Chief Medical Officer (CMO)
Role Overview - The Chief Medical Officer (CMO) is the medical and clinical strategy leader of our client, responsible for translating its exosome therapeutics, biomaterial-enabled tissue engineering platforms,and organoid-based disease models into safe, effective, and regulator approved clinical products.
The CMO owns clinical development strategy, patient safety, regulatory credibility, and clinical data-driven decision-making, ensuring that every program is scientifically sound, ethically conducted, and commercially relevant.
Key Responsibilities
Clinical & Translational Leadership
- Define and lead the clinical development strategy across all platforms of our client.
- Translate organoid and preclinical data into clinically meaningful trial designs, endpoints, and patient populations.
- Establish clinical milestones and Go / No-Go decision gates from preclinical through late-stage trials.
Clinical Trial Design & Governance
- Serve as the medical owner of all clinical trials, including protocol design, endpoints, and risk–benefit assessments.
- Oversee patient safety, adverse event review, and protocol amendments.
- Chair or contribute to Data Safety Monitoring Boards (DSMBs) and internal clinical review committees.
Clinical Data Interpretation & Decision Support
- Act as the chief medical interpreter of clinical and translational data.
- Provide leadership with clear, unbiased assessments of safety, efficacy, and clinical relevance.
- Guide program advancement, redesign, or termination based on data quality and medical value.
Regulatory & Compliance Leadership
- Lead regulatory strategy with CDSCO, ICMR, FDA, EMA, and ethics committees.
- Oversee INDs, clinical trial applications, safety reports, and regulatory submissions.
- Ensure compliance with GCP, GLP, and global clinical research standards.
External & Strategic Leadership
- Represent our client with regulators, investigators, KOLs, and partners.
- Support fundraising, partnerships, and licensing discussions by articulating clinical value and risk.
Qualifications Required
- MD / MBBS with specialization in Internal Medicine, Surgery, Transplant Medicine, Regenerative Medicine, Immunology, or related fields.
- 10+ years in clinical development in biologics, cell therapy, regenerative medicine, or advanced therapeutics.
- Experience advancing programs from preclinical to human trials.
Preferred
- Experience with exosomes, organoids, biomaterials, or tissue engineering.
- Familiarity with Indian and global regulatory pathways.
- Background in biotech startups or translational research.
Core Competencies
- Strong clinical judgment and scientific depth
- Data-driven decision-making
- Regulatory and ethical leadership
- Ability to bridge science, medicine, and business
- Unwavering commitment to patient safety
share resume at [Confidential Information] or WhatsApp at 8929700006
