Mgr/Sr. Mgr, Clinical Trial Supp.(Contractor)

About KalVista Pharmaceuticals, Inc.

KalVista Pharmaceuticals, Inc. (http://www.kalvista.com) is focused on the discovery, development, and commercialization of novel, oral therapies for diseases with significant unmet need, with an initial focus on hereditary angioedema (HAE). Listed on the Nasdaq Global Market, our headquarters is located in Cambridge, MA with additional offices and laboratories in Salisbury, UK; Zug, Switzerland; and Salt Lake City, UT.

The company has an R&D team with an established track record in the pharmaceutical development of small molecule protease inhibitors, world-leading expertise in the role of plasma kallikrein in disease, and a management team with the capability to bring small molecules through the clinic to commercialization.

KalVista seeks a Manger/Sr. Manager, Clinical Trials Supplies (Contractor), who is critical to the organization's mission as it prepares to commercialize sebetralstat, a novel, oral plasma kallikrein inhibitor. KalVista recently reported positive results from the KONFIDENT Phase 3 study which demonstrated that sebetralstat met all primary and secondary endpoints for the on-demand treatment of HAE attacks and the safety profile was comparable to placebo. The Company plans to submit a new drug application to the U.S. Food and Drug Administration (FDA) in the first half of 2024 and expects to file for approval in Europe and Japan later in 2024. We also continue to move development forward with an orally disintegrating tablet (ODT) version of sebetralstat, as well as a pediatric indication. 

About the Role:

The Manager/Sr. Manager, Clinical Trials Supplies (Contractor) will provide technical and strategic input regarding the clinical supply of Investigational Medicinal Product (IMP) to the KalVista clinical development program. In this critical role, you will work with external contract clinical supplies organizations (CTSOs) to supply IMP in a timely and cost-efficient manner.  

Responsibilities:

• Develop clinical supply strategy in conjunction with Clinical Team
• Work with the Clinical and Regulatory Teams to ensure that the label texts for each territory involved in a clinical trial meet requirement

• Work with the Clinical and CMC Teams to ensure that the primary and secondary packaging are suitable for both the clinical trial design and the local climate 
• Lead the development and implementation of Interactive Response Technology (IRT) systems
• Lead the selection of and work with external clinical trials supply organizations (CTSOs) and consultants to support KalVista clinical development program
• Ensure that appropriate quality standards are maintained
• Provide input to project teams on all aspects associated with packaging, labelling, release and distribution of IMP
• Manage CTSOs to provide IMP on time and to budget in support of KalVista clinical development program
• Produce, review and approve User Requirement Specification (URS) and User Acceptance Testing (UAT) documentation for IRT systems for randomization and allocation of IMP to clinical trials subjects
• Manage UAT on IRT systems
• Work in accordance with KalVista’s SOPs and Policies  

Requirements:

• Pharmacy, chemistry or equivalent background. Alternatively, experience in Supply Chain
• Trained in GMP (GCP)
• Demonstrated experience in global clinical trial supplies, ideally including the EU
• Demonstrated experience managing external contract packaging, labelling and distribution organizations 
• Demonstrated experience of the setup and use of IRT systems to control IMP assignment to patients and for supply-chain management
• Experience supporting Early Access Programs (EAP) a plus
• Bachelor’s Degree require.
• Hybrid Role – 2 days per week in office