Medical Strategy Manager

2 weeks ago

Ahmedabad, Gujarat, India beBeeClinicalAffairs Full time ₹ 2,06,40,000 - ₹ 2,61,70,000

Job Title

The Clinical Affairs Lead oversees the strategic planning, execution, and oversight of clinical research and evaluation activities. This role ensures that clinical evidence supports product safety, efficacy, and regulatory compliance.

Key Responsibilities:
  • Strategic Leadership
    • Define 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 according to 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.
    • Ensure timely and compliant execution of Investigator Initiated Studies (IIS) and Post-Market Clinical Follow-up (PMCF) studies.
    • 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.
    • Ensure scientific rigor and regulatory compliance in all clinical documentation.
    • 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.
    • Prepare for and support regulatory inspections and audits.
    • Develop and maintain SOPs, work instructions, and clinical policies.
    • Monitor global regulatory changes and assess impact on clinical operations.
  • Stakeholder Engagement
    • Enable scientifically accurate marketing collateral creation with the marketing and sales teams.
    • Build and maintain relationships with Key Opinion Leaders (KOLs), academic institutions, and clinical partners.
    • Organize advisory boards, investigator meetings, and scientific forums.
    • Deliver scientific presentations and training to internal teams and external stakeholders.
  • 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.
    • Manage departmental resources and timelines to ensure studies are completed as planned.
    • Promote cross-functional collaboration and knowledge sharing.

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