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 Sr. Manager/Associate Director, Marketing 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.

Reporting to the Sr. Director, U.S. HCP Marketing & Launch Lead, you will lead and provide marketing operations support for the Commercial organization with a focus on the promotional review process, materials production and fulfilment, congress and other meeting and events. Ensuring business needs are met in a compliant, efficiently organized way is vital to success in this role. As a talented and experienced marketing operations professional, you will play a crucial role in shaping our marketing operations function and driving initiatives to support the company’s growth and success. 

Responsibilities:

• Serve as promotional review committee lead and work collaboratively with key cross-functional partners to optimize process to compliantly and efficiently meet the needs of the commercial organization

• Lead and direct the print, digital content, and fulfilment process - including fulfilment portal system implementation, process documentation, socialization/training documents, forecasting, and projection methodology
• Direct experience in promotional or non-promotional material review processes and systems within the biotech/pharmaceutical industry
• Support brand launches with the MLR process through print production
• Develop and implement MLR processes to facilitate review and approval of marketing materials in compliance with regulatory requirements.
• Oversee meetings and events including congresses, field speaker programs, internal meetings, etc.
• Collaborate with internal stakeholders, including marketing, legal, regulatory, and compliance teams, to streamline processes and ensure alignment on marketing initiatives
• Establish and maintain Standard Operating Procedures (SOPs) for marketing operations to ensure consistency and compliance with industry regulations
• Monitor and analyze performance metrics related to marketing operations processes, identifying areas for improvement and implementing solutions
• Manage relationships with external vendors and agencies to support marketing operations activities as needed
• Highly organized with an exceptional attention to detail

Requirements:

• 3+ years of experience in marketing operations, with a focus on MLR processes and compliance in the biotechnology or pharmaceutical industry
• Experience in working with various MLR technical and organizational tools
• Strong analytical skills with the ability to interpret data, identify trends, and make data-driven decisions
• Experience collaborating with cross-functional internal teams to create and implement standardized SOPs
• Direct experience in promotional or non-promotional material review processes and systems

• Experience proofreading of technical documents 
• Capable of engaging senior management and external agency partners
• Knowledge of project management tools and experience using collaboration tools such as SharePoint and Smartsheet
• Expert listening skills and with a strong attention to detail and ability to work independently.

• Ability to travel occasionally including overnight stay driven by business need

• Bachelor's degree in Marketing, Business Administration, or related field