Senior Manager, Procurement & Vendor Management (CMC Supply Chain)

About Summit:

Ivonescimab known as SMT112 is a novel potential first-in-class investigational

bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF.

Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC) with three active Phase III trials:

• HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g. osimertinib).

• HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.

• HARMONi-7 is a Phase III clinical trial which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression.

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summits license territories including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024. Ivonescimab was granted Fast Track designation by the US Food & Drug Administration (FDA) for the HARMONi clinical trial setting.

Overview of Role:

The Sr. Manager Procurement & Vendor Management (Chemistry Manufacturing and Controls CMC (CMC) / Supply Chain) will be responsible for sourcing contracting and managing external suppliers of raw materials chemicals and drug substances used in the manufacturing and Supply Chain operations. This role plays a critical role in ensuring reliable and cost-effective supply of materials while ensuring compliance with regulatory standards (GMP ICH). The successful incumbent will be responsible for strategic outsourcing contract negotiation budget management quality oversight driving innovation within the supply chain and supplier relationship management activities across the biopharmaceutical value chain.

Reporting to the Head/Senior Director of Procurement and Vendor Management the position will drive category strategy risk management and continuous improvement initiatives for Summits CMC and supply chain network. Moving forward this role could expand to take on other additional responsibilities in Procurement including Commercial Market Access and other non-R&D related areas.

Role and Responsibilities:

• Develop and execute category sourcing strategies for CMC materials and supply chain focusing on quality reliability value and cost optimization.
• Identify qualify and onboard suppliers of chemicals raw materials and intermediates assessing their capabilities quality systems and compliance within conjunction with CMC Quality and Technical Operations team.
• Lead end-to-end procurement activities including RFI/RFP process vendor selection & qualification and MSA/SOW review
• Partner with Contract Development and Manufacturing Organizations (CDMOs) to ensure capacity alignment operational readiness and performance to supply agreements.
• Build strong relationships with external suppliers and develop a preferred vendor strategy/list
• Negotiate contracts rate cards and pricing terms; manage CDMOs and other suppliers seeking cost efficiencies through regular business reviews performance metrics and continuous improvement discussions.
• Identify and mitigate potential risks associated with the CMC supply chain including supplier disruptions quality issues and regulatory changes.
• Collaborate effectively with business stakeholders in CMC Legal and Finance as needed to forecast spend track budgets and review amend and negotiate contracts while ensuring alignment with Summits priorities.
• Facilitate vendor governance process by instituting quarterly business review meetings with key suppliers as appropriate based on vendor segmentation
• Monitor vendor performance by reviewing score cards quality incidents KPIs SLAs and risks/issues
• Help maintain contract trackers for various projects and enter contract requests into the Summit legal portal
• Assist and work with senior management to standardize procurement processes tools and support special projects
• All other duties as assigned

Experience Education and Specialized Knowledge and Skills:

• Minimum BA/BS degree in Life Sciences/Pharmacy Engineering Supply Chain Management or relevant graduate degree preferred
• Minimum of 8 years of experience in Procurement Sourcing or Vendor Management within a regulated pharmaceutical CDMO / biotech environment.
• Deep knowledge of outsourcing raw materials drug substances and chemicals used in the CMC and supply chain processes
• Proven success managing external manufacturing partners and negotiating complex technical and commercial agreements
• Demonstrated ability to analyze market trends supplier capabilities and total cost of ownership to drive strategic decisions.
• Demonstrated ability to multi-task prioritize and independently solve problems in a rapidly changing environment
• Proficient user of standard MS Office suite (e.g. Word Excel) with ERP/procurement systems knowledge (SAP Ariba Coupa etc.)
• Strong computer and database skills and Excellent organizational skills
• Ability to communicate effectively and articulate complex ideas in an easily understandable way with attention to detail accuracy and confidentiality
• Clear and concise oral and written communication skills
• Critical thinking problem solving ability to work both collaboratively and independently
• Must be able to effectively multi-task in a fast-paced environment and manage time-sensitive and highly confidential documents

The pay range for this role is $155000-$185000 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 Summits Talent Acquisition team atto obtain prior written authorization before referring any candidates to Summit.