Director, Clinical Development and Regulatory Affairs

6 days ago

Charlottesville, Virginia, United States The Steely Group Full time
About the Role

The Steely Group is seeking a highly experienced and skilled Executive Director to lead our Clinical Development and Strategy efforts. As a key member of our Medical Team, you will play a pivotal role in shaping the strategic direction of our therapeutic programs and contributing to the advancement of novel treatments.

Key Responsibilities
  • Develop and Implement Clinical Development Plans: Collaborate with our Executive Leadership Team and internal teams to develop and implement a strategic global medical and clinical development plan for clinical programs, ensuring alignment with our company goals and objectives.
  • Design and Conduct Clinical Trials: 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.
  • Provide 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 our 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 and Decision-Making: 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.
  • Medical Input and Guidance: Provide input to life-cycle strategy, planning, and execution with cross-functional stakeholders, including business development, and contribute to the development of KOL engagement plans and build/maintain relationships with key opinion leaders, academic institutions, and research organizations.
  • Team Leadership and Development: Mentor and develop direct reports, fostering professional growth and talent retention, and collaborate closely with cross-functional teams, including clinical operations, preclinical research, and manufacturing.
Requirements
  • Education and Experience: MD or MD/PhD with relevant training and experience in Neurodegeneration (Alzheimer's Disease preferred), with a minimum of 10+ years industry experience in clinical development, preferably within the biopharmaceutical industry and with focus on neurodegenerative diseases.
  • Leadership and Management Skills: 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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