Director/Senior Director of Clinical Development

Responsibilities

• Lead the planning, design, execution, and management of clinical trials from Phase I through Phase III, ensuring compliance with regulatory requirements and timelines.
• Serve as point of contact with key opinion leaders and at scientific/regulatory meetings.
• Support patient recruitment on assigned clinical programs, including recruitment strategy and execution in tandem with clinical sites.
• Develop clinical trial protocols, investigator brochures, and other study-related materials.
• Oversee site selection, study initiation, monitoring, and close-out activities in collaboration with the clinical operations team.
• Support interactions with regulatory authorities, including meeting preparation, attendance, and authoring responses to information requests.
• Ensure adherence to Good Clinical Practice (GCP) guidelines and other regulatory standards.
• Collaborate with cross-functional teams, including regulatory affairs, biostatistics, data management, and medical writing, to ensure successful trial execution.
• Manage relationships with clinical research organizations (CROs), investigators, and study sites.
• Monitor clinical trial budgets and timelines, ensuring studies are conducted within scope and on budget.
• Review and interpret clinical trial data, providing clinical and scientific expertise to project teams and ensuring resolution of data related issues during data and protocol deviation reviews.
• Contribute to the preparation of clinical study reports, regulatory submissions, and publications.
• Stay current with industry trends and advancements in clinical research and gene therapy.

Qualifications

• A Medical Degree (MD) in a related field is required.
• 2+ years of experience in clinical research.
• Experience working on clinical trials in the biotechnology or pharmaceutical industry is a plus.
• Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements.
• Excellent organizational, analytical, and problem-solving skills.
• Strong attention to detail and accuracy.
• Ability to work independently and as part of a team.
• Strong interpersonal and communication skills, with the ability to work effectively with cross-functional teams.
• Proficiency in Microsoft Office Suite and clinical trial management software.
• Willingness to travel as required.