Associate Director, Analytical Development & CMC Statistics

Associate Director, Analytical Development & CMC Statistics

Princeton, NJ

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. Summit’s 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.

Summit’s team is inspired to touch and help change lives through Summit’s 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.

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 China’s 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 of Analytical Development and CMC Statistics will provide technical and statistical leadership for analytical development, method validation, method transfer, comparability, stability, specifications, and lifecycle management activities supporting biologic drug substance and drug product programs. This role will sit within the CMC Analytical Sciences organization and will partner closely with Analytical, MSAT, Quality, Regulatory Affairs, Supply Chain, and external CDMOs/CROs to ensure that analytical strategies, statistical approaches, and data packages are scientifically robust, phase-appropriate, compliant, and suitable for global regulatory submissions and commercial readiness.

The successful candidate will combine hands-on experience in biologics analytical development with strong statistical expertise, including method validation statistics, stability and shelf-life modeling, specification setting, comparability assessments, assay lifecycle monitoring, and statistical support for CMC investigations. This individual will be expected to translate complex analytical datasets into clear conclusions, support risk-based decision-making, and contribute directly to IND/IMPD, BLA/MAA, post-approval, and health authority response activities.

Role and Responsibilities:

• Provide scientific and technical leadership for analytical method development, qualification, validation, transfer, troubleshooting, and lifecycle management for biologic drug substance and drug product programs.
• Support phase-appropriate analytical strategies for release, stability, characterization, comparability, potency, binding, impurity, and residual testing.
• Review and interpret analytical data from CDMOs, CROs, and partner laboratories to ensure methods are robust, fit for purpose, and aligned with regulatory expectations.
• Contribute to analytical control strategy development, including critical quality attribute assessment, method performance monitoring, and product quality trend evaluation.
• Lead statistical planning, analysis, and interpretation for analytical method validation, method transfer, comparability, stability,…