Senior Director of Clinical Development

5 days ago


Charlottesville, Virginia, United States The Steely Group Full time
Job Title: Vice President, Clinical Development

The Steely Group is seeking a highly experienced and skilled Vice President of Clinical Development to lead our medical team in shaping the strategic direction of our therapeutic programs. As a key member of our Executive Leadership Team, you will play a pivotal role in driving clinical development efforts and contributing to the advancement of novel treatments.

Key Responsibilities:
  • Strategic Planning: Develop and implement a global medical and clinical development plan for clinical programs, ensuring alignment with the company's goals and objectives.
  • Clinical Trial Design: Drive the design of clinical trials, including the selection of appropriate endpoints, patient populations, and biomarkers, ensuring trials are conducted ethically, efficiently, and in compliance with regulatory standards.
  • Medical Oversight: Provide medical oversight for ongoing clinical trials, including safety monitoring in collaboration with Pharmacovigilance and data review, and collaborate with clinical operations and safety teams to address clinical issues promptly.
  • Regulatory Affairs: Work closely with the Regulatory team to prepare and submit regulatory filings, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Biologic Licensing Applications (BLAs).
  • Data Analysis: Collaborate with cross-functional teams to analyze clinical trial data, interpret results, and make data-driven decisions to advance program development.
  • Scientific Communication: Contribute to the development of scientific publications, presentations, and communication materials to disseminate clinical trial findings to the scientific community and stakeholders.
Requirements:
  • Education: MD or MD/PhD with relevant training and experience in Neurodegeneration (Alzheimer's Disease preferred).
  • Experience: Minimum of 10+ years industry experience in clinical development, preferably within the biopharmaceutical industry and with focus on neurodegenerative diseases.
  • Leadership: Proven track record of successfully leading clinical development programs from early-phase trials to regulatory submission, with senior managerial experience and a strong understanding of FDA and global regulatory requirements related to Alzheimer's Disease and Neurodegeneration therapeutics.


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