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Vice President Clinical Development

3 months ago

Cambridge, United States Theery Full time

About the Role:


We are seeking an experienced Senior Director/Vice President, Clinical Development Operations to lead our clinical development programs. Reporting directly to the Chief Medical Officer (CMO), the Senior Director/ VP of Clinical Development Operations will play a crucial role in overseeing clinical trials, contributing to clinical program design and ensuring successful execution of development plans. Position title will be based on experience level and one’s ability to take on more strategic aspects of clinical development and trial design.


Responsibilities:


  • Leadership: Provide leadership over clinical development operations function and professionals, fostering a culture of innovation, collaboration, and excellence.
  • Trial Design and Execution: Work with Chief Medical Officer to design Clinical Programs. Oversee the implementation, and management of clinical trials, ensuring adherence to timelines, budgets, and quality standards.
  • Regulatory Compliance: Ensure all clinical trials comply with regulatory requirements and industry standards, maintaining high ethical and scientific standards.
  • Risk Management: Identify potential risks and develop mitigation strategies to ensure successful clinical trial outcomes.
  • Clinical Strategy: Provide input to the design of clinical development strategies aligned with corporate goals and regulatory requirements.
  • Collaboration: Work closely with cross-functional teams including regulatory affairs, medical affairs, pharmacovigilance, and commercial teams to integrate clinical development plans into overall business strategies.
  • External Partnerships: Oversee the management of clinical investigators, CROs, and other external partners to support clinical trial activities. Contribute to the management of relationships with key opinion leaders.
  • Data Analysis: Provide input into the analysis and interpretation of clinical trial data, ensuring accurate reporting and presentation of results.
  • Budget Oversight: Manage clinical development budgets and resources effectively, optimizing allocation to maximize return on investment.


Qualifications:


  • BS, MS or PhD in a relevant scientific discipline.
  • Minimum of 10 years of progressive experience in clinical development within the pharmaceutical or biotechnology (preferred) industry, with a proven track record of successful drug development.
  • Clinical experience should be through Phase 3, ideally including drug approval.
  • Strong leadership skills with experience managing and developing high-performance teams.
  • In-depth knowledge of clinical trial design, execution, and regulatory requirements.
  • Excellent communication and interpersonal skills, with the ability to influence and collaborate effectively across functions and levels.
  • Strategic mindset with the ability to anticipate challenges and drive innovative solutions.