Vice President, Clinical Development

2 months ago

Charlottesville, United States The Steely Group Full time

Our client is seeking a Vice President of Clinical Development to join their Medical Team.  Reporting to the Chief Medical Officer, this position will play a pivotal role in leading clinical development efforts, shaping the strategic direction of therapeutic programs, and contributing to the advancement of novel treatments.  In addition, this role will lead a team of physicians and clinical research scientists and provide mentorship and guidance to foster a culture of excellence.

Responsibilities:
  • Develops and implements a strategic global medical and clinical development plan for clinical program, in collaboration with the Executive Leadership Team and other internal teams/functions such as Clinical Operations, Medical Affairs, Regulatory, Bioanalytical, and Marketing, ensuring alignment with the company’s goals and objectives.
  • Drives the design of clinical trials, including the selection of appropriate endpoints, patient populations, and biomarkers. Ensures trials are conducted ethically, efficiently, and in compliance with regulatory standards.
  • Provides medical oversight for ongoing clinical trials, including safety monitoring in collaboration with Pharmacovigilance and data review. Collaborates with clinical operations and safety teams to address clinical issues promptly.
  • Works 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).
  • Collaborates with cross-functional teams to analyze clinical trial data, interpret results, and make data-driven decisions to advance program development.
  • Provides input to life-cycle strategy, planning and execution with cross-functional stakeholders, including business development. 
  • Contributes to the development of scientific publications, presentations, and communication materials to disseminate clinical trial findings to the scientific community and stakeholders.
  • Reviews external-facing materials for scientific and medical accuracy, including promotional materials.  
  • Provides appropriate medical input for Medical Affairs activities and other related company activities.  
  • Collaborates with Medical Affairs to support the development of KOL engagement plans and build/maintain relationships with key opinion leaders, academic institutions, and research organizations.
  • Mentors and develops direct reports, fostering professional growth and talent retention. 
  • Collaborates closely with cross-functional teams, including clinical operations, preclinical research, and manufacturing.
  • Participates in and/or facilitates the presentation of data and associated discussion at key events and other outreach activities, particularly the planning and participation in congresses.
  • Stays abreast of scientific literature and emerging trends in Alzheimer's Disease and Neurodegeneration research to guide the company's scientific direction.


Knowledge & Skills:
  • Excellent communication and leadership skills, with the ability to work effectively in cross-functional teams. 
  • Demonstrated ability to manage and mentor a team of medical professionals. 
  • Ability to think critically, solve complex problems, and make informed decisions based on clinical data.
  • Strong strategic and leadership presence.
  • Ability to work effectively with other clinical and scientific leaders.
  • Demonstrated leadership and management skills with the ability to influence and work effectively across functions/departments.


Requirements:
  • MD or MD/PhD with relevant training and experience in Neurodegeneration (Alzheimer’s Disease preferred).
  • Minimum of 10+ years industry experience in clinical development, preferably within the biopharmaceutical industry and with focus on neurodegenerative diseases. 
  • Proven track record of successfully leading clinical development programs from early-phase trials to regulatory submission. 
  • Senior managerial experience with track record of leading and inspiring teams.
  • Strong understanding of FDA and global regulatory requirements related to Alzheimer's Disease and Neurodegeneration therapeutics.

 

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