Director, Clinical Supply Chain IRT

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.

Location:Princeton NJ or Palo Alto CA ONSITE

Overview of Role:

We areseekinga highly motivated solutions-oriented Director Clinical Supply Chain IRT to lead the development implementation and continuous improvement of IRT standards across clinical development programs. This is a high-impact role for a top performer who thrives in a dynamic biotech environment canoperatestrategically and hands-on and is able to translate complex clinical operational and supply chain requirements into clear standards robust processes and effective system solutions.

The Director Clinical Supply Chain IRT will serve as the subject matter expert and process owner for IRT standards and related ways of working. The role will partner closely with Clinical Supply Chain Clinical Operations Quality IT external vendors and study teams to deliver fit-for-purpose IRT solutions that support efficient study start-up reliable execution compliant change management and scalable clinical supply operations.

Role and Responsibilities:

• Lead development and process improvement activities within and across teams including knowledge-sharing sessions training forums and targeted information sessions

• Provide expert consultancy to internal and external stakeholders on study-specific IRT solutions process development program strategy and practical options to meet evolvingprogramneeds

• Act as process owner for IRT processes and sub-processes ensuring theyremainclear compliant efficient and scalable

• Set the standard for excellence in IRT setup change management and cross-functional delivery while modelling the valuesbehaviors and performance expectationsrequiredin a dynamic biotech environment

• All other duties as assigned

Experience Education and Specialized Knowledge and Skills:

• Bachelors degree in life sciences supply chain pharmacy or a related discipline; advanced degree preferred

• Significant experience(10 years) in Clinical Supply Chain Clinical Operations IRT/RTSM or a closely related clinical development function within the pharmaceutical biotechnology or CRO environment

• Strong working knowledge of IRT/RTSM design testing UAT change control and study implementation processes

• Experience developing technical standards SOPs process documentation risk assessments and training materials

• Demonstrated ability tooperateeffectively in a fast-paced cross-functional and matrixed biotech environment

• Proven ability to influence stakeholders manage competing priorities and drive high-quality outcomes with minimal oversight

• Strategic thinker with strong operational execution capability

• Excellent written and verbal communication skills with the ability to simplify complex information for diverse audiences

• Strong process mindset with a focus on scalability compliance governance and continuous improvement

• High attention to detail and commitment to quality inspection readiness and documentation excellence

• Collaborative leadership style with the ability to build credibility across internal and external stakeholders

• Self-directed adaptable and comfortable working through ambiguity in a growing biotech environment

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.

Summit Therapeutics an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment hiring training or promotion or any other employment practices for reasons of race color religion gender national origin age sexual orientation marital or veteran status disability or any other legally protected status.