Manager, Compliance Operations

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. KalVista announced positive phase 3 data from the KONFIDENT trial for its oral, on-demand therapy, sebetralstat for HAE in February 2024. The Company’s NDA for sebetralstat has been accepted by the FDA with a PDUFA goal date of June 17, 2025. KalVista received validation of its MAA from the EMA in August 2024. KalVista expects to file for approval in the UK, Japan, and other countries later in 2024.

For more information about KalVista, please visit www.kalvista.com or follow-on social media at @KalVista and LinkedIn.

About the role:

KalVista is seeking a Manager, Compliance Operations to collaborate with internal and external stakeholders to implement a best-in-class compliance program. The ideal compliance professional will possess solutions-oriented pragmatism, excellent communication skills, and attention to detail. The Compliance Operations Manager will drive accountability together with business leaders to generate trust from customers, business partners, and patients.

Responsibilities:

• Assist in the development, revision, and pull through of policies, procedures, and training
• Support implementation of transparency reporting program, including federal and state aggregate spend reporting, certification, and disclosure
• Support KalVista Pharmaceutical’s cross-functional privacy initiatives and project plans to ensure on-track, timely completion in compliance with all applicable laws and codes
• Support execution of Compliance Committee materials and activities
• Assist in operationalizing KalVista Pharmaceutical’s compliance training program, including collaborating with internal stakeholders on assignments and communications plans
• Perform training as needed to reinforce values-based decision making and compliance program
• Implement planned audits and monitoring activities as applicable, trending and reporting results to the Compliance & Risk team, Compliance Committees, and other business stakeholders
• Transactional review of business activities, such as advisory boards, speaker programs, sponsorships/exhibits, and medical education initiatives for FCPA, fraud and abuse, FDA and other regulatory agency compliance, as well as in consideration of transparency reporting, anti-kickback, anti-bribery, antitrust, privacy, and product liability laws, rules, regulations, and guidance
• Maintain awareness of existing and evolving compliance, ethics, privacy and related legislation, regulations, frameworks, and other marketplace/industry dynamics relevant to KalVista Pharmaceutical and its industry, business, and operations to determine the practical effects on and requirements for KalVista Pharmaceutical’s programs, policies, communications, and training needs
• Provide administrative support for internal investigations, including managing the intake process for concerns received through the company hotline, conducting a high-level review and triage of investigations, scheduling interviews, and assisting with gathering supporting documents

Qualifications:

• Bachelor’s degree required
• Minimum of 3 years of compliance experience in the Pharmaceutical/Biotech/Life Sciences industry
• Outstanding skills and proven track record working with business owners on writing and modifying policies/SOPs
• Demonstrated pragmatism and operational focus, seeking to assist others in finding practical, business solutions
• Sound, agile decision-making and interpersonal/networking skills
• Strong oral and written communication skills
• Must be detail-oriented, precise, and meticulous when reviewing data and records amid demanding deadlines
• Knowledge of Sunshine Act and state transparency reporting, preferably experience with Open Payments preferred
• Privacy experience preferred

KalVista is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

Important Notice to Third-Party Recruiters & Staffing Agencies:

The current job openings advertised on this website are for the sole purpose of candidates to apply directly. Unsolicited and anonymous CVs submitted in any manner to KalVista employees, including to employee personal e-mail accounts, are considered to be the property of KalVista and will not qualify for a fee to be paid. Referral fees will only be payable where KalVista has agreed with an agency to work on a specific appointment, and then only in conjunction with a fully executed contract for service.

If any Agency representative contacts a KalVista Hiring Manager or company employee, other than a member of the KalVista Talent Acquisition team, to solicit an appointment to engage on a job opening, that Agency will not be considered for that specific job opening or future opportunities with KalVista.

Thank you for your understanding and cooperation.