Clinical Affairs Lead

4 weeks ago

Bhavnagar, Gujarat, India Zydus Group Full time
Position - Lead - Clinicals Affairs

Company: Zydus Medtech Pvt Ltd

Reporting: Zydus Medtech Head

Location: Ahmedabad

Key Responsibilities

The Lead of Clinical Affairs will lead the strategic planning, execution, and oversight of all clinical research and evaluation activities across Zydus Medtech's medical device portfolio. This role ensures that clinical evidence supports product safety, efficacy, and regulatory compliance, while enabling innovation and market access. The position reports to the BU Head and collaborates closely with Regulatory Affairs, R&D, and Marketing teams.

1. 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

2. Clinical Research & Investigations

- Oversee the design, planning, and execution of clinical trials in accordance with ISO 14155, GCP guidelines and ethical norms
- Undertake end-to-end management of trials including single-arm studies with other relevant teams like regulatory, marketing etc.
- 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

3. 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

4. Regulatory & Compliance

- Ensure all clinical activities comply with national and international regulations (CDSCO, FDA, EU MDR)
- 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

5. 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
- Organize advisory boards, investigator meetings, and scientific forums
- Deliver scientific presentations and training to internal teams and external stakeholders

6. 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 budgets, undertake resource planning and timeline management to ensure studies are completed as per plan
- Promote cross-functional collaboration and knowledge sharing

Qualifications & Experience:

- Advanced degree in Medicine, Pharmacy, Life Sciences, or Biomedical Engineering (MD, PhD, or equivalent preferred)
- Minimum 12 years of experience in clinical research within the medical device or pharmaceutical industry
- 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
- Proficiency in Microsoft Office and clinical trial management systems

Preferred Skills:

- Experience with digital health technologies and real-world evidence generation
- Familiarity with electronic data capture (EDC) systems and clinical databases
- Certified Clinical Research Professional (CCRP) or equivalent
- Experience in global clinical trial execution and multi-center studies

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