Therapy Development Director

CroiValve; United States; On-site; USD 180,000 - 280,000; Full time

Job summary

CroiValve is seeking a Therapy Development Director to lead cross-functional efforts in developing and executing the clinical adoption strategy for its innovative structural heart device. You will collaborate with Clinical Operations, R&D, Regulatory, and Marketing to drive physician education, site development, and evidence generation.

The role requires strong clinical credibility, commercial awareness, and the ability to operate in a clinical-stage startup environment, with frequent

Qualifications

• Degree or master’s in science, nursing, or related discipline is required.
• Minimum 10 years clinical research experience is required.
• Experience in therapy development, market development, and medical affairs within medical devices is preferred.
• Direct experience in structural heart or interventional cardiovascular therapies is highly valued.
• Startup or early-stage company experience is preferred.

Responsibilities

• Develop and execute the structural heart therapy development strategy in alignment with clinical, regulatory, product development, and commercial objectives.
• Define physician education pathways, procedural adoption, and long-term therapy acceptance.
• Identify clinical, procedural, anatomical, workflow, reimbursement, and evidence-generation factors influencing adoption.
• Support therapy positioning, patient selection criteria, procedural workflow, imaging requirements, and clinical messaging.
• Provide input into clinical development plans, market development, reimbursement considerations, and commercial readiness activities.
• Build and manage relationships with KOLs, investigators, and referral networks.
• Identify centers of excellence and strategically important clinical sites for engagement.
• Support advisory boards, investigator meetings, and case review forums.

Skills

Clinical credibility

Cross-functional collaboration

Strategic thinking

Communication & presentation

Influence without authority

Commercial awareness

Relationship management

Ambiguity tolerance

Education

Degree or master’s degree in science, nursing, or related disciplines

Minimum 10 years clinical research experience

Experience in therapy development, market development, medical affairs or clinical development in medical devices

Direct experience in structural heart or interventional cardiovascular therapies

Startup or early-stage company experience preferred

Tools

Imaging planning and workflow

Echocardiography/CT planning experience

Multimodality imaging workflows

Job description

CroiValve is looking to hire a Therapy Development Director who will be responsible for developing and executing the clinical adoption strategy for the company's innovative medical technology. Working cross-functionally with Clinical Operations, R&D, Regulatory, and Marketing, this leader will build relationships with key opinion leaders (KOLs), establish clinical best practices, support procedure development, and create the foundation for successful market adoption.

This is a highly cross-functional and externally facing role requiring strong clinical credibility, procedural understanding, commercial awareness, and the ability to operate effectively in a clinical-stage start-up environment.

Reporting Lines

Reports to VP of Clinical

Key Responsibilities and Duties

Therapy Development Strategy

• Develop and execute the structural heart therapy development strategy in alignment with the company’s clinical, regulatory, product development, and commercial objectives.
• Define the pathway for physician education, procedural adoption, clinical confidence, and long-term therapy acceptance.
• Identify the key clinical, procedural, anatomical, workflow, reimbursement, and evidence-generation factors that will influence adoption.
• Support development of therapy positioning, patient selection criteria, procedural workflow, imaging requirements, and clinical messaging.
• Provide strategic input into clinical development plans, market development plans, reimbursement considerations, and commercial readiness activities.

KOL and Physician Engagement

• Build and manage relationships with key opinion leaders, investigators, structural heart physicians, interventional cardiologists, cardiac surgeons, imaging specialists, heart failure specialists, and referral networks.
• Identify and engage leading centres of excellence and strategically important clinical sites.
• Support advisory boards, physician steering groups, investigator meetings, case review forums, and expert consultation activities.
• Gather structured physician feedback on clinical need, device performance, procedural technique, patient selection, imaging, workflow, and competitive positioning.
• Represent the company credibly in physician-facing discussions, conferences, workshops, and clinical engagement activities.

Clinical Site Development and Trial Support

• Support clinical operations in identifying, qualifying, activating, and developing clinical sites for feasibility, early clinical, pivotal, and post-market studies.
• Help assess site capability, including procedural experience, imaging capability, referral pathways, enrolment potential, heart team structure, and clinical research infrastructure.
• Work with clinical teams to ensure sites are appropriately trained, engaged, and supported.
• Identify and help resolve site-specific barriers to enrolment, procedural execution, patient selection, imaging, and follow-up.
• Support investigator and site communications in collaboration with clinical operations, medical affairs, regulatory, and quality teams.
• Develop and implement physician training programs for the company’s device and procedure.
• Support creation of training materials, procedural guides, case planning tools, imaging workflows, simulation models, and proctoring pathways.
• Establish a structured approach to physician onboarding, competency assessment, case support, and ongoing education.
• Support hands-on workshops, dry labs, wet labs, simulation-based training, case observation programs and proctored cases as appropriate.
• Collaborate with clinical, R&D, quality, and regulatory teams to ensure all training materials are accurate, controlled, and compliant.

Imaging, Case Planning & Procedure Workflow

• Support development of case planning workflows, including anatomical assessment, imaging requirements, patient selection, procedural steps, and follow-up considerations.
• Work with imaging specialists and physicians to understand imaging requirements for screening, planning, intraprocedural guidance, and post-procedure assessment.
• Support development of practical tools and workflows to improve procedural consistency and physician confidence.
• Capture procedural learnings and translate them into training, product, clinical, and workflow improvements.
• Help define the optimal heart team workflow for adoption of the therapy.

Clinical & Procedure Insights

• Act as a key link between clinical users and internal development teams.
• Collect and synthesize feedback from procedures, sites, investigators, advisors, and case reviews.
• Identify opportunities for product, delivery system, procedural, imaging, workflow, and training improvements.
• Provide input into design requirements, usability, human factors, risk management, clinical protocol development, and evidence-generation strategy.
• Ensure clinical and procedural insights are captured in a structured, traceable, and actionable manner.

Market & Competitive Development

• Develop a strong understanding of the structural heart treatment landscape, competitive technologies, emerging clinical evidence, and market dynamics.
• Identify unmet clinical needs and barriers to adoption in the target therapy area.
• Support segmentation of target physicians, hospitals, centres of excellence, referral networks, and patient populations.
• Contribute to early market access, reimbursement, health economic, and hospital value proposition considerations.
• Provide input into future launch strategy, commercial model, customer targeting, sales force readiness, and strategic partnership discussions.

Cross-Functional Collaboration

• Work closely with clinical operations, regulatory, quality, R&D, marketing, commercial, and executive leadership.
• Ensure therapy development activities are aligned with regulatory constraints, clinical study requirements, product development priorities, and quality system expectations.
• Support translation of clinical and market insights into company strategy, product requirements, training plans, clinical protocols, and evidence-generation plans.
• Collaborate with communications and marketing teams on congress strategy, scientific presentations, publications, and physician-facing materials.
• Support Board, investor, and strategic partner updates where therapy development and clinical adoption insights are required.

External Representation

• Represent the company at structural heart conferences, industry events, physician meetings, training programs and strategic partner discussions.
• Build awareness of the therapy among relevant clinical communities in a controlled and compliant manner.
• Support the development of the company’s scientific and clinical presence in the structural heart field.
• Maintain professional credibility with clinicians, investigators, advisors, and hospital stakeholders.
• Ensure all external engagement is consistent with the company’s clinical, regulatory, and compliance requirements.
• Ensure interactions with colleagues/stakeholders fully reflects the company values:
• One Team: working together to ensure the whole is greater than the sum of the parts
• Personal Ownership: deliver on commitments
• Open Communication: Honest open-minded communication
• Fun: celebrate the successes
• Continuous Learning: at an individual and company level
• Solution Orientated: Identify problems but focus your energy on solutions
• Quality Focused: patient safety comes first
• Strong structural heart clinical and procedural credibility.
• Excellent physician engagement and relationship management.
• Strategic thinking with practical execution capability.
• Ability to influence without direct authority.
• Strong understanding of therapy adoption and market development.
• Ability to identify clinical, procedural, anatomical, imaging, workflow, and commercial barriers to adoption.
• Strong communication and presentation skills.
• Cross-functional collaboration.
• Commercial awareness and competitive insight.
• High integrity and compliance awareness.
• Ability to operate effectively in ambiguity.

Education and Experience

• Degree or master’s degree in science, nursing, or related disciplines
• Minimum 10 years clinical research experience
• Significant experience in therapy development, market development, medical affairs, clinical development, field clinical leadership, or commercial strategy within the medical device industry.
• Direct experience in structural heart, interventional cardiology, transcatheter therapies, heart failure, or other complex procedure-based cardiovascular therapies.
• Familiarity with imaging-led procedures, including echocardiography, fluoroscopy, CT planning, or multimodality imaging workflows is preferred.
• Strong understanding of clinical adoption pathways for novel medical device therapies.
• Experience working directly with physicians, key opinion leaders, investigators, and clinical sites.
• Experience supporting clinical studies, site development, physician training, case support, or early commercialisation activities.
• Startup or early-stage company experience strongly preferred.

Availability to travel is required

The above role profile is not designed to cover a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned from time to time.