Manager Clinical Affairs

Role overview

Akura Medical, part of the Shifamed portfolio, is building therapies and software for venous thromboembolism treatment, including its Katana thrombectomy system and NavIQ software platform. The company has also secured a $53 million first close of Series C funding, led by the Qatar Investment Authority, to support a joint venture plus a new R&D and manufacturing facility in Doha, Qatar.

The Clinical Affairs Manager for the MENA region will act as the main clinical and operational owner for setting up and running clinical studies across multiple Middle East and North Africa countries. This Doha-based role covers the full study lifecycle, from choosing sites and handling regulatory submissions to enrollment, data handling, and study closeout. The position suits a highly independent, resourceful professional who can operate well with limited local infrastructure. Candidates with experience in interventional cardiology, interventional radiology, or vascular surgery are strongly preferred, especially those able to provide in-procedure support and physician-level technical assistance.

Key responsibilities

• Lead the regional execution of clinical studies in MENA for both NavIQ and Akura Medical’s pulmonary embolism thrombectomy programs.
• Plan and run studies across IDE, post-market, PMCF, registry, and observational formats, ensuring they fit the company’s regulatory and business strategy.
• Make sure all study activities follow applicable regulations, internal SOPs, and good clinical practice requirements.
• Draft, review, and maintain study documents such as protocols, informed consent forms, CRFs, statistical plans where relevant, and clinical trial agreements.
• Manage site identification, assessment, selection, activation, monitoring, and closure across countries including Qatar, UAE, Saudi Arabia, Egypt, and other MENA markets as needed.
• Oversee start-up work such as ethics and regulatory submissions, budget discussions, and contract completion.
• Keep the Trial Master File and related records complete, organized, and ready for inspection.
• Track site performance, enrollment progress, data quality, and adherence to protocol.
• Create detailed project plans, monitor milestones, and report progress against key performance indicators.
• Coordinate device shipment, accountability records, and regional supply logistics.
• Prepare and deliver regular study updates for the US clinical team and senior leadership.
• Supervise CROs, laboratories, and other external vendors to ensure contracted work is delivered on time and to standard.
• Build and manage study budgets, forecasts, and resource plans while monitoring spend against approved limits.
• Identify operational, schedule, and budget risks and put mitigation actions in place.
• Work through country-specific regulatory requirements to secure approvals for investigational device studies across MENA.
• Ensure all activities comply with ICH GCP, ISO 14155, local regulations, and sponsor procedures.
• Support submissions, audits, inspections, and site readiness for regulatory review.
• Act as the main regional contact for regulatory questions and inspection preparation.
• Provide direct procedural support and case coverage with interventional cardiologists, interventional radiologists, and vascular surgeons during PE thrombectomy cases, where needed.
• Train physicians, coordinators, and site staff on device handling, protocol requirements, and data collection.
• Serve as the clinical and technical bridge between study sites and the sponsor.
• Attend procedures as required and offer live troubleshooting in the cath lab or hybrid operating room.
• Guide and support CRAs and other study team members through training and operational oversight.
• Help improve clinical operations processes, working methods, and best practices.
• Collaborate closely with US clinical affairs, regulatory, R&D, and quality teams to keep regional work aligned with overall program goals.
• Assist with investigator meetings, site training, and regional advisory board planning and execution.

Experience and qualifications

• A bachelor’s degree or above in Life Sciences, Engineering, or a related healthcare discipline is required; an advanced degree or clinical license such as MD, RN, RT, PA, or an equivalent credential is preferred.
• 5 to 7 years of experience in clinical research is needed, including at least 2 years in the medical device sector.
• Prior involvement in pre-market and/or post-market medical device clinical studies is required.
• Practical background in interventional cardiology, interventional radiology, or vascular surgery, either as a clinician, clinical specialist, or field clinical engineer, is preferred.
• Experience in the MENA region is strongly preferred, and the ability to provide case coverage is an important advantage.
• Exposure to PE treatment, VTE management, or catheter-based thrombectomy procedures is highly desirable.
• Strong knowledge of MENA regulatory processes and multi-country submissions, including Saudi Arabia SFDA, UAE MOH/DOH, Qatar MOPH, and similar authorities, is preferred.
• Solid understanding of ICH GCP, ISO 14155, and global medical device trial regulations is required.
• Excellent relationship-building skills with KOLs, physicians, and hospital leadership across MENA are important.
• Strong English written and spoken communication skills are required; Arabic is a major plus.
• Comfort with Microsoft Word, Excel, and PowerPoint, plus experience using EDC platforms and electronic TMF systems, is expected.
• Willingness to travel extensively across MENA, with travel estimated at 50% to 70%, is required.
• Ability to succeed in a fast-moving, cross-functional environment and demonstrate leadership and problem-solving ability is important.

Additional information

Salary is described as being determined by role level and location. Final compensation depends on job-related knowledge, location, skills, experience, education, and certifications. No exact salary figure was provided.

Notice to candidates

The company does not interview or make offers through mobile web chat apps. Any such contact should be reported to hr@shifamed.com.

About the employer

Shifamed, founded in 2009 by Amr Salahieh, is a privately held medical device innovation hub developing new products for cardiology and ophthalmology.