Clinical Affairs Director

CLINICAL AFFAIRS DIRECTOR

Innovation prize winner of many contests, Cardiawave is a clinical‑stage company which develops an innovative non‑invasive image‑guided medical device (MD) to treat aortic valve stenosis with ultrasound technology.

Aortic stenosis is a life‑threatening disease and a major public health concern in Western countries (10 million people affected).

The MD uses focused ultrasound therapy to soften aortic valve leaflets and improve valve opening.

The company was created at the end of 2014 as a result of a partnership between the Langevin Institute / Physics for Medicine Paris and the Georges Pompidou European Hospital (HEGP).

Cardiawave currently has 26 employees.

The role

Cardiawave is looking for a Senior Clinical Affairs Director (consulting or part‑time contracts considered – minimum 3 days a week).

The Clinical Affairs Director will define, plan, lead and manage the company’s strategy, planning and execution of clinical research and investigational affairs to support approval and commercialization of Cardiawave’s medical devices while respecting ethical concerns and complying with GCP regulations and relevant worldwide standards.

• Location
• Paris, France
• Employment type
• Full‑time position
• Salary
• To be discussed

Responsibilities

• Results‑oriented, self‑disciplined, fast‑paced, motivated individual capable of multitasking with minimal supervision.
• 10 to 15 years of clinical development experience in the hospital environment or within a medical device company (cardiology field, ideally structural heart).
• Suggest new clinical investigations on the company’s medical devices to extend their indications.
• Support new and ongoing clinical research and clinical trials and ensure timely processing of confidentiality agreements and clinical agreements.
• Monitor adherence to protocols, determine study completion, and ensure logistics, enrollment, training, milestones, study reports, budgets and timelines are met.
• Select, evaluate and monitor suppliers (CROs, core‑labs, vendors), coordinate and supervise their activities in collaboration with the Quality department.
• Approve contracts and budgets with CROs, core‑labs and vendors in collaboration with the CEO; implement legal requirements of contracts, NDAs and financial agreements.
• Prepare and manage clinical affairs budgets.
• Ensure clinical trials comply with European CAB, FDA regulations, IRB approval, legal guidelines, quality standards and GCP requirements.
• Build strong relationships and act as liaison with Key Opinion Leaders, clinical site staff, investigators, clinical consultants and CROs.
• Supervise surveillance activities (post‑market clinical follow‑up, scientific and medical intelligence) and participate in professional organizations or conferences.
• Manage and lead the clinical teams under the director’s authority.
• Organise and lead the company’s Scientific Advisory Board.
• Participate in establishing and updating application files for regulatory submissions and pre‑market approval (EFS, IDEs, PMAs, CE‑marking), market access and reimbursement with the company teams and external resources.

Participate in Quality Management Reviews and the risk management process.

Review and approve Clinical Risk‑Benefit Analyses.

Skills

• 10 to 15 years of clinical development experience (cardiology, structural heart).
• Minimum 5 years proven experience as a Clinical Director and management of projects with clinical professionals and cross‑functional teams.
• Experience implementing and conducting international multicentric clinical investigations in Europe and the USA.
• Experience communicating with Key Opinion Leaders, CAB and Competent Authorities.
• Strong knowledge of clinical methodology, protocol development and applicable standards and regulations (GCP).
• Experience coordinating and supervising subcontractors (CRO, corelab, consultants).
• Excellent leadership, management, collaboration and decision‑making skills.
• Outstanding written, verbal and presentation communication skills.
• Highly organized, detail‑oriented with solid analytical skills.
• Proficient in MS Office Suite (Word, Excel, Power Point), Adobe Acrobat Pro and clinical data management systems.
• English fluent (written and spoken).
• Profile
• Result‑oriented, self‑disciplined, fast‑paced, motivated individual with minimal supervision.
• Ability to independently manage and provide tactical leadership and guidance.
• Ability to deal with ambiguity, swiftly adapt plans to meet changing business and project needs.
• Highly collaborative with aptitude for resolving issues and conflicts.
• Proven problem‑solving skill, anticipating and mitigating issues before delivery.
• Ability to process complex information and summarise it concisely in writing or verbally.
• Ability to prioritize own tasks and team tasks to focus on critical priorities.
• Understand strategic goals and align business needs with the company’s objectives.
• Effective influence of internal and external groups in a diplomatic manner while protecting relationships.
• Strong communication skills in small and large settings, with senior management, regulatory agencies and physicians.
• Additional Information

The Clinical Director may be required to move to clinical sites (hospital or clinic) if necessary.

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