Medical Operations Coordinator

Job Description

Job Description

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 Medical Operations Coordinator which 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.

About the Role :

Reporting to the Director of Medical Operations, this role will manage contracting for the Medical Affairs team and will provide operational support to MLR (Medical, Legal, Regulatory) review process.

You will have the opportunity to utilize your project management skill set to ensure programs are operationally on track, establish best practices for the organization and contribute to special projects.

The ideal candidate will effectively balance the need for organization and adherence to timelines with the adaptability required in a fast-paced, growing company.

You will have a demonstrated record of ensuring successful project outcomes by building strong cross-functional relationships, ensuring clear communication, and efficiently managing team resources to achieve a common goal.

Responsibilities :

• Oversees the procurement and administration of assigned contracts
• Coordinates, reviews, and tracks contract requirements, terms and conditions, and special provisions to ensure fiscal integrity and adherence to contract terms, agency policies, and federal and state laws and regulations
• Issues contract amendments and change orders, monitors contract expiration dates
• Processes invoices for payment
• Assists in monitoring and administering the departmental budget. Prepares cost estimates to assist with budget recommendations.
• Supports Operations Manager to enhance vendor selection, management and oversight including the establishment of preferred vendors
• Manage operational support for MLR (Medical, Legal, Regulatory) Review process
• Administers day-to-day activities, including facilitating cross-functional and team meetings, enabling discussions to drive decision-making, preparing agenda and action items, and ensuring resolution of those action items

Requirements :

• 3 years of experience in contract management or similar roles
• Self-directed individual with a strong sense of passion and urgency who can work both independently and in a cross-functional team environment
• Demonstrated success with handling multiple projects and able to handle complexity and prioritize effectively
• Excellent communication skills with the ability to build relationships with key decision makers from multiple business areas in a highly-matrixed organization
• Excellent project management skills, including the ability to create and manage project plans, budgets, and timelines.
• Demonstrated skill with spreadsheet and database management software / tools, as well as Microsoft Office
• Preferably has familiarity with Agiloft or Avid software
• Excellent communication skills; able to build relationships with key decision makers from multiple business areas in a highly matrixed organization
• Bachelor’s degree required
28 days ago