- Provide medical monitoring and timely medical guidance for one or more clinical trials
- Review safety data, clinical and medical data, audits, inspections, quality events, and informed consent changes
- Lead clinical execution and deliverables for one or more studies
- Contribute to protocol design and lead protocol development, amendments, and related communications
- Represent study teams in internal protocol governance and support development strategy
- Develop informed consent documents and responses to health authority and ethics committee requests
- Provide clinical guidance for statistical analysis plans, data collection strategies, data review plans, safety review plans, safety narratives, and risk management plans
- Lead review of emerging clinical data, trends, safety data, adverse events, and safety narratives
- Establish and manage External Data Monitoring and Adjudication Committees
- Provide clinical input to site selection, investigator meeting planning, and protocol training
- Serve as primary clinical contact for investigators and study teams
- Manage protocol deviations, clinical queries, TMF compliance, clinical study reports, data disclosure, and publications
- Support audits, inspections, and regulatory filings
- Lead continuous improvement, process enhancement, and innovative clinical-trial execution initiatives
- Potentially manage, supervise, mentor, and develop clinical colleagues or contingent workers
Requirements
- Primary medical degree (e.g., MD, DO, MBBS, MBChB) from a recognized medical school/university
- 7+ years of experience in the biopharmaceutical industry in clinical research and development
- Licensed by a licensing body/health authority to prescribe medicines independently of supervision for at least 2 years after the intern/house officer/foundation period
- Cardiometabolic disease experience preferred, including obesity, diabetes, or endocrinology
- Maintained registration/Medical License to practice and remained in good standing with the Medical Licensing Authority
- Clinical research experience in biopharmaceutical study design, start-up, conduct, and close-out
- Experience with regulatory submissions and inspections
- Scientific productivity through publications, posters, abstracts, and/or presentations
- Extensive knowledge of clinical development, global and regional regulation, and ICH/GCP
- Clinical, administrative, and project management capabilities
- Experience launching, managing, and training clinical development teams
- Track record in pharmaceutical development across design, start-up, conduct, close-out, and reporting
- Understanding of principal disease areas and scientific and regulatory aspects of drug development
- Ability to manage cross-functional teams, complex projects, milestones, budgets, priorities, and resources
- Ability to mentor, coach, delegate to, oversee, and develop others
- Ability to resolve conflicts, negotiate agreements, and escalating issues appropriately
- Ability to deliver results and maintain perspective during uncertainty and organizational change
- Global travel may be required
- Must be authorized to be employed in the U.S. by any employer
- Requires permanent work authorization in the United States; U.S. work visa sponsorship is not available
Core Competencies
Demonstrates extensive clinical research expertise, including protocol development, regulatory submissions, and safety data review. Proven ability to lead cross-functional teams and manage complex clinical trials in the biopharmaceutical industry.
Highest-signal resume keywords
- Clinical Research Experience
- Protocol Development
- Regulatory Submissions
- Project Management
- Cardiometabolic Disease Experience
ATS Optimization Keywords
Hard Skills
- Clinical Trial Execution
- Safety Data Review
- Statistical Analysis Plans
- Data Collection Strategies
- Risk Management Plans
- Clinical Study Reports
- Informed Consent Development
- Quality Event Review
- Adverse Event Analysis
- Pharmaceutical Development
Soft Skills
- Mentoring
- Conflict Resolution
- Negotiation
- Coaching
- Team Leadership
Certifications & Qualifications
- Primary Medical Degree (MD, DO, MBBS, MBChB)
- Medical License
Industry Keywords
- Biopharmaceutical Industry
- ICH/GCP
- Clinical Development
- Global Regulation
- Clinical Trials
- Health Authority Compliance
- Ethics Committee Requests
- External Data Monitoring
- Clinical Queries
- Study Design