Medical Director – Clinical Development

Summary: 

The Medical Director in Clinical Development plays a key role in the planning, execution, and oversight of clinical trials and the overall clinical development strategy for investigational drugs or medical devices. The Medical Director will collaborate with cross-functional teams, including clinical research, regulatory affairs, safety, and medical affairs, to ensure the successful implementation of clinical programs. 

Responsibilities: 

• Provide strategic input and leadership in the development of clinical trial protocols and overall clinical development plans. 
• Contribute to the design and selection of appropriate clinical endpoints, study populations, and trial methodologies. 
• Lead the planning, execution, and monitoring of clinical trials to ensure compliance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. 
• Collaborate with study teams to oversee site selection, investigator selection, and study start-up activities. 
• Review and interpret clinical trial data, ensuring accuracy, consistency, and quality. 
• Contribute to the development and implementation of safety monitoring plans, risk mitigation strategies, and safety reporting processes for clinical trials. 
• Assess and evaluate safety data, including adverse events, to ensure patient safety and compliance with regulatory requirements. 
• Participate in interactions with regulatory authorities, such as the FDA or EMA, to support the clinical development program. 
• Provide medical input for regulatory submissions, including Investigational New Drug (IND) applications, New Drug Applications (NDA), and Marketing Authorization Applications (MAA). 
• Contribute to the development of clinical trial protocols, investigator brochures, clinical study reports, and other clinical documentation.  
• Provide medical expertise and guidance to study teams, investigators, and external partners. 

Qualifications: 

• M.D. degree is required. Board certification in a relevant specialty is preferred. 
• Significant experience in clinical research and drug development within the pharmaceutical or biotechnology industry. 
• In-depth knowledge of clinical trial design, GCP guidelines, and regulatory requirements. 
• Strong understanding of medical safety, risk management, and pharmacovigilance. 
• Excellent communication and presentation skills, with the ability to effectively communicate complex medical concepts to diverse audiences. 
• Proven leadership and project management skills, with the ability to lead cross-functional teams and work collaboratively. 
• Ability to analyze and interpret clinical trial data, assess safety risks, and make informed decisions. 
• Detail-oriented with strong organizational and problem-solving skills. 
• Familiarity with medical writing and regulatory submission processes. 
• Proficiency in medical terminology and the ability to critically evaluate scientific literature.