Director, Global Evidence & Outcomes Research

Job Description

Job Description

About KalVista Pharmaceuticals, Inc.

KalVista Pharmaceuticals, Inc., is a global biopharmaceutical company dedicated to developing and delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. Our lead investigational product is sebetralstat, a novel, oral, on-demand treatment for hereditary angioedema (HAE). Sebetralstat is under regulatory review by the U.S. FDA, with a PDUFA goal date of June 17, 2025. In addition, we have completed Marketing Authorization Applications for sebetralstat to the European Medicines Agency and multiple other global regulatory authorities.

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

About Sebetralstat

Sebetralstat is an investigational, novel oral plasma kallikrein inhibitor for the treatment of hereditary angioedema (HAE). We have filed multiple regulatory applications seeking approval of sebetralstat as the first oral, on-demand treatment for HAE in individuals aged 12 and older, with ongoing studies exploring its use in children aged 2 to 11. If approved, sebetralstat has the potential to become the foundational therapy for HAE management worldwide.

About the Role :

KalVista seeks a dynamic and experienced Director, Global Evidence & Outcomes Research to support global evidence generation strategy and lead planning and execution of patient-centered evidence generation activities supporting the launch and lifecycle management of clinical-stage assets within the Hereditary Angioedema (HAE) portfolio.

Reporting to the Executive Director, Global Medical Affairs Lead, you will play a pivotal role in ensuring the generation of robust, actionable data that supports global medical affairs strategy execution as well as global regulatory and market access efforts. Collaborating closely with internal stakeholders across Medical Affairs, Market Access / HEOR, Commercial and R&D teams, this role involves extensive external collaboration with HCPs, Healthcare Organizations (HCOs), Patient Advocacy Groups (PAGs) and Medical Societies. You will also oversee large-scale external expert advisory boards and consensus-like meetings, related to the evidence generation projects.

Management.

Responsibilities :

• Support creation of a cross-functional and fully integrated evidence generation plan (IEGP)
• Lead the development & execution of evidence generation strategies and projects that address unmet clinical and patient-centered needs, supporting product value demonstration to regulators, healthcare providers, and patients
• Provide outcomes research leadership, in alignment with HEOR and including the implementation of patient-reported outcomes (PROs) and health-related quality of life (HRQoL) measures, from late-stage clinical development through product commercialization
• Design and oversee the execution of observational and epidemiologic research studies, ensuring timely and effective communication of results to key internal and external stakeholders
• Manage and support generation of real-world evidence (RWE) within global expanded access programs (e.g., post-trial access, compassionate use), contributing to scientific publications and HTA submissions
• Coordinate cross-functional collaboration with Patient Advocacy, Market Access, Marketing, Business Analytics, Development and Regulatory Affairs, ensuring alignment of evidence generation efforts to support value demonstration
• Plan and lead large-scale external expert advisory boards and consensus-type meetings, ensuring input from key opinion leaders (KOLs), clinical experts, and patient representatives to inform the IEGP strategy
• Support design of global evidence generation plans, ensuring they address the full product lifecycle including post-launch
• Lead the design, execution, and analysis of prospective and retrospective observational studies, including longitudinal studies assessing patient outcomes, treatment patterns, comparative effectiveness, drug utilization and disease burden
• Lead and manage investigator-initiated studies (IIS), ensuring scientific rigor, compliance, and alignment with company objectives
• Oversee the execution of interventional studies, including Phase 3b and 4 studies if applicable, contributing to the understanding of long-term clinical outcomes and real-world use of the asset
• Lead implementation of patient-reported outcome (PRO) and health-related quality of life (HRQoL) instruments tailored to the HAE patient population across evidence generation projects
• Design and oversee patient and healthcare provider (HCP) surveys to gather insights on patient outcomes, disease burden and treatment patterns within the HAE space
• Utilize claims data analyses and medical chart studies to generate valuable evidence on disease epidemiology, treatment patterns, and real-world outcomes
• Oversee generation of real-world evidence (RWE) within global expanded access programs (e.g., post-trial access, compassionate use), to support the medical affairs and commercial strategy
• Act as the medical lead for evidence generation related external engagements, including advisory boards, meetings with HCOs, PAGs and relevant regulatory bodies
• Ensure alignment with internal stakeholders on evidence needs to support the global value dossier and reimbursement submissions
• Prepare and review scientific publications, research protocols, statistical analysis plans (SAPs) and technical reports, communicating findings to both internal and external audiences
• Serve as a key resource and thought leader for outcomes research strategy and evidence generation across the HAE portfolio

Qualifications :

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.