Executive Director/VP, Clinical Development(Remote)

Job Title: Director/Executive Director Clinical Development(Remote)

Job Number: 35670

Location: Remote, 

Job Description

The Executive Director of Clinical Development will oversee all aspects of clinical development activities, providing strategic and medical leadership to ensure the successful planning, execution, and reporting of clinical trials. This role requires a strong background in neuroscience or related therapeutic areas, with a preference for experience in psychiatry or neurology. The role is critical in driving innovative clinical programs and advancing investigational treatments.

Responsibilities

Design, plan, and provide medical oversight of clinical studies across all phases of development.  
– Collaborate with Clinical Operations on study implementation and act as the Medical Monitor.
– Oversee the interpretation and dissemination of study results, including clinical study reports and publications.  
– Serve as a core member of the clinical development team, contributing to overall clinical strategy and ensuring compliance with applicable regulations.  
– Support executive leadership by providing medical input into clinical program design, strategic planning, and tactical execution.  
– Provide oversight of clinical programs, ensuring execution and completion of clinical trials in alignment with regulations, ICH/GCP guidelines, and internal SOPs.  
– Partner with Clinical Operations to ensure timely and compliant completion of all clinical study activities.  
– Review clinical data from all phases of development, assisting in the generation of study reports and publications.  
– Manage communication and collaboration with internal departments (e.g., Legal, Regulatory, Drug Safety, Finance) and external vendors (e.g., CROs, consultants) to achieve study objectives.  
– Develop and implement SOPs for clinical trials and ensure compliance with regulatory standards.  
– Build and maintain professional relationships with academic and community-based study sites.  
– Provide executive management with updates on project scope, schedule, and resource needs.

Required Skills

– M.D. degree preferred, with expertise in neuroscience (psychiatry, neurology) or significant clinical trial experience in neuroscience.  
– Minimum of 9 years of experience in the biotechnology/pharmaceutical industry, including 5+ years in clinical trials management or clinical development leadership.  
– Demonstrated ability to design, manage, and execute clinical trials across all phases of development.  
– Strong knowledge of FDA and ICH regulations, as well as clinical medicine, pharmacology, and related disciplines (e.g., biostatistics, data management, medical writing).  
– Expert knowledge of Good Clinical Practice (GCP).  
– Proven ability to manage multiple projects in parallel, ensuring attention to detail and timely resolution of issues.  
– Excellent project planning, leadership, negotiation, and presentation skills.  
– Significant experience communicating complex information to senior management and cross-functional teams.  
– Highly motivated, entrepreneurial mindset with the ability to drive results in a fast-paced environment.  
– Strong ability to build effective relationships with internal teams and external partners.