Head of Therapy Development
P+F, Products and Features

Position Overview

 

Products + Features, (website) is a global player in minimally invasive structural heart devices. Generating more than €20M in annual revenue, receiving Breakthrough Devices Designation for its TricValve Transcatheter Bicaval Valves System treating patients with severe tricuspid regurgitation, P&F is beginning enrollment for a 400-patient Randomized Control Trial (RCT).

 

Technology Video: TricValve System

Technology Article: P&F Secures FDA Approval for Pivotal Trial

P&F Article: TricValve and Tricuspid Therapies at TCT

 

We have partnered with Katharina Kiss, CEO of P&F, to hire a Head of Therapy Development. This position will drive patient enrollment, manage and grow the 4-person U.S. clinical team, support global strategic planning, and lead the U.S. Pivotal IDE. The Head of Therapy Development will continue to advance the 110-patient single-arm study launched in 2024 while preparing enrollment for the Randomized Control Trial (RCT) in 2026.

 

​​Responsibilities ​

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Therapy & Clinical Strategy

• Own the therapy development strategy for transcatheter structural heart programs (e.g., TricValve TAVR, TMVR, transcatheter repair).

• Define target patient populations, indications, and positioning relative to surgical and transcatheter alternatives.

• Translate unmet clinical needs into therapy concepts, clinical claims, and device requirements.

• Guide treatment algorithms and integration into heart team workflows.

Product & R&D Collaboration

• Partner with R&D, engineering, and systems teams to ensure therapy-driven device design.

• Provide clinical leadership on access routes, delivery systems, implant techniques, and device durability considerations.

• Support design control activities, including usability, human factors, and risk management (ISO 14971).

• Participate in design reviews, verification, and validation from a clinical and therapeutic standpoint.

Clinical Development & Evidence Generation

• Engage and manage relationships with global KOLs, investigators, and heart teams.

• Ensure evidence generation supports regulatory approval, guideline inclusion, and reimbursement.

Regulatory & Quality Interface

• Provide clinical and therapeutic input to global regulatory submissions (FDA, EU MDR, PMA/CE).

• Support IDEs, clinical evaluation reports, PMA modules, and interactions with regulatory authorities.

• Ensure compliance with GCP, clinical investigation standards, and company quality systems.

Commercial & Market Enablement

• Collaborate with Marketing, Medical Affairs, and Commercial teams on clinical messaging, therapy value propositions, and claims substantiation.

• Support training programs, case proctoring strategy, and scientific communications.

• Contribute to reimbursement and health economics strategies by articulating clinical and procedural value.

Leadership & External Representation

• Lead and develop a therapy development team spanning clinical, scientific, and medical functions.

• Serve as a clinical thought leader representing the company with physicians, regulators, and scientific societies.

• Participate in advisory boards, congresses, and guideline-shaping initiatives.

 

​​Qualifications

 

Education

• Advanced degree: MD, PhD, or equivalent

• Interventional cardiology or structural heart clinical training strongly preferred

Experience

• 10+ years in structural heart, interventional cardiology, or cardiovascular medical device development

• Demonstrated leadership of transcatheter therapy programs from concept through commercialization

• Direct experience with early feasibility and pivotal clinical trials

• Strong familiarity with FDA IDE/PMA pathways

• Proven track record working with global KOLs and heart teams

Skills & Competencies

• Deep understanding of structural heart disease pathophysiology and treatment paradigms

• Expertise in catheter-based device development and procedural workflows

• Strategic and operational leadership in complex, cross-functional environments

• Strong communication, scientific writing, and executive presentation skills

Preferred Qualifications

• Prior leadership role in TAVR, TMVR/TTVR, or transcatheter repair programs

• Experience with guideline-driven evidence generation

• Exposure to reimbursement, health economics, and post-market surveillance

• Experience in both early-stage innovation and late-stage commercial programs

 

What We Offer

• Opportunity to shape next-generation transcatheter tricuspid therapies with significant patient impact

• Executive-level influence across clinical, R&D, and commercial functions

• Competitive compensation and incentives

• Dynamic, innovation-driven structural heart environment

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Company Overview 

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As a global leader in cardiovascular medical technology, we’re reimagining the treatment of mitral and tricuspid regurgitation through the development of innovative, minimally invasive solutions. Headquartered in Vienna, Austria, with operating facilities in Germany, Portugal, Spain, and Brazil, our global presence enables us to expand access to state-of-the-art technologies for patients and healthcare providers worldwide.

 

With over 25 years of experience in the medical field, our leadership team has built a fully integrated global value chain that sets us apart. By connecting research, development, manufacturing, and distribution across continents, we deliver significant innovations and add economic value for our customers.

Innovation that Matters

At P&F Products & Features, we design innovative solutions that redefine possibilities in cardiovascular healthcare. Our minimally invasive devices are engineered to offer safer, more effective alternatives to traditional procedures, fostering quicker recoveries and better outcomes for patients. By developing comprehensive in-house solutions that minimize third-party dependencies, we address critical limitations of current cardiac treatment approaches for heart valve replacements. 

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From pioneering new technologies to enhancing current therapies, we are committed to delivering solutions to transform patient outcomes and quality of life by providing safer, more effective alternatives to high-risk surgical interventions.

Anteris Technologies Team

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