Associate Director, Clinical Supply Management (UKEU)

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: Oxford UK or Zug Switzerland or Dublin Ireland

Overview of Role:

The Associate Director Clinical Supply Management supports the Senior Director in leading the full scope of global clinical supply chain responsibilities. The role translates functional strategy into disciplined execution across demand and supply planning inventory management packaging and labelling distribution returns and destruction cross-border compliance and GxP operations. Acting as a key delegate for the Senior Director the (Associate) Director provides a layer of management for direct reports establishes clear priorities and performance expectations develops team capability and drives operational excellence through standardized processes meaningful metrics proactive risk management and continuous improvement. The role partners closely with Clinical Operations Commercial CMC Quality Regulatory Finance Legal Procurement Medical Affairs and Program Management and oversees external partners including Contract Development and Manufacturing Organizations (CDMOs) IXRS providers and specialist service providers.

Role and Responsibilities:

• Supports the Senior Director in developing functional strategy operating plans budgets governance and performance objectives across global clinical supply chain activities
• Leads day-to-day execution for new and ongoing studies and products ensuring robust forecasting supply planning schedule adherence inventory optimization global logistics and sustained GxP compliance
• Serves as a delegate for the Senior Director in cross-functional forums governance meetings supplier reviews and issue escalation providing clear recommendations and ensuring timely follow-through.
• Manages and develops direct reports translating functional priorities into individual objectives balancing workloads coaching performance supporting career development and ensuring appropriate succession and capability plans.
• Creates an effective management layer by coordinating team activities reinforcing accountability removing operational barriers and escalating material risks or decisions to the Senior Director.
• Overseeing the Clinical Supply Management (CSM) team the Associate Director interprets complex clinical protocols development plans and commercial demand forecasts working with CMC and internal and external partners to develop packaging labelling supply and resupply strategies timelines and plans.
• Supports the accountability of CSM team to oversee packaging labelling release distribution resupply returns reconciliation and destruction activities across global locations
• Develops and maintains supply project budgets resource plans and integrated schedules monitors performance and proactively resolves variances
• Manages CDMO and service-provider activities from RFP and contracting support through routine operations troubleshooting invoicing and performance management using defined KPIs and service expectations
• Supports IXRS selection design set-up User Acceptance Testing (UAT) implementation and ongoing operational performance as required by IRT Management Team.
• Drives operational excellence by defining standard work governance routines KPIs and dashboards; uses trend and root-cause analysis to improve service quality cost compliance and team productivity
• Leads continuous-improvement initiatives that streamline and harmonize processes strengthen inspection readiness and embed sustainable ways of working
• Supports regulatory submissions audits and inspections and ensures timely management of SOPs change controls deviations investigations and CAPAs within the function
• Provides continuity of leadership and performs other responsibilities within the function as assigned

Experience Education and Specialized Knowledge and Skills:

• BSc MSc engineering or pharmacy degree or equivalent with a minimum of 8 years of progressive supply chain experience in a pharmaceutical biotechnology or contract development and manufacturing organization (CDMO) environment
• Demonstrated success leading complex international clinical studies and product supply chains with broad knowledge of regulatory and GMP requirements for IMP and commercial product packaging and supply
• Prior people-management experience including setting objectives coaching performance developing talent delegating effectively and managing through others
• Demonstrated ability to translate strategy into executable priorities operating rhythms metrics and measurable team outcomes
• Strong operational-excellence and continuous-improvement capability including process standardization KPI management root-cause analysis and sustainable implementation of improvements
• Solid understanding of IXRS design specifications set-up and UAT together with proficiency in clinical supply planning and forecasting tools
• Strong project budget risk and resource-management skills with the ability to manage multiple priorities while maintaining high-quality results
• Expertise in outsourcing supplier governance negotiation and performance management
• Experience building scaling or improving end-to-end product supply chains and associated business processes
• Ability to operate as a trusted deputy to the Director exercise sound judgement within delegated authority and escalate issues with clear options and recommendations
• Confident communicator able to influence all levels of the organization and build effective relationships with global colleagues customers and suppliers
• Able to work independently with complex global problems while fostering inclusion collaboration accountability and effective team leadership
• Agile and resilient in a dynamic organization where priorities may change rapidly
• Knowledge of the drug development process and applicable FDA EMA and PMDA expectations including GMP GCP Annex 13 and relevant clinical trial requirements
• Technically proficient with industry-standard systems and tools and able to use technology data and industry trends to improve efficiency and decision-making
• Knowledgeable of and compliant with SOPs change controls deviations investigations and CAPAs

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.