Director, Real-World Evidence (RWE)

Summit Therapeutics Sub•Princeton, NJ

4d•$192,000 - $237,000

About The Position

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: Summit Therapeutics is seeking an Director, Real-World Evidence (RWE), to join our mission of developing Ivonescimab, a novel and unique immunotherapy with the potential to help patients suffering from life-threatening cancers. The Director of RWE will lead initiatives to develop the RWE strategy and evidence generation initiatives at Summit Therapeutics. This position is responsible for the design, execution and dissemination of RWE studies and related research activities to support access, product differentiation, and lifecycle management. In addition, this role is accountable for acquisition and analyses of observational RWE, including claims, disease registry, labs and electronic health/medical records (EHR/EMR) data. The role requires a leader with deep expertise in observational research methodologies and study design. The ideal candidate will thrive in a fast-paced environment and be adept at collaborating with internal cross-functional teams and external stakeholders.

Requirements

Advanced degree (Masters, PharmD or PhD) in Epidemiology, Biostatistics, Data Science, Health Outcomes Research, Quantitative Methods, Clinical Informatics or related field
Minimum 7+ years relevant experience in healthcare industry with direct experience in clinical, observational or RWE data management, curation and analysis
Experience establishing and maintaining relationships with external vendors and organizations for RWD and RWE
Experience developing and implementing process and data standards
Demonstrated strong technical writing skills and oral presentation skills with a track-record of publishing in peer-reviewed journals and presenting at medical/scientific conferences
Ability to work under pressure with a high level of autonomy/leadership on research projects and collaborate with multiple partners in a matrixed environment

Nice To Haves

Previous experience in Oncology, preferably non-small cell lung cancer (NSCLC)
Demonstrate strong quantitative skills and methods expertise to generate rapid insights from real-world and observational data sources
Experience statistical analysis tools such as R and SAS, a plus
Knowledgeable of the external regulatory environment (FDA, EMA) for real-world evidence and maintains awareness of developments in epidemiology, research, and technology including AI

Responsibilities

Lead the development and execution of RWE projects to address evidence needs in line with medical affairs, HEOR and market access objectives and business needs
Collaborate internally and externally to address RWE needs and strategies
Formulate research questions, develop study protocols and design robust studies to generate impactful real-world evidence.
Conduct annual data gap analyses to identify key areas of evidence generation
Manage project budgets, ensuring efficient resource allocation, vendor management and timely delivery
Ensure data acquisition and transfers follow quality standards coordinating with key stakeholders to ensure data will satisfy analysis plans
Skill and experience identifying, designing and supporting or leading real-world evidence studies
Maintain knowledge and awareness of data sources to identify appropriate data sources for addressing questions of interest, recognizing the limitations and strengths of various design options and sources
Spearhead initiatives of advanced technologies like gen-AI, agentic AI and their applications to RWE
Develop and deliver presentations, manuscripts, scientific data packages or other communications
Assure highest standards of quality, compliance and management of all research activities