Research Leader

6 days ago

Bhavnagar, Gujarat, India beBeeClinical Full time ₹ 20,00,000 - ₹ 25,00,000
Clinical Research Director

This position oversees the strategic direction of clinical research and evaluation activities for a medical device portfolio. The Clinical Research Director is responsible for planning, executing, and overseeing all clinical research and evaluation activities.

Key Responsibilities:

  • Strategic Leadership
    • Develop and implement clinical strategies aligned with product development and regulatory pathways.
    • Lead the creation 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 site selection, qualification, and monitoring of investigational sites.
    • Lead interactions with CROs, investigators, and ethics committees.
    • Review and approve Clinical Study Reports (CSRs) and ensure publication of key findings.
  • Clinical Evaluation & Documentation
    • Supervise the creation of Clinical Evaluation Reports (CERs) and literature reviews.
    • Maintain up-to-date knowledge of MEDDEV 2.7/1 Rev. 4 and EU MDR requirements.
    • Support risk management through clinical data analysis and hazard identification.
  • Regulatory & Compliance
    • Ensure all clinical activities comply with national and international regulations (CDSCO, FDA, EU MDR).
    • Prepare for and support regulatory inspections and audits.
  • Stakeholder Engagement
    • Enable creation of scientifically accurate marketing collateral with the marketing and sales teams.
    • Build and maintain relationships with Key Opinion Leaders (KOLs), academic institutions, and clinical partners.
  • Team Leadership & Development
    • Build, lead, and mentor the Clinical Affairs team, fostering a culture of scientific excellence and compliance.
    • Define departmental goals, KPIs, and training plans.

Qualifications & Experience:

  • A degree in Medicine, Pharmacy, Life Sciences, or Biomedical Engineering (MD, PhD, or equivalent preferred).
  • At least 12 years of experience in clinical research within the medical device or pharmaceutical industry.
  • Proven leadership in clinical trial management and regulatory compliance.

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