Senior Clinical Affairs Director

CLINICAL AFFAIRS DIRECTOROTHER INFORMATION

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 which is 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 long-term partnership between the Langevin Institute / Physics for Medicine Paris, a world leader in ultrasound imaging and therapy, and the Georges Pompidou European Hospital (HEGP), a leader in the field of valve disease and cardiac ultrasound imaging. Cardiawave currently has 26 employees.

Veuillez lire attentivement les informations de cette offre d'emploi pour comprendre exactement ce qui est attendu des candidats potentiels.
The role

Cardiawave is looking for its (Senior) Clinical Affairs Director (Consulting or part-time contracts will be considered – minimum 3 days a week). As our Clinical Affairs Director, you will be responsible for defining, planning, leading and managing the company’s strategy, planning, and execution of clinical research and investigational affairs for the company, in order to support approval and commercialization of CARDIAWAVE’s medical devices with respect for ethical concerns and in full compliance with applicable GCP regulations as well as relevant worldwide standards and regulations.

LOCALIZATION

Paris, FRANCE

Type of employment

Full-time position

SALARY

To be discussed

THE RESPONSABILITIES

• Results-oriented, self-disciplined, fast-paced, motivated individual that requires minimal supervision and able to multitask several projects at one time.

• 10 to 15 years clinical development experience in the hospital environment or within a scientific or clinical department of a medical device company (in the cardiology field, ideally in structural heart).

• Suggest new clinical investigations on the COMPANY’s Medical Devices in order to extend their medical indications.

• Support new and ongoing clinical research and clinical trials and ensure efficient and timely processing of confidentiality agreements and clinical agreements.

• Monitor adherence to protocols and determine study completion.

• Ensure the logistical details, study protocols, enrollment, training needs, milestones, clinical study reports, budgets and timelines are met for all studies.

• Select, evaluate and monitor suppliers involved in clinical activities (e.g. CROs, core-labs and vendors), in collaboration with the Quality department and coordinate and supervise their activities.

• Approve in collaboration with the CEO contracts and budgets with CROs, core-labs and vendors. Implement legal requirements of contracts, non-disclosure agreements, and financial agreements in clinical programs.

• Prepare and manage clinical affairs budgets.

• Ensures that clinical trials and studies are executed in accordance with European CAB and Food and Drug Administration (FDA) regulations, Institutional Review Board (IRB) approval, legal guidelines, policies and quality standards, and Good Clinical Practices (GCPs) requirements, regulations, and standards.

• Build strong relationships and act as the liaison with Key Opinion Leaders, clinical site staff (PI’s-MD’s), investigators, clinical consultants, other medical professionals, and Contract Research Organizations (CROs)

• Supervise activities of surveillance (incl. Post market clinical follow-up and scientific and medical intelligence), in particular participate in professional organizations or conferences to keep abreast of developments in the TAVR, and implement an action plan when appropriate.

• Manage and lead the clinical teams under his authority.

• Organize and lead the COMPANY’s Scientific Advisory Board.

• Participate in establishing and updating application files for regulatory submissions and pre-market approval (e.g EFS, IDEs, PMAs, and PMA supplements, CE-marking), market access (e.g. reimbursement) of the COMPANY’s Medical Devices in collaboration with the COMPANY teams and external resources if any. Participate in Quality Management Reviews as well as in the Risk management process. Review and approve Clinical Risk-Benefit Analyses.

THE SKILLS

• Results-oriented, self-disciplined, fast-paced, motivated individual that requires minimal supervision and able to multitask several projects at one time.

• 10 to 15 years clinical development experience in the hospital environment or within a scientific or clinical department of a medical device company (in the cardiology field,