Sr. Mgr. Medical Information & Communication

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 and LinkedIn.

About the role:

As a Senior Manager, Medical Information and Communication you will be responsible for developing, reviewing, and updating local medical information content. This role will oversee the day-to-day implementation of the global Medical Information strategy, ensuring the delivery of evidence-based information to both internal and external stakeholders. This role will also support medical communication activities.

Responsibilities:

• Assist with the creation of a comprehensive medical information strategy for and lead implementation efforts
• Develop and lead all functional aspects of the Medical Information role
• Create, review, and update standard response documents and FAQs
• Develop and maintain a comprehensive knowledge database to house SRDs, FAQs, and other essential communications and informational documents
• Respond to medical information inquiries in a timely manner, escalating issues where appropriate and ensuring cross-functional communication with key internal stakeholders as necessary
• Develop and manage a contact center, monitoring closely for quality and effectiveness
• Act as the medical reviewer for all promotional and non-promotional materials
• Oversee quality control to ensure all medical information activities comply with regulatory requirements, industry standards, and company policies.
• Conduct regular audits and quality checks
• As needed, participate in the execution of medical communication deliverables
• Completes all assigned SOPs and training within designated timeframe and adheres to job-specific SOPs and work instructions
• Support medical and scientific discussions, presentations, data exchange, and internal training and education through ongoing dialogue with and support to the field-based teams
• Aggregate, analyze, and derive scientifically significant conclusions from shared data and issue reports to relevant stakeholders
• Stay up to date on scientific publications and congress activities in the therapy area and circulate relevant papers to stakeholders
• Represent KalVista Pharmaceuticals and own the information both for congresses, conferences, and other events
• Vendor and contractor management including performance, quality, and budget oversight
• Acts as a subject matter expert for one or more therapeutic areas (TAs)
• Proactively develops and updates local medical information content that is current, complete, medically accurate, and fair- balanced

Qualifications:

• 5+ years of experience in Medical Information services for the pharmaceutical industry.
• Launch experience preferred
• Thorough understanding of the medical/promotional review process
• Demonstrated experience providing medical review of MLR materials
• Experience using and implementing medical information databases and supporting software
• Experience developing and distributing scientific materials pertaining to pharmaceuticals
• Proficient in medical writing for medical information response documents
• Ability to summarize medical literature/ accurately and appropriately (creating medical information response documents that are accurate, current, scientifically fair- balanced, and of high quality)
• Outstanding communication skills to relay complex information in a comprehensive way to both internal and external audiences
• Travel up to 10%

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.