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.

ABOUT SHIFAMED

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.

Description:

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.

Responsibilities, Skills & Hands-On Experience:

Regional Clinical Trial Setup & Management

• 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.

Regulatory & Compliance

• Navigate country‑specific regulatory landscapes across MENA to obtain necessary approvals for investigational device studies.
• Ensure all clinical activities comply with ICH GCP, ISO 14155, local regulatory requirements, and sponsor SOPs.
• Support preparation of regulatory submissions, audits, and inspections.
• Prepare sites for potential regulatory inspections; serve as the primary regional contact for regulatory queries.
• Manage risk assessment and mitigation.
• Provide direct procedural support and case coverage alongside interventional cardiologists, interventional radiologists, and vascular surgeons performing PE thrombectomy procedures using NavIQ and Akura devices (preferred).
• Train physicians, clinical staff, and coordinators on device use, study protocols, and data collection requirements.
• Serve as the primary technical and clinical liaison between study sites and the sponsor.
• Attend cases as needed and provide real‑time guidance and troubleshooting support in the catheterization lab or hybrid OR.

Cross‑Functional Collaboration

• Provide guidance, training, and operational oversight to Clinical Research Associates (CRAs) and other study team members, as applicable.
• Contribute to continuous improvement of clinical operations processes, procedures, and best practices.
• Work closely with US‑based clinical affairs, regulatory, R&D, and quality teams to align regional activities with overall program goals.
• Support planning and execution of investigator meetings, site training sessions, and regional advisory boards.

Education & Work Experience:

• Bachelor’s degree or higher in Life Sciences, Engineering, or a related healthcare field (advanced degree or clinical licensure preferred e.g., MD, RN, RT, PA, or equivalent).
• 5–7 years of experience in clinical research, with minimum of 2 years in the medical device industry.
• Demonstrated experience managing pre‑market and/or post‑market medical device clinical studies.
• Hands‑on experience in interventional cardiology, interventional radiology, or vascular surgery (either as a clinician, clinical specialist, or field clinical engineer).
• Direct experience in the MENA region is highly preferred; ability to provide direct case coverage is a significant advantage.
• Familiarity with PE treatment, VTE management, or catheter‑based thrombectomy procedures is strongly preferred.
• Deep understanding of MENA regulatory environments and experience navigating multi‑country clinical submissions (Saudi Arabia SFDA, UAE MOH/DOH, Qatar MOPH, and others).
• Strong knowledge of good clinical practice (ICH GCP, ISO 14155), and international regulatory requirements for medical device trials.
• Excellent interpersonal skills with demonstrated experience building relationships with KOLs, physicians, and hospital administration across the MENA region.
• Strong written and verbal communication skills in English; Arabic language proficiency is a significant plus.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint); experience with EDC systems and electronic TMF platforms.
• Willingness and ability to travel extensively within the MENA region (50–70% travel expected).
• Ability to work effectively in a fast‑paced, cross‑functional environment.
• Demonstrated leadership and problem‑solving capabilities.

Our salary ranges are calculated by role, level, and location. Please note that your position within that range will be determined by your job‑related knowledge, location, skills, experience, relevant education, and training/certifications.