Sr. Dir./Exec. Director, Global Compliance

2 months ago

Cambridge, United States Kalvista Pharmaceuticals Inc Full time
Job DescriptionJob Description

About KalVista Pharmaceuticals, Inc.

KalVista Pharmaceuticals, Inc. is a global pharmaceutical company focused on the development and delivery of oral medicines for diseases with significant unmet need, with an initial focus on hereditary angioedema (HAE). The company disclosed positive phase 3 data for the KONFIDENT trial for its oral, on-demand therapy sebetralstat in February 2024 and submitted an NDA with the FDA in June 2024. KalVista expects to file for approval in the U.K., Europe and Japan later in 2024.

KalVista 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. Listed on the Nasdaq Global Market, our headquarters is located in Cambridge, MA with additional offices and laboratories in Salisbury, U.K.; Zug, Switzerland; Tokyo, Japan and Salt Lake City, UT.

About the role:

We are seeking an accomplished Sr. Director/Executive Director, Global Compliance to join Kalvista’s legal and compliance group to help build and lead a compliance function. This person will provide compliance and business conduct advice and support across the company. This position reports to our General Counsel.

Responsibilities:

  • Serve as a key subject matter expert in supporting the compliance needs of the Company with a specific focus on the Commercial team
  • Expert understanding of the laws, regulations, industry standards, and guidelines for interactions with healthcare professionals and other ethical codes and regulations
  • Advise and counsel on appropriate interactions with healthcare providers, patients, managed care entities, academic institutions, and government entities, including on topics such as fair market value, advisory board participation, sales and marketing
  • Oversee and manage the process and capture of timely, accurate and consistent data for incorporation into filings and reports related to required HCP payment disclosure, including U.S. Sunshine Act and state law reporting
  • Partner with all Company internal clients to clarify and help validate data and prepare reports and filings for transparency data for final attestation by the General Counsel
  • Oversee, manage, and engage in continuous improvement, review, drafting, and project management for all Compliance-specific policies, SOPs, guidelines and work instructions
  • Manage, maintain and document all Compliance training materials, policies, or content (including New Hire Compliance Trainings) and other LMS project management areas
  • Oversee and manage the process, data capture, analytics and report generation for compliance monitoring activities in conjunction with the General Counsel
  • Assist and partner with the General Counsel on various privacy-related projects and policies
  • Keep apprised of applicable federal, state and local laws and regulations and apply them to areas of responsibility
  • Experience with drug advertising and pharmaceutical drug promotion practices and privacy (CCPA and GDPR) required

Requirements:

  • Minimum 10 years of Compliance experience, with at least 5 years in the pharmaceutical industry
  • Bachelor’s degree required. Advanced degree preferred
  • Detail-oriented with a high level of intellectual, professional and interpersonal agility and flexibility
  • Excellent communication skills, both oral and written
  • Well-organized and hardworking, with the ability to handle numerous projects simultaneously under deadline pressure
  • Ability to form strong working relationships with all levels of management, employees, and partners while maintaining firm adherence to proper legal standards
  • Team-oriented, sound judgment, self-motivation and willingness to take initiative

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