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Fractional VP, Clinical Development (FVPCO)

The Vice President of Clinical Development will be responsible for leading and overseeing the clinical development strategy and operations of the organization. This position will play a critical role in driving the successful planning, execution, and management of clinical trials and research programs. The FVPCO will provide expertise in clinical development and regulatory affairs and be instrumental in advancing the organization’s pipeline and ensuring compliance with applicable regulations and standards.

Responsibilities:
  • Clinical Development Strategy: Develop and execute the organization’s clinical development strategy, aligning it with the overall business objectives and therapeutic area priorities. Drive the planning and implementation of clinical programs to support the organization’s product pipeline.
  • Clinical Trial Management: Oversee the planning, execution, and management of clinical trials, ensuring adherence to protocols, timelines, and budget. Collaborate with cross-functional teams to ensure the successful conduct of trials, including site selection, patient recruitment, data collection, and analysis.
  • Regulatory Compliance: Ensure compliance with applicable regulatory requirements, including FDA guidelines, ICH-GCP, and other relevant standards. Collaborate with regulatory affairs teams to prepare and submit regulatory documents, such as INDs, NDAs, and BLAs.
  • Clinical Operations: Provide leadership and guidance to the clinical operations team, ensuring effective resource allocation, performance management, and professional development. Foster a culture of collaboration, innovation, and continuous improvement.
  • Clinical Data Management: Oversee the collection, analysis, and interpretation of clinical trial data. Ensure the accuracy, integrity, and quality of clinical data, collaborating with biostatisticians and data management teams.
  • Risk Management: Identify and mitigate risks associated with clinical development activities, implementing effective risk management strategies and protocols. Monitor and address safety concerns and adverse events in collaboration with pharmacovigilance teams.
  • External Collaborations: Establish and maintain relationships with key external stakeholders, including clinical research organizations (CROs), academic institutions, and key opinion leaders. Collaborate on partnerships, collaborations, and investigator-initiated studies to support clinical development goals.
  • Budget and Resource Management: Develop and manage the clinical development budget, ensuring effective allocation of resources and cost control. Monitor and report on financial performance and resource utilization.
  • Scientific Leadership: Stay abreast of scientific advancements, industry trends, and regulatory changes in the field of clinical development. Provide scientific expertise and guidance to internal teams and external partners.
  • Cross-functional Collaboration: Collaborate with other departments, including regulatory affairs, medical affairs, and commercial teams to ensure alignment and integration of clinical development activities with broader organizational goals.

The specific responsibilities of a FVPCO will vary depending on the size and nature of your business. We will discuss in more detail at your FREE Business-People Assessment. 

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