Clinical Affairs Director

1 day ago

Ahmedabad, Gujarat, India beBeeDirector Full time ₹ 15,00,000 - ₹ 20,00,000

Job Title: Clinical Affairs Director

About the Role

We are seeking an experienced and strategic Clinical Affairs Director to lead our clinical research and evaluation activities. This is a critical role that requires a deep understanding of regulatory requirements, clinical trial management, and leadership skills.

Key Responsibilities:
  • Develop and implement clinical strategies aligned with product development and regulatory pathways
  • Lead the development of clinical evaluation plans (CEPs) and clinical investigation strategies
  • Ensure alignment of clinical claims with regulatory and commercial objectives
  • Represent Clinical Affairs in cross-functional leadership meetings and strategic planning sessions

Clinical Research & Investigations

  • Oversee the design, planning, and execution of clinical trials in accordance with ISO 14155, GCP guidelines and ethical norms
  • Manage protocol development, database management and study execution
  • Manage site selection, qualification, and monitoring of investigational sites
  • Lead interactions with CROs, investigators, and ethics committees

Clinical Evaluation & Documentation

  • Supervise the creation of Clinical Evaluation Reports (CERs) and literature reviews
  • Ensure scientific rigor and regulatory compliance in all clinical documentation

Regulatory & Compliance

  • Ensure all clinical activities comply with national and international regulations (CDSCO, FDA, EU MDR)
  • Prepare for and support regulatory inspections and audits

Team Leadership & Development

  • Build, lead and mentor the Clinical Affairs team, fostering a culture of scientific excellence and compliance

Requirements

Education: Advanced degree in Medicine, Pharmacy, Life Sciences, or Biomedical Engineering

Experience: Minimum 12 years of experience in clinical research within the medical device or pharmaceutical industry

Skills: Proven leadership in clinical trial management and regulatory compliance, Strong understanding of ISO 14155, GCP, EU MDR, and FDA regulations, Experience with CERs, PMCF, and clinical strategy development, Excellent communication, negotiation, and stakeholder management skills

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