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.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Staffing and Recruiting
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