Senior Manager, Procurement & Vendor Management (R&D Clinical)
About The Position
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 eg osimertinibHARMONi 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 NSCLCHARMONi 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 expressionIvonescimab 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 Senior Manager Procurement & Vendor Management R&D Clinical will lead sourcing strategy contracting and governance activities across Summits global clinical research and development organization This individual will report into the HeadSenior Director of Procurement and Vendor Management The successful incumbent will be responsible for all phases of clinical study execution such as CROs central labs and other specialty clinical suppliers across R&D The role ensures that vendors deliver high quality compliant and cost effective services aligned with Summits clinical and operational goals Moving forward this role could expand to take on other additional responsibilities across R&D and in Procurement
Requirements
- Minimum BABS degree or relevant graduate degree preferred
- Minimum of 8 years of experience in a ProcurementVendor Management environment in a pharmaceutical CRO biotech company or worked in a clinical R&D operations setting with a CROSponsor company
- Good understanding of the drug development R&D process is important
- In depth understanding of clinical trial related execution of large global studies including CROs central labs imaging drug supply CMC vendors and ancillary suppliers
- Strong knowledge of GCP ICH and regulatory expectations governing outsourced clinical activities
- Demonstrated ability to multi task prioritize and independently solve problems in a rapidly changing environment
- Proficient user of standard MS Office suite eg Word Excel experience using electronic document management systems eg Veeva Vault etc and document review tools desirable
- Strong computer and database skills and experience with procurement or contract management systems eg Ariba Coupa etc
- Attention to detail accuracy and confidentiality with clear and concise oral and written communication skills
- Excellent organizational skills
- Critical thinking problem solving ability to work independently
- Must be able to effectively multi task and manage time sensitive and highly confidential documents
- Demonstrated ability to collaborate cross functionally manage competing priorities and operate in a fast paced high growth organization
Nice To Haves
- Oncology experience preferred
- Oncology or rare disease experience is desirable
Responsibilities
- Develop and execute R&D category sourcing strategies across Clinical Operations Medical Affairs and related R&D categories with a focus on driving quality compliance and cost savings
- Provide input and feedback to strategic procurement processes and best practices
- Manage the end to end procurement for clinical services including RFIRFP management bid evaluation supplier selection onboarding risk assessment and MSASOW review
- Negotiate contracts rate cards and pricing terms; manage CROclinical budgets seeking cost efficiencies
- Collaborate effectively with business stakeholders in Clinical Operations R&D Legal and Finance to forecast vendor needs plan budgets and align as needed to review amend negotiate and complete contracts
- Serve as primary point of contact for suppliers build strong relationship with suppliers and facilitate vendor governance process including quarterly business review meetings with key suppliers as appropriate based on vendor segmentation
- Establish vendor performance governance by reviewing score cards quality incidents KPIs SLAs and risksissues escalation
- Monitor and evaluate supplier performance compliance and cost effectiveness while identifying improvement opportunities and implementing corrective actions as needed
- Help maintain contract trackers supplier databases and documentation for various projects and enter contract requests into the Summit legal portal
- Assist and work with senior management on continuous improvement of procurement processes automation projects and other strategic projects
- All other duties as assigned
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Industry
Chemical Manufacturing
