Summit Therapeutics, Inc.

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

Director, Clinical Scientist

• Leads/Contributes to study design and amendments
• Collaborates with internal and external partners for authoring protocols and regulatory documents
• Develops and implements the overall data quality plan
• Acts as point-of-contact for clinical inquiries from CRO medical monitor

• Help oversee global 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, work with biostatisticians for 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.
• Serve as a key medical expert for multiple cross functional teams.
• Provide medical insight across a myriad of functions from discovery to manufacturing.
• Lead investigator engagements including travel to support face-to-face interaction and protocol training.
• Serve as a leader on one or multiple, potentially pivotal, programs.

Associate Medical Director

Software Engineer

• Drive multiple drug discovery programs concurrently, ensuring efficient progression from conceptual design to the selection of clinical development candidates, meeting aggressive project timelines.
• Lead the design, development and engineering of novel protein therapeutics, including antibodies and bispecific/multimeric molecules, to enhance function, stability, safety and developability for oncology applications.
• Utilize molecular engineering approaches driven by AI/ML, novel display technology, directed evolution and structure-guided design, to optimize protein candidates.
• Perform hands-on protein expression in transient eukaryotic systems (e.g., HEK293, CHO cells) and generate stable expression cell lines.
• Execute protein purification using various chromatography techniques (affinity, IEX, SEC, etc.) and FPLC/HPLC systems.
• Conduct comprehensive analytical and functional characterization of engineered proteins using techniques such as SDS-PAGE, ELISA, flow cytometry, SPR/BLI, and endotoxin measurement.
• Collaborate with cross-functional teams to drive projects from target validation through candidate nomination.
• Troubleshoot experiments, develop new protocols, and document findings in electronic lab notebooks and technical reports.
• Present data and research updates effectively at internal meetings and external scientific conferences.
• Stay current with the latest advancements in protein engineering, cancer biology, and immunotherapy to propose and implement innovative technologies.

Director of Protein Engineering

Content Writer

• Prepare, edit, and finalize clinical/regulatory documents, including protocols/protocol amendments, clinical study reports (CSRs), Investigators Brochures, briefing documents, Module 2 clinical summary documents, and other regulatory submissions as needed
• Interact with document authors, contributors, and reviewers (including members of Biometrics, Clinical Operations, Clinical Development, Drug Safety, and Regulatory Affairs) to acquire necessary input into documents
• Manage the document review process and schedule and conduct meetings to ensure documentation timelines are achieved
• Manage medical writing timelines for assigned documents to ensure on-time deliverables that meet business needs
• Facilitate comment resolution and adjudication with authors, reviewers, and project teams
• Participate in the refinement of medical writing processes, SOPs, work instructions, templates, and style and content guides to ensure efficient preparation of high-quality medical writing deliverables

Senior Manager, Medical Writing

Marketing Operations

• Define and own the marketing operations operating model to support brand, portfolio, and commercial goals
• Serve as a trusted advisor to senior commercial and marketing leadership on operational best practices, risk mitigation, and scalability
• Develop and manage the marketing operations framework, including processes, timelines, workflows, and governance across brand and digital operations initiatives
• Serve as the operational conduit between Marketing, Digital Strategy, Medical, Legal, Regulatory, and external vendors/agencies
• Collaboratively develop and implement cross-functional standard operating procedures (SOPs) for marketing operations execution and compliance
• Drive operational excellence by identifying inefficiencies, implementing best practices, and continuously improving workflows
• Provide oversight for digital operations execution, including but not limited to, marketing CRM, marketing automation, email, and omnichannel campaign execution
• Partner across Commercial Operations, IT, and Data teams to implement, and optimize marketing technology platforms (e.g., Veeva, Salesforce, DAM, CMS)
• Ensure consistent, compliant execution of digital assets across channels and brands
• Champion operational readiness for new digital capabilities and evolving omnichannel strategies and tactics

Director, Marketing Operations

Operations

• Manage the implementation of all operational components for medical affairs projects, including coordinating and negotiating CDAs, contracts, and sponsorship agreements with both external vendors and internal stakeholders
• Collaborate with compliance and finance teams to ensure that thorough Fair Market Value assessments are performed on all external payments in accordance with company and industry standards
• Uphold precise documentation and reporting practices to promote compliance and transparency, ensuring adherence to regulations such as FMV and the Sunshine Act
• Design and roll out operational policies, procedures, and best practices aimed at enhancing efficiency, quality, and regulatory compliance across Medical Affairs operations
• Evaluate vendor proposals, statements of work, and contracts for their operational viability and cost-effectiveness
• Manage and track vendor SOWs against actual work performed and verify vendor invoices working closely with finance for payment
• Lead the development of metrics tracking and dashboards to provide leadership with updates on project progress, key performance indicators, and outcomes
• Foster clear and effective communication among internal teams, external stakeholders, and field medical staff to support unified and efficient execution of Medical Affairs activities
• Stay informed about industry developments, changes in regulations, and emerging best practices to drive continuous improvement within Medical Affairs operations
• Act as a central point for resolving issues, managing risks, and escalating operational challenges as needed
• Assist in organizing advisory boards, patient advocacy programs, congress (national and regional) planning, and other significant Medical Affairs initiatives and events
• Take part in strategic planning, contributing ideas to help shape the future direction of Medical Affairs within the organization
• Proactively seek opportunities for process improvements and lead initiatives to achieve operational excellence in Medical Affairs
• Use data analytics and stakeholder feedback to measure program success and suggest enhancements that meet organizational objectives and regulatory obligations
• Work closely with IT partners to enable digital transformation and integrate systems supporting Medical Affairs functions

Associate Director, Medical Affairs Operations

Manager

• Independently manage all operational aspects of studies, including protocol/consent review, document management, fair market value evaluations, contract execution, drug shipments, and maintain ongoing oversight of project to ensure timelines and team goals are met
• Manage the concept proposal intake process, maintain the submission portal and review status, document decisions and communicate with investigators and research coordinators
• Assist with agenda and prepare meeting materials/minutes for Scientific Review Committee meetings
• Responsible for obtaining internal approval of associated study budget, perform Fair Market Value analysis, conducts budget negotiations when needed
• Work closely with Regional Medical Science Directors (RMSDs)/Medical Science Liaisons (MSLs), principal investigators, and other external parties to maintain central progress tracker for all approved proposal to ensure study timelines are met
• Support ongoing analyses, tracking and reporting of study progress versus timelines committed by investigator, data delivery and program impact, and other related metrics
• Track achievement of milestone that trigger payment, and work with Finance to perform budget reconciliation as well as forecast future milestone
• Work with study site/drug supply team to manage and forecast drug supply for the program
• Participate in cross-functional team meetings to provide updates on the program and address any issues or concerns
• Collaborate cross-functionally with internal stakeholders, including medical affairs, clinical development, regulatory, drug supply, etc.
• Adheres to all relevant processes, trainings, and SOPs to ensure consistency, efficiency, and compliance.
• Continued process improvements to ensure consistency, efficiency, and compliance.

Senior Manager, Global Data Generation

Analyst

• Responsible for supporting and/or leading the statistical programming activities for clinical trial data collection, analysis, reporting, visualization on all Summit drugs
• Produce, review program codes and suggest alternative solutions that may be efficient
• Allocate resource for project, manage project timeline, control quality of deliverables and ensure compliance of procedure
• Work closely with Biostatistics to implement statistical analysis of clinical trial data
• Consolidate heterogeneous data source to prepare analysis-ready datasets supporting a particular project
• Perform compliance check and resolve any compliance issue during the process
• Create documentation for regulatory filings including reviewers guides and data definition documents
• Perform data analysis, statistical analysis, generate safety and efficacy tables, figures, and listings using SAS

Principal Statistical Analyst

Marketing

• Lead the overall (multiple indications) US Lung HCP Marketing strategy and launch execution, including messaging and go to market planning across HCP and account segments
• Drive commercial launch readiness and ensure alignment across Medical Affairs, Market Access and Sales and Marketing Operations
• Partner with Omnichannel and Patient leads to ensure alignment with brand strategy across tactics
• Lead a team of marketers who are individually laser focused on specific NSCLC indications and take responsibility for achieving cohesion at the brand level for NSCLC indications
• Translate complex clinical and scientific data into compelling, differentiated brand narratives that resonate with stakeholders
• Oversee marketing campaigns, content creation and tactical planning
• Partner closely with Sales Leadership and Field Teams to translate brand strategy into actionable field tactics, tools, and messaging that drives executional excellence
• Work with field insights and analytics to identify market opportunities, feedback trends, and competitive intelligence to continuously refine brand tactics
• Develop and maintain relationships with key stakeholders, including healthcare providers, payers, and advocacy groups
• Manage budget, agencies, and vendors to ensure high-quality, efficient execution and fiscal discipline
• Lead, mentor and empower cross-functional teams, fostering a collaborative and high-performing culture
• Travel as needed (25%) to support business priorities and engage with key stakeholders.

Executive Director, HCP Marketing – Lung Lead

Director

• Oversees managing statistical programming projects and creating strategic plans related to clinical trials and medical affairs publications.
• Leads the team in developing, maintaining, validating and running SAS programs that analyze and report clinical trial data.
• Responsible for the structure of the statistical programming function and representing the function in cross-functional activities.
• Provides technical and/or operational leadership in the delivery of high quality and timely statistical programming for clinical studies, drug programs, and/or in support of NDA submissions.
• Works closely with Biostatistics to implement statistical analyses of clinical trial data and develops ADaM specifications and datasets.
• Manages internal and vendor statistical programming support; Maintains collaboration with preferred vendors.
• Writes SAS programs that produce or validate tables, listings, figures, and analysis datasets, in support of clinical studies.
• Performs, plans, and coordinates project work to ensure timely, quality delivery across multiple projects.

Director, Statistical Programming

Compliance

• Provide ownership of molecule and study-level regulatory activities, including global clinical trial applications (CTAs) and IND submissions
• Review and approval of investigator document packages and associated FDA submissions, and manage other regulatory aspects of the studies as necessary
• Contribute and drive the regulatory content and strategy for BLA, NDA or marketing authorization submissions
• Provide regulatory guidance internally on study-team decisions
• Update study team of regulatory activities in the context of study team management meetings
• Manage and track queries and commitments with regulatory agencies, collaborate with subject matter experts to provide written responses to queries, provide periodic status updates regarding unfulfilled conditions/commitments
• Collaborate with cross-functional study team for planning of regulatory documents, including health authority meetings and responses to health authority queries
• Support processes by which regulatory submissions are reviewed, finalized, and signed-off
• Manage the record of regulatory/ethics submissions and approvals across all studies
• Manage document archive processes
• Support global regulatory submissions and strategic planning as applicable
• All other duties as assigned

Senior Manager, Regulatory Affairs

• Independently oversee all operational aspects of non-sponsored research studies
• Deliver comprehensive end-to-end management
• Responsible for identifying key data gaps and developing strategies
• Develop metrics and dashboards to monitor the progress and impact of data generation initiatives
• Foster and maintain strong relationships with external stakeholders
• Provide guidance and support for the review and approval of study concepts and protocols

Medical Director

Medical Director

Director, Clinical Scientist

Director, Clinical Scientist

Associate Medical Director

Director of Protein Engineering

Senior Manager, Medical Writing

Director, Marketing Operations

Associate Director, Medical Affairs Operations

Senior Manager, Global Data Generation

Principal Statistical Analyst

Executive Director, HCP Marketing – Lung Lead

Director, Statistical Programming

Senior Manager, Regulatory Affairs

Associate Director, Data Generation