Clinical Development Strategist

hace 2 semanas

Madrid, Madrid, España STRAGO A tiempo completo
STRAGO Healthcare is a global consultancy that provides top-tier talent services to leading Healthcare and Life Sciences organizations worldwide.

We are seeking a highly experienced Principal Clinical Consultant to provide expert strategic advice on clinical and regulatory matters for global drug development projects.

Key Responsibilities:
  • Strategic Regulatory Guidance: Provide strategic regulatory advice and support to project teams, ensuring alignment with global regulatory requirements, timelines, and best practices.
  • Clinical Development Oversight: Oversee all clinical development activities, ensuring that clinical strategies are aligned with overall project goals and regulatory expectations.
  • Global Regulatory Planning: Develop and execute a comprehensive global regulatory plan, including submission timelines, regulatory milestones, and risk mitigation strategies.
  • Agency Interaction Leadership: Lead the development and implementation of the global agency interaction strategy, managing relationships with key regulatory bodies (e.g., FDA, EMA) and ensuring effective communication and submissions.
  • Cross-functional Collaboration: Collaborate with internal and external stakeholders, including clinical operations, medical affairs, regulatory affairs, and project management, to ensure cohesive execution of clinical development strategies.
  • Regulatory Submission Expertise: Drive the preparation, review, and submission of clinical documentation (e.g., IND, NDA, MAA) to regulatory agencies, ensuring accuracy and compliance with local and international guidelines.
  • Risk Management: Identify potential regulatory and clinical risks and develop proactive strategies to mitigate them throughout the drug development lifecycle.
  • Mentorship and Leadership: Provide leadership and mentoring to junior team members and other stakeholders involved in clinical and regulatory processes, fostering a culture of knowledge sharing and continuous improvement.
  • Stay Updated on Industry Trends: Monitor changes in global regulatory landscapes, assess their impact on current and future projects, and adjust strategies accordingly to maintain compliance and competitive advantage.
Qualifications:
  • Advanced degree (M.D., Ph.D., or Pharm.D.) in Life Sciences, Clinical Research, or a related field.
  • Minimum of 10+ years of experience in clinical development and global regulatory affairs, with a track record of successful regulatory submissions and approvals.
  • In-depth knowledge of regulatory processes and guidelines (FDA, EMA, ICH) and their application to clinical development.
  • Proven ability to develop and implement global regulatory strategies in complex clinical programs.
  • Strong leadership, communication, and interpersonal skills with a demonstrated ability to lead cross-functional teams.
  • Expertise in managing regulatory agency interactions and submissions.
  • Exceptional problem-solving skills and ability to manage risk in a highly regulated environment.
  • Strong organizational skills and the ability to manage multiple projects simultaneously.
  • Willingness to travel as needed.

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