Executive Director, Analytical Sciences

Location: Princeton NJ (on-site)

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.

Role and 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.

Experience Education and Specialized Knowledge and Skills:

• 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

The pay range for this role is $260000-$280000 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 at to obtain prior written authorization before referring any candidates to Summit.