Associate Director, Data Generation

Summit Therapeutics Sub•Palo Alto, CA

21h•$174,000 - $204,000

About The Position

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 will support the management of all non-sponsored research collaborations, including investigator-sponsored trials (ISTs), global Cooperative Group trials, non-sponsored registrational trials, as well as real-world evidence studies, ensuring alignment with Summits overall clinical and scientific strategic objectives. The Associate Director will collaborate cross-functionally with medical, clinical, regulatory, CMC/drug supply, biostatistics, PV/safety, and the research teams to generate high-quality evidence that informs product value, enhances scientific understanding, and supports publication and regulatory strategies. The ideal candidate will bring a strong background in oncology research, project management, and stakeholder engagement, with demonstrated experience managing complex research programs in a fast-paced, innovative environment.

Requirements

Advanced degree (PhD or equivalent) in life sciences or related field highly preferred, candidates with a masters degree in life sciences and extensive relevant experience will be considered.
Minimum of 7+ years of experience in a relevant role within the pharmaceutical industry required; a strong focus in oncology preferred.
Experience working in clinical trial management, research management, and/or Medical Affairs research programs; Familiarly with clinical research terminology required
Experience with IST management software platforms (e.g. iEnvision ISR platform) and tools and fair market value analysis (e.g. IQVIA GrantPlan for Investigators).
Experience producing and analyzing metrics/reports
Strong clinical/scientific acumen required including the ability to interpret, analyze, organize, and communicate scientific data.
Strong interpersonal and communication skills with the ability to work effectively in a cross-functional, matrixed organization.
Non-Sponsored Research/Investigator Sponsored Trial (IST) management experience preferred
Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools.
Strong computer and database skills
High attention to detail, strong analytical, and organizational skills
Critical thinking, problem solving, and ability to work independently.
Must be able to effectively multi-task and manage time-sensitive and highly confidential documents.
Work in a fast-paced, demanding, and collaborative environment.

Nice To Haves

Experience working with KOLs, academic institutions, and community physicians is a plus.

Responsibilities

Independently oversee all operational aspects of non-sponsored research studies, delivering comprehensive end-to-end management. Responsibilities include planning discussions, protocol development, site coordination, document management, contract execution, fair market value evaluations, drug shipments, and oversight of project budgets and execution to ensure timelines and team goals are met.
Responsible for identifying key data gaps and developing strategies to address them through innovative research approaches. This includes proactively engaging with both internal and external stakeholders to assess emerging scientific trends and opportunities that may impact the Companys research program. This role requires a forward-thinking mindset to anticipate future evidence needs and to ensure that data generation activities are both comprehensive and strategically aligned with clinical, regulatory and commercial objectives.
Develop metrics and dashboards to monitor the progress and impact of data generation initiatives, providing regular updates to leadership and key stakeholders.
Oversee the development and organization of the content, summaries and outcomes from the IST Scientific Review Committee meetings 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 vendor to oversee the development and optimization of the IST platform system
Work in conjunction with the finance team to conduct Fair Market Value evaluations for approved non-sponsored research protocols, track achievement of milestones that trigger payment, and perform budget reconciliation as well as forecast future milestone
Partner with cross-function teams, including clinical, regulatory, PV/safety, biostatistics, and CMC to ensure effective management of the IST program
Manage all Non-Sponsored Research trial contracts working closely with legal
Remain abreast of new operations standards, platforms and practices and champion best practice adoption by Summit GMA.
Foster and maintain strong relationships with external stakeholders, including key opinion leaders (KOLs), investigators, and global cooperative research groups, to facilitate successful collaborations and ensure timely and effective execution of research initiatives.
Provide guidance and support for the review and approval of study concepts and protocols, ensuring compliance with regulatory and ethical standards throughout all phases of project development.
Functional expertise to initiate, author, or contribute to SOP development, implementation, and training, participate in process improvement exercises to drive operational excellence
All other duties as assigned