Associate Director, Clinical Supply Management

Associate Director, Clinical Supply Management
Princeton, NJ (US) and Palo Alto, CA (US)

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.

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.

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.

Office Location : Princeton, NJ or Palo Alto, CA ONSITE
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 escal…

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

This is the pay for this position

Pay Transparency

$174,000 - $204,000 USD

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 View email address on healthcarejobsite.com 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.

Voluntary Self-Identification
For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Summit Therapeutics's Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

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