Director, Pricing & Market Access Operations

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 Director, Pricing & Market Access Operations, 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.

As the successful candidate for this position, you will fill a critical operating role within KalVista and report to the Vice President of Market Access. You will be a key member of the Market Access Leadership Team ensuring that our therapies are accessible to patients while maintaining organizational profitability and compliance with regulatory standards. The Director of Pricing and Market Access Operations will collaborate closely with cross-functional teams, including Sales, Marketing, Finance, Legal, and Regulatory Affairs, to optimize pricing models, payer business relationships and Market Access Operating standards.

Responsibilities:

• Develop and implement innovative pricing strategies and programs to enhance patient access and maximize product value

• Collaborate with Market Access and Sales teams to align pricing strategies with market access plans and sales objectives.

• Analyze market trends, competitor pricing, and reimbursement landscapes to inform strategic decision-making.

• Ensure compliance with all federal, state, and industry regulations regarding pricing, operations and managed services.

• Lead managed care strategies including IRA/Medicare coverage gap forecasting, pricing analytics, rebate and chargeback management, government pricing and state transparency reporting.

• Monitor and provide input on policy and regulatory guidelines.

• Lead the development and structure of all pricing documents for presentation to the US Pricing Committee

• Lead strategy development, design, vendor selection, and implementation phases for end-to-end government reporting and managed services

Requirements:

• 10+ years in the biopharmaceutical industry; emphasis in Pricing, Contracting and Managed Services

• Rare disease product launch experience in the US required

• Leadership and interpersonal skills with the ability to effectively engage and influence across multiple organizations within and outside of KalVista

• Proven ability to manage vendor partners regarding a multitude of Market Access and Manged Care offerings

• Innovative mindset with the ability to take a creative approach to best meet the needs of both patients and KalVista

• Strong presentation skills and ability to present to diverse stakeholders

• Strong financial and analytical skills with demonstrated ability to manage and measure results and KPIs using Gross to Net and Financial applications

• Ability to interpret, present and apply financial data as it relates to managed care and healthcare reimbursement

• Bachelor's degree required

• Previous experience working in a pre-commercial biotech company is preferred