Director

Summary

Accomplished pharmaceutical and toxicology expert with over 19 years of experience in the pharmaceutical and contract research organization (CRO) sectors. Proven track record of managing complex, large-scale operations and optimizing scientific processes to drive global drug development and regulatory success. Specializes in safety assessment, regulatory compliance, and the application of AI and machine learning to accelerate drug discovery and safety evaluations. Expertise in neurological drugs, neurotoxicity, immuno-inflammatory drugs, oncology, and medical device biocompatibility testing. Experienced with global regulatory submissions, including IND, NDA, BLA, and 510K. Strong ability to lead cross-functional teams, integrate scientific strategy with business goals, and align global regulatory strategy with market access requirements.

Expectations

Highly motivated senior biopharmaceutical researcher with leadership experience looking for career growth opportunity to leverage 19 years experience in drug safety assessment, discovery and translational sciences.

Employment Preferences

Expected Base Salary

**8,888 USD

Academic Degree

Experience

Skills

• Global Strategy
• Operations
• Led Global Multidisciplinary Teams
• Managed Multi-region Operations To Ensure Seamless Drug Safety
• Regulatory Compliance Across Therapeutic
• Industry Sectors.
• Regulatory Expertise
• Extensive Preparing
• Reviewing IND
• NDA
• BLA
• 510K Submissions In Compliance With FDA
• OECD
• GLP
• ISO
• EPA Guidelines.
• Innovation In Drug Discovery
• Safety
• Pioneered The Integration
• AI
• Machine Learning
• Digital Image Analysis To Enhance Safety Assessments
• Improving The Efficiency
• Predictive Power
• Preclinical Evaluations In Oncology
• Neurology
• Immuno-inflammatory Research.
• Cross-Functional Leadership
• Collaborated With R&D
• Translational Science
• Clinical Operations
• Senior Stakeholders To Integrate Toxicology
• Pathology
• Safety Data Into Decision-making Processes.
• Strategic Client
• Stakeholder Management
• Managed Key Client Relationships
• Aligned Regulatory Strategies With Client Objectives
• Meeting Timelines
• Maintaining High Standards
• Compliance
• Scientific Integrity.
• Operational Excellence
• Expanded Operations Capacity
• Driving Cost-effective
• Scalable Solutions While Ensuring GLP Compliance
• Delivering High-quality Studies On Time
• Within Budget.
• Risk Assessment
• Safety Evaluation
• Led The Design
• Execution
• Neurotoxicology
• Developmental Neurotoxicity
• Carcinogenicity
• Gene Therapy
• Biocompatibility Testing For Medical Devices
• Ensuring Successful Regulatory Approvals