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Director, Global Evidence & Outcomes Research

Cambridge, MA, US

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:

  • Advanced degree (MD, PhD, PharmD, or equivalent) in a relevant field such as health services research, health outcomes research, epidemiology, pharmacoeconomics or related disciplines
  • At least 8-10 years of experience in outcomes research or medical affairs with significant experience in the design, execution and management of global evidence generation activities in the life sciences industry
  • Proven track record of leadership in designing and executing patient-centered evidence generation strategies across the full lifecycle of clinical-stage assets
  • Expertise in the development of patient-reported outcomes (PROs) and health-related quality of life (HRQoL) assessments, with demonstrated success in applying these tools to clinical and market access strategies
  • Significant experience in designing, managing, and overseeing investigator-initiated studies (IIS), interventional studies, Phase 3b/4 trials, and real-world evidence generation (e.g., claims data analyses, medical chart studies)
  • Strong experience managing large-scale external expert advisory boards, consensus-type meetings, and interactions with regulatory authorities and other key stakeholders
  • Strong organizational and project management skills, with the ability to manage multiple priorities, timelines, and cross-functional teams in a matrixed multicultural global environment
  • Proven ability to work collaboratively across departments and regions, fostering a culture of cross-functional partnership and driving evidence generation that supports both medical affairs and commercial objectives
  • Exceptional communication skills with experience in preparing high-impact scientific documents, presenting to senior leadership and external experts and publishing peer-reviewed outcomes research
  • Extensive experience collaborating with external vendors, Healthcare Organizations (HCOs), Patient Advocacy Groups (PAGs), and Medical Societies to drive evidence generation efforts
  • A demonstrated record of global, cross-functional team leadership and a deep understanding of the regulatory, clinical, and commercial environments in pharmaceutical development
  • Experience in outcomes research specific to rare diseases or complex patient populations such as HAE preferred
  • A track record of successful peer-reviewed publications in outcomes research or related fields
  • Demonstrated success in leading global, cross-functional teams in a matrixed organization, ideally within the context of late-stage clinical development and commercialization 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.

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