Associate Director, Data Generation
Summit Therapeutics, Inc., Palo Alto, California, United States
Overview
About Summit
Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. Summit believes in building a team of world class professionals who are passionate about this mission, and our people drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and a commitment to people. Our employees are the heart and soul of our culture and are invaluable in shaping our journey toward excellence. Overview Of Role The Associate Director, Global Data Generation will play a critical role in driving the strategy, planning, and execution of data generation initiatives to support development and commercialization. This position supports management of all non-sponsored research collaborations, including investigator-sponsored trials (ISTs), global Cooperative Group trials, non-sponsored registrational trials, and real-world evidence studies, ensuring alignment with Summit’s clinical and scientific objectives. The Associate Director will collaborate cross-functionally with medical, clinical, regulatory, CMC/drug supply, biostatistics, PV/safety, and research teams to generate high-quality evidence that informs product value, enhances scientific understanding, and supports publication and regulatory strategies. The ideal candidate will have a strong background in oncology research, project management, and stakeholder engagement, with experience managing complex research programs in a fast-paced, innovative environment.
Role And Responsibilities
Independently oversee all operational aspects of non-sponsored research studies, delivering comprehensive end-to-end management (planning discussions, protocol development, site coordination, document management, contract execution, fair market value evaluations, drug shipments, and oversight of project budgets and timelines). Identify key data gaps and develop strategies to address them through innovative research approaches, engaging internal and external stakeholders to assess emerging scientific trends and opportunities. Anticipate future evidence needs and ensure data generation activities are comprehensive and aligned with clinical, regulatory, and commercial objectives. Develop metrics and dashboards to monitor progress and impact of data generation initiatives, providing regular updates to leadership and stakeholders. Oversee the IST Scientific Review Committee content, summaries, and outcomes as a member of the cross-functional committee. Liaise with study sites and the CMC/IMP team to manage and forecast drug supply requirements for the program. Work with external vendors to oversee the development and optimization of the IST platform system. Coordinate with the finance team to conduct Fair Market Value evaluations for approved ISTs, track milestone payments, perform budget reconciliation, and forecast future milestones. Partner with cross-functional teams (clinical, regulatory, PV/safety, biostatistics, CMC) to ensure effective IST program management. Manage all Non-Sponsored Research trial contracts in collaboration with legal. Stay current with operations standards, platforms, and practices; champion best practices within Summit GMA. Foster relationships with external stakeholders, including key opinion leaders (KOLs), investigators, and global cooperative groups, to enable successful collaborations and timely execution of research initiatives. Provide guidance for review and approval of study concepts and protocols, ensuring regulatory and ethical compliance throughout all phases. Initiate, author, or contribute to SOP development, implementation, and training; participate in process improvement to drive operational excellence. All other duties as assigned.
Experience, Education And Specialized Knowledge And Skills
Advanced degree (PhD or equivalent) in life sciences or related field highly preferred; candidates with a master’s degree and extensive relevant experience will be considered. Minimum of 7+ years of experience in a relevant pharmaceutical role; oncology focus preferred. Experience in clinical trial management, research management, and/or Medical Affairs research programs; familiarity with clinical research terminology is required. Experience with IST management platforms (e.g., iEnvision ISR) and fair market value analysis tools (e.g., IQVIA GrantPlan). Experience producing and analyzing metrics/reports; strong clinical/scientific acumen for interpreting data. Strong interpersonal and communication skills for effective cross-functional collaboration. Experience working with KOLs, academic institutions, and community physicians is a plus. IST management experience preferred; proficient in MS Office, electronic document management systems, and document review tools; strong computer and database skills. High attention to detail, strong analytical and organizational skills; critical thinking and problem-solving ability; ability to work independently and multi-task in a fast-paced environment. Must be able to manage time-sensitive and confidential documents.
The pay range for this role is $174,000-$204,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including skill set, depth of experience, certifications, and location. The total compensation package may include bonus, stock, benefits, and other variable compensation. Summit does not accept referrals from employment businesses and/or employment agencies. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at recruiting@smmttx.com for prior written authorization before referring candidates.
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About Summit
Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. Summit believes in building a team of world class professionals who are passionate about this mission, and our people drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and a commitment to people. Our employees are the heart and soul of our culture and are invaluable in shaping our journey toward excellence. Overview Of Role The Associate Director, Global Data Generation will play a critical role in driving the strategy, planning, and execution of data generation initiatives to support development and commercialization. This position supports management of all non-sponsored research collaborations, including investigator-sponsored trials (ISTs), global Cooperative Group trials, non-sponsored registrational trials, and real-world evidence studies, ensuring alignment with Summit’s clinical and scientific objectives. The Associate Director will collaborate cross-functionally with medical, clinical, regulatory, CMC/drug supply, biostatistics, PV/safety, and research teams to generate high-quality evidence that informs product value, enhances scientific understanding, and supports publication and regulatory strategies. The ideal candidate will have a strong background in oncology research, project management, and stakeholder engagement, with experience managing complex research programs in a fast-paced, innovative environment.
Role And Responsibilities
Independently oversee all operational aspects of non-sponsored research studies, delivering comprehensive end-to-end management (planning discussions, protocol development, site coordination, document management, contract execution, fair market value evaluations, drug shipments, and oversight of project budgets and timelines). Identify key data gaps and develop strategies to address them through innovative research approaches, engaging internal and external stakeholders to assess emerging scientific trends and opportunities. Anticipate future evidence needs and ensure data generation activities are comprehensive and aligned with clinical, regulatory, and commercial objectives. Develop metrics and dashboards to monitor progress and impact of data generation initiatives, providing regular updates to leadership and stakeholders. Oversee the IST Scientific Review Committee content, summaries, and outcomes as a member of the cross-functional committee. Liaise with study sites and the CMC/IMP team to manage and forecast drug supply requirements for the program. Work with external vendors to oversee the development and optimization of the IST platform system. Coordinate with the finance team to conduct Fair Market Value evaluations for approved ISTs, track milestone payments, perform budget reconciliation, and forecast future milestones. Partner with cross-functional teams (clinical, regulatory, PV/safety, biostatistics, CMC) to ensure effective IST program management. Manage all Non-Sponsored Research trial contracts in collaboration with legal. Stay current with operations standards, platforms, and practices; champion best practices within Summit GMA. Foster relationships with external stakeholders, including key opinion leaders (KOLs), investigators, and global cooperative groups, to enable successful collaborations and timely execution of research initiatives. Provide guidance for review and approval of study concepts and protocols, ensuring regulatory and ethical compliance throughout all phases. Initiate, author, or contribute to SOP development, implementation, and training; participate in process improvement to drive operational excellence. All other duties as assigned.
Experience, Education And Specialized Knowledge And Skills
Advanced degree (PhD or equivalent) in life sciences or related field highly preferred; candidates with a master’s degree and extensive relevant experience will be considered. Minimum of 7+ years of experience in a relevant pharmaceutical role; oncology focus preferred. Experience in clinical trial management, research management, and/or Medical Affairs research programs; familiarity with clinical research terminology is required. Experience with IST management platforms (e.g., iEnvision ISR) and fair market value analysis tools (e.g., IQVIA GrantPlan). Experience producing and analyzing metrics/reports; strong clinical/scientific acumen for interpreting data. Strong interpersonal and communication skills for effective cross-functional collaboration. Experience working with KOLs, academic institutions, and community physicians is a plus. IST management experience preferred; proficient in MS Office, electronic document management systems, and document review tools; strong computer and database skills. High attention to detail, strong analytical and organizational skills; critical thinking and problem-solving ability; ability to work independently and multi-task in a fast-paced environment. Must be able to manage time-sensitive and confidential documents.
The pay range for this role is $174,000-$204,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including skill set, depth of experience, certifications, and location. The total compensation package may include bonus, stock, benefits, and other variable compensation. Summit does not accept referrals from employment businesses and/or employment agencies. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at recruiting@smmttx.com for prior written authorization before referring candidates.
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