Associate Director, Data Generation

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. At Summit we believe in building a team of world class professionals who are passionate about this mission and it is our people who drive this mission to reality. Summits core values include integrity passion for excellence purposeful urgency collaboration and our commitment to people. Our employees are truly the heart and soul of our culture and they are invaluable in shaping our journey toward excellence.

Summits team is inspired to touch and help change lives through Summits clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies including:

Non-small Cell Lung Cancer (NSCLC)

• HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.

• HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.

• HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.

Colorectal Cancer (CRC)

• HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.

Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than Chinas National Medical Products Administration (NMPA). Summit is headquartered in Miami Florida and has additional offices in California New Jersey the UK and Ireland.

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 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.

Role and 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

Experience Education and Specialized Knowledge and Skills:

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

The pay range for this role is $174000-$204000 annually. Actual compensation packages are based on several factors that are unique to each candidate including but not limited to skill set depth of experience certifications and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus stock benefits and/or other applicable variable compensation.

Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summits Talent Acquisition team atto obtain prior written authorization before referring any candidates to Summit.