Executive Director, Analytical Sciences

Summit Therapeutics Sub•Princeton, NJ

7d•$260,000 - $280,000•Onsite

About The Position

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 Executive Director, Analytical Sciences will provide strategic and operational leadership for all analytical activities supporting the development, registration, and commercialization of the Companys lead bispecific antibody product. With the first Biologics License Application (BLA) already submitted, this role is critical to ensuring regulatory compliance, product control, and lifecycle readiness as the organization transitions from late-stage development into commercial supply. The successful candidate will be accountable for the end-to-end analytical control strategy, including method development, qualification, transfer, and oversight of GMP release and stability testing executed through a virtual network of CDMOs and partner laboratories. This individual will act as a key CMC leader and regulatory partner, interfacing closely with Quality, Manufacturing, Regulatory Affairs, and external collaborators.

Requirements

PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field (MS with extensive relevant experience considered)
Experience 15+ years of progressive experience in analytical sciences within the biopharmaceutical industry
Demonstrated leadership in late-stage development and commercial biologics
Direct experience supporting BLA/MAA submissions and approvals
Strong expertise in monoclonal and/or bispecific antibodies
Proven success operating within virtual or highly outsourced CMC models
Technical Expertise Deep knowledge of: Physicochemical and functional characterization of biologics Potency, binding, and cell-based assays Stability programs and comparability strategies
Strong understanding of GMP, ICH, FDA, EMA, and global regulatory requirements
Experience managing analytical aspects of process changes, scale-up, and post-approval lifecycle management
Leadership & Competencies Strategic thinker with a commercial mindset Comfortable operating in ambiguity and fast-paced, resource-lean environments Strong external partner and stakeholder management skills Excellent written and verbal communication, including regulatory writing Hands-on leader capable of balancing strategic oversight with technical depth

Responsibilities

Analytical Strategy & Product Control Own and continuously evolve the global analytical control strategy for clinical and commercial drug substance and drug product.
Ensure analytical readiness to support BLA review, responses to regulatory questions, inspections, and post-approval commitments.
Define analytical lifecycle management strategies aligned with ICH Q2/Q6/Q12 and global regulatory expectations.
Method Development, Qualification & Transfer Provide oversight and scientific leadership for: Method development and optimization Method qualification and validation Method transfer to internal and external laboratories Ensure analytical methods are phase-appropriate, robust, stability-indicating, and fit for commercial use.
Troubleshoot complex analytical issues related to bispecific antibodies (e.g., heterogeneity, potency, binding, impurities).
GMP Release & Stability Oversight Accountable for all drug substance and drug product release and stability testing conducted at external CDMOs and partner labs.
Ensure compliance with cGMP, data integrity, and regulatory filing requirements.
Review and approve analytical protocols, reports, deviations, OOS/OOT investigations, and change controls.
CDMO & Partner Management Lead analytical governance across a virtual network of CDMOs, contract labs, and development partners.
Set expectations, KPIs, and quality standards for external analytical execution.
Serve as the primary analytical escalation point for CDMO performance, compliance, and technical issues.
Regulatory Support Act as the analytical subject-matter expert for global regulatory interactions.
Author, review, and approve analytical sections of: BLAs, MAAs, and IND/IMPD amendments Regulatory responses and briefing packages Support regulatory inspections, audits, and health authority meetings.
Cross-Functional Leadership Partner closely with Process Development, Manufacturing, Quality, Regulatory Affairs, and Supply Chain.
Contribute to overall CMC strategy, risk management, and commercialization planning.
Build scalable analytical capabilities aligned with future pipeline expansion.