Muhammed Salem
Clinical Safety Director @Quantum Leap Healthcare Collaborative
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WORK HISTORY
Clinical Safety Director @Quantum Leap Healthcare Collaborative
Build the Clinical Safety function capability to serve as key support for the clinical trialportfolio and medical decision-making- Provide dynamic leadership, strategic direction, and governance of patient safety andpharmacovigilance activities across QLHC portfolio- Invest deeply in team development plans; serve as a coach and mentor to others- Assist in developing, implementing, and communicating the clinical safety vision, goals, corecapabilities, and values while championing clinical safety processes- Collaborate with peers in biostatistics, quality assurance, clinical operations, and otherfunctions to generate, review, and approve governing documents, such as SOPs, OperatingGuidelines, and Safety Management Plans, as necessary, and ensure operational implementation- Ensure continuous improvement and maintenance of operational and management plansrelated to internal and external case processing- Act as a critical facilitator for the clinical safety review carried out by the trials’ safety workinggroups, trial arm chaperones, platform PI’s, and clinical site PI’s- Able to work with leadership to interact with the FDA to develop new and improved approaches to clinical safety- Provide support for safety sections of clinical documents, including the review and approval ofthe safety portion of protocols, annual reports, final study reports, investigator brochure, andother documents, as needed- Proactively assess compliance issues and risks, providing guidance and expertise in GCPcompliance standards- Participate in developing safety data exchange agreements between partners, as required- Communicate critical risks to senior leadership, requiring diplomatic and objectiverepresentation of the issue(s)- Participate in preparations for data reviews, data cleaning, and inspections- Assess global PV requirements for resources, equipment, and systems to maximize efficiency.
EDUCATION
Dar Al Tarbiah
American Diploma, Science
Campbellsville University
Master of Business Administration - MBA, Business Administration, Management and Operations
Northeastern University
Master's degree, Regulatory Affairs for Drugs, Biologics and Medical Devices
Northeastern University
Master of Science - MS, Regulatory affairs
Nahda University - NUB
Clinical Pharmacy
SKILLS
ABOUT MUHAMMED SALEM
I am a Clinical Safety Leader, Scientist, and Pharmacist with a passion for building strong teams and enabling effective decision making. My work focuses on driving data integrity, patient safety, and continuous process improvement across clinical development.With experience leading safety strategy, overseeing adverse event management, and collaborating across cross-functional teams, I believe that success is built on clarity, accountability, and alignment. I approach challenges with a mindset of partnership; coaching teams, facilitating constructive dialogue, and ensuring that processes support both compliance and meaningful outcomes.Muhammed Salem I am particularly interested in initiatives where patient-centricity, operational excellence, and scientific rigor meet. Whether improving safety oversight frameworks, streamlining workflows, or fostering leadership development, my goal remains the same: to create systems that work, empower people, and deliver results that stand up to scrutiny.
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