Chief Medical Officer

About the Role

We are seeking an experienced, proactive, and strategically minded Chief medical officer with solid Phase I/ II clinical trial expertise & regulatory expertise to drive the operational delivery of clinical studies while providing expert guidance on global regulatory requirements. This unique cross-functional role ensures seamless coordination between clinical operations and regulatory affairs, enabling efficient study execution, high-quality data generation, and timely regulatory submissions.

You will play a key leadership role in shaping clinical strategy, guiding study teams, engaging with regulatory authorities, and ensuring full compliance across all trial phases. About 20% travel is also anticipated.

Position: Chief medical officer

Employment Type: Full-time

Location: (Hyderabad, Bangalore, Chennai or any major city including hybrid/remote)

Department: Clinical Development / Clinical Operations & Regulatory Affairs

Key Responsibilities

Clinical Trial Leadership
• Lead the end-to-end operational planning and execution of clinical trials (Phases I–IV).
• Develop and manage study timelines, budgets, operational plans, and risk mitigation strategies .
• Oversee site selection, activation, enrollment performance, and study delivery.
• Serve as the primary operational contact for internal teams, CROs, and external investigators.
• Ensure TMF completeness , high-quality data, and audit/inspection readiness.

Regulatory Expertise & Oversight
• Provide strategic input for regulatory pathways , submissions, and health authority interactions (CDSCO, DCGI, FDA, EMA).
• Prepare, review, and coordinate regulatory documents including:
• Clinical Trial Applications (CTAs)
• IND/IMPD submissions
• Responses to authority questions
• Amendments and safety reports
• Monitor evolving regulatory guidelines and assess their impact on ongoing and planned studies.
• Support interactions with global regulatory authorities (e.g., FDA, EMA, Swissmedic).

Cross-functional Collaboration
• Partner with Clinical Development, Medical Affairs, Safety, Biometrics, and Quality teams.
• Guide and mentor CRAs, study coordinators, and operational team members.
• Ensure alignment between operational execution and regulatory strategy.

Quality & Compliance
• Ensure adherence to ICH‑GCP, global regulations, SOPs , and ethical standards.
• Oversee risk assessments, CAPAs, and quality improvement initiatives.
• Support internal and external audits and regulatory inspections.

Qualifications
• Any medical degree and allied degrees (MD, MD PhD, MBBS, PhD in Life Sciences, Pharmacy, Nursing, or related field; with advanced clinical trial course certification and/or industry experience is desirable.
• 3–10 years of experience in clinical trials / clinical research experience with proven trial leadership responsibilities.
• Understanding of oncology, haemato-oncology, regenerative medicine or RNA biology would be an asset.
• Strong and demonstrable regulatory affairs experience , particularly with CTAs, INDs/IMPDs, and interactions with regulatory authorities.
• Deep understanding of ICH‑GCP , DCGI, CDSCO, FDA and other regional regulatory guidelines.
• Proven leadership in a matrix environment and experience managing cross-functional teams.
• Exceptional communication, stakeholder management, and problem‑solving skills.
• Ability to manage multiple priorities in a dynamic environment.
• Experience with clinical systems (EDC, CTMS, eTMF) is an asset.

What We Offer
• Competitive compensation and benefits. Starting at 25 lac Rs/annum.
• Opportunity to lead high-impact clinical programs
• A dynamic, collaborative, and innovative work culture
• Flexible/hybrid working arrangements

Professional development and career growth opportunities