Director, External Supply Leader (DS / DP)

Job Description

Job Description

Location : US onsite (Princeton, NJ, Menlo Park CA, Miami, FL) or Oxford, UK

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.

Overview of Role :

Director, External Supply Leader (DS / DP) will support development of the strategy and lead / participate in the execution of Summit’s global supply chain plans for commercial product(s). This role is pivotal in ensuring the efficient and compliant delivery of high-quality pharmaceuticals to customers worldwide. The successful candidate will oversee the activities related to the external manufacture of drug substance and drug product batches for clinical and commercial programs in US and global markets, lead the strategic and tactical related aspects of Summit’s engagement with external manufacturers and operational partners from a business perspective, including managing day to day vendor relationships to further DS / DP batch production activities.

Roles and Responsibilities :

• Manage and oversee production at 3rd party / contract manufacturing organizations (CMO’s) from a business and operational perspective.
• Responsibilities include, but not limited to ensuring quality and compliance, managing the DS / DP CMO’s, lead forecasting discussions and alignment with forecasting terms in contracts, ensuring schedule adherence, and all activities related to business / tactical aspects (quotes, PO’s, invoices etc.) of ensuring a DS / DP batch is manufactured on-time to the schedule by the planning team
• Collaborate with internal teams to ensure all production-related goals are met.
• Act as the main business point of contact for ongoing supply related activities with drug substance and drug product vendors to ensure on time delivery of batches for forward processing to the next manufacturing node.
• Support the implementation of the global supply chain strategy to further clinical and commercial goals, including product availability, cost optimization, and customer satisfaction.
• Collaborate with CMC / Tech Ops, Procurement, Commercial, Finance, QA and operational teams, ensuring high levels of compliance, performance, and alignment with business objectives.
• Drive continuous improvement initiatives in collaboration with wider teams to enhance supply chain efficiency, sustainability, and resilience in the DS / DP domain.
• Ensure the forecasted demand is aligned with production capabilities, optimizing inventory levels and minimizing excess or shortage at DS / DP vendors.
• Ensure that the DS / DP CMO’s are executing to the operational forecasts and plans as directed by the cross functional teams.
• Lead or participate in quarterly or bi-annual business review meetings with the assigned vendors, ensuring appropriate KPI’s being agreed to with the CMO’s and adherence to the same.
• As needed, support long term strategic activities for supplier selection, negotiation, operations and performance management to ensure that partnerships align with organizational goals.
• Manage any third-party manufacturers (CMOs), as assigned and logistics providers to ensure the highest standards and adherence to timelines.
• Proactively identify and resolve issues within the supply chain that could affect the delivery of commercial products.
• Lead efforts to streamline processes, reduce lead times, and improve cost-efficiency without compromising product quality.
• Ensure that all commercial supply chain activities comply with relevant regulatory requirements, including cGMP (current Good Manufacturing Practices), GDP (Good Distribution Practices), and country-specific regulations.
• Stay current with industry trends and evolving regulatory standards to ensure compliance and alignment with best practices.
• All other duties as assigned.

Experience, Education and Specialized Knowledge and Skills :

The pay range for this role is $184,000-$230,000 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 Summit’s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit.