Clinical Affairs Manager

Akura Medical, a Shifamed portfolio company, is advancing a differentiated platform for the treatment of venous thromboembolism (VTE), which affects up to 900,000 Americans each year. The company recently received US IDE approval for its QUADRA-PE study evaluating the Katana™ Thrombectomy System in acute pulmonary embolism patients. In parallel, Akura Medical is developing NavIQ™, a software platform that transforms CT angiograms into 3D pulmonary vascular models to enhance visualization, procedural planning, and clot assessment towards better safety, efficacy, and ease of use.

Akura has recently completed a $53 million first close of its Series C financing, led by the Qatar Investment Authority, supporting the launch of a joint venture and a new R&D and manufacturing center in Doha, Qatar.

Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.

The Clinical Affairs Manager (MENA Region) will serve as the primary clinical and operational lead for establishing and managing clinical trials across multiple countries in the Middle East and North Africa (MENA) region on behalf of Akura Medical. Based in Doha, Qatar, this individual will be responsible for all aspects of clinical study execution in the region from site identification and regulatory submissions through enrollment, data collection, and closeout.

The ideal candidate is a highly self‑sufficient, resourceful professional who thrives in an entrepreneurial environment with limited on‑the‑ground infrastructure. A strong preference will be given to candidates with clinical/procedural expertise in interventional cardiology, interventional radiology, or vascular surgery who can provide direct case coverage and physician‑level technical support for interventional procedures alongside treating physicians.

• Serve as the primary operational lead for clinical studies in the MENA region for both NavIQ and Akura Medical’s PE thrombectomy device programs.
• Lead the planning, design, and execution of clinical studies (IDE, post‑market, PMCF, registries, and observational studies) in alignment with business and regulatory strategy.
• Ensures the project is planned and conducted in accordance with all applicable regulations, standard operating procedures, and good clinical practices (GCP).
• Develop, review, and manage clinical study documentation, including protocols, informed consent forms, case report forms (CRFs), statistical plans (as applicable), and clinical trial agreements.
• Coordinate site identification, evaluation, selection, initiation, monitoring, and close‑out activities across multiple MENA countries (including Qatar, UAE, Saudi Arabia, Egypt, and others as applicable).
• Drive all site start‑up activities including regulatory and ethics committee (EC/IRB) submissions, budget negotiations, and contract finalization.
• Manage and maintain inspection‑ready Trial Master File (TMF) and related clinical documentation in compliance with applicable regulations.
• Provide oversight of site performance, enrollment, data quality, and protocol compliance.
• Develops detailed project plans, and monitors project milestones against performance indicators.
• Coordinate investigational device shipments, accountability logs, and supply chain logistics within the region.
• Plan, direct, create, and communicate the study timeline including but not limited to generating reports to provide regular status updates to the US‑based clinical team and senior management.
• Manage and oversee clinical research organizations (CROs), laboratories, and other vendors to ensure delivery of contracted services.
• Develop and manage study budgets, forecasts, and resource plans; monitor expenditures against approved budgets.
• Identify and mitigate operational, timeline, and budgetary risks.

• Navigate country‑specific regulatory landscapes across MENA to obtain necessary…