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.
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 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.
Location: Princeton, NJ ONSITE
Overview of Role:
We are seeking a 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, can operate strategically 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 evolving program needs
- Act as process owner for IRT processes and sub-processes, ensuring they remain clear, compliant, efficient, and scalable
- Set the standard for excellence in IRT setup, change management, and cross-functional delivery, while modelling the values, behaviors, and performance expectations required in a dynamic biotech environment
- All other duties as assigned
Experience, Education and Specialized Knowledge and Skills:
- Bachelor’s 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 to operate effectively 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
This is the pay for this position
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 Summit’s Talent Acquisition team at [email protected] to obtain prior written authorization before referring any candidates to Summit.
Summit Therapeutics Inc. is 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.
Skills Required
- Bachelor's degree in life sciences, supply chain, pharmacy, or related discipline
- 10+ years experience in Clinical Supply Chain, Clinical Operations, IRT/RTSM, or related clinical development function
- 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
- Proven ability to influence stakeholders, manage competing priorities, and deliver high-quality outcomes with minimal oversight
- Excellent written and verbal communication skills, with ability to simplify complex information for diverse audiences
- High attention to detail and commitment to quality, inspection readiness, and documentation excellence
- Collaborative leadership style and ability to build credibility across internal and external stakeholders
- Ability to operate effectively in a fast-paced, cross-functional, matrixed biotech environment
- Advanced degree (MS, PharmD, PhD)
What We Do
Summit Mission Statement: To build a viable, long-lasting health care organization that assumes full responsibility for designing, developing, trial execution and enrollment, regulatory submission and approval, as well as successful commercialization of patient, physician, caregiver, and societal-friendly medicinal therapy intended to: improve quality of life, increase potential duration of life, and resolve serious medical healthcare needs. To identify and control promising product candidates based on exceptional scientific development and administrational expertise, develop our products in a rapid, cost-efficient manner, and to engage commercialization and/or development partners when appropriate. We accomplish this by building a team of world class professional scientists and business administrators that apply their experience and knowledge to this mission. Team Summit exists to pose, strategize, and execute a path forward in medicinal therapeutic health care that places Summit in a well-deserved, top market share, leadership position. Team Summit assumes full responsibility for stimulating continuous expansion of knowledge, ability, capability, and well-being for all involved stakeholders and highly-valued shareholders. Summit was founded in 2003 and our shares are listed on the Nasdaq Global Market (symbol ‘SMMT’). We are headquartered in Miami, Florida, and we have additional offices in Palo Alto, California, Princeton, New Jersey, Oxford, UK, and Dublin, Ireland.
