges in the clinical supply chain and develop mitigation plans. • Proactively address issues that may impact the availability of clinical trial materials. • Foster effective communication and collaboration with internal stakeholders, including Clinical Operations, Regulatory Affairs, Quality Assurance, and other relevant departments. • Participate in project team meetings to provide updates on clinical supply chain status and address any issues or concerns. • Contribute to monthly review cycles to ensure cross functional alignment on strategic and tactical topics. • All other duties as assigned
Corporate Account Director, GPO
Summit Therapeutics, Inc.Summit Therapeutics’ mission is to resolve serious, unmet medical needs for the betterment of overall human health.
• 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.
Associate Director, Biostatistics
Summit Therapeutics, Inc.Summit Therapeutics’ mission is to resolve serious, unmet medical needs for the betterment of overall human health.
• 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.
Director, Safety Physician
Summit Therapeutics, Inc.Summit Therapeutics’ mission is to resolve serious, unmet medical needs for the betterment of overall human health.
• Reporting to the VP of Patient Safety & Pharmacovigilance (PSPV), the Safety Physician Director will be responsible for investigational and marketed product pharmacovigilance activities. • Primary responsibilities include medical review of individual case safety reports (ICSRs), strategic input for adverse event monitoring and signal detection, ensuring global pharmacovigilance regulatory requirements are met, and safeguarding patients enrolled in our trials or administered our products. • Implement the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. Evaluate medical accuracy of ICSRs reports. • Prepare Analysis of Similar Events (AOSE) for IND safety reports. • Confirm criteria and content for expedited reporting and unblinding (e.g. SUSAR or urgent safety issues). • Lead or actively contribute to the preparations and presentation of safety information to the Drug Safety Committee (DSC), Product Safety Review Team (PSRT), Independent Data Monitoring Committees (IDMCs), and other internal and external stakeholders/parties, when required. • Interact and liaise with PV vendor medical reviewer and Summit Medical Monitors. • Review individual and aggregate safety data from safety database on a scheduled basis for signal detection. • Act as product lead and/or therapeutic area lead as assigned. • Share ICSR case quality issues with PV Operations as appropriate, and support Quality Assurance of ICSR medical review. • Implement appropriate case follow up / queries per SOPs. • Develop and support medical coding conventions, and systematic process improvements for ICSR medical review. • Support reconciliation between Safety and Clinical databases. • Develop, maintain, update, review and approve list of expected terms via the Reference Safety Information (RSI) in the IB, in collaboration with development partner and cross-functional teams. • Act as a Medical Safety Review process lead and support the development, training on and implementation of new processes in Medical Safety Review. • Mentor junior medical safety reviewers as needed and applicable, provide direct managerial responsibilities for medical safety reviewers on therapeutic or functional team. • Maintain a state of inspection readiness, and act as functional representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility. • Provide expertise and guidance on teams for interdepartmental and cross-functional initiatives including process improvement, standards development, Standard Operating Procedures (SOP) creation, and metrics with regards to medical safety review. • Author, review and/or approve safety content of various aggregate safety summary documents such as DSURs, PBRERs, Regulatory Response documents, Safety Signal Evaluation documents, etc., when requested. • Perform other duties related to the position as necessary as defined in SOPs or as requested by their supervisor. • All other duties as assigned.
Senior Manager, Clinical Site Partner
Summit Therapeutics, Inc.Summit Therapeutics’ mission is to resolve serious, unmet medical needs for the betterment of overall human health.
• Responsible for providing leadership and operational expertise in the execution of Phase I-III clinical trials across Europe. • Serve as the main operational contact for assigned clinical trial sites. • Provide leadership and oversight for all operational aspects of site performance. • Support feasibility assessments and site selection activities. • Drive efficiency in study start-up and expedite site activation timelines. • Act as a facilitator between Summit functions and site teams. • Track key performance metrics to assess site progress and mitigate risks. • Develop and deploy strategies to improve site engagement and performance. • Perform all other duties as assigned.
Senior Counsel, Employment
Summit Therapeutics, Inc.Summit Therapeutics’ mission is to resolve serious, unmet medical needs for the betterment of overall human health.
• 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
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