Role: Chief Medical Officer (CMO)
Job location: Bangalore, India
Overview
The Head of Clinical Development will lead the overall clinical strategy and execution for oncology programs, from early clinical trials to late-stage development. The role will play a critical part in advancing Aurigene's pipeline of innovative cancer therapies and enabling global regulatory approvals.
Aurigene is a clinical-stage biotech with multiple oncology assets in global clinical development and strong partnerships with global pharma companies. This role is central to translating scientific innovation into successful clinical outcomes.
Key Responsibilities
Clinical Strategy & Leadership
- Define and drive the global clinical development strategy across oncology programs
- Lead clinical development from IND to late-stage trials (Phase I–III)
- Prioritize pipeline assets and ensure alignment with business and scientific goals
Clinical Execution
- Oversee design and execution of clinical trials globally (US, India, other regions)
- Ensure high-quality protocol design, patient safety, data integrity, and timelines
- Work closely with CROs, investigators, and partners
Regulatory & Compliance
- Lead interactions with global regulatory agencies (US FDA, DCGI, etc.)
- Oversee IND/NDA submissions and approvals
- Ensure compliance with global regulatory and ethical standards
Cross-functional Leadership
- Collaborate with discovery, translational research, pharmacology, PK, and toxicology teams
- Integrate clinical insights into overall drug development strategy
- Partner with business development for licensing and collaboration opportunities
External Engagement
- Build relationships with key opinion leaders (KOLs), investigators, and partners globally
- Represent the company in scientific forums, investor discussions, and regulatory meetings
Organizational Leadership
- Lead and build a high-performing clinical development team
- Strengthen capabilities in clinical operations, medical monitoring, and data review
- Drive a culture of innovation, speed, and scientific excellence.
Key Expectations / Success Metrics
- Progress multiple oncology assets through clinical milestones (IND, Phase I–III)
- Successful regulatory approvals and global trial execution
- Strong clinical data generation to support licensing and partnerships
- Build a scalable and globally competitive clinical development organization.
Qualifications & Experience
- MD with specialization in Oncology / Haematology (preferred)
- 18–25+ years of experience in clinical development in pharma/biotech
- Proven track record of:
- Leading IND filings and global clinical trials
- Supporting NDA/BLA submissions
- Working in both large pharma and biotech environments
- Experience in oncology drug development is essential
Key Skills
- Strong understanding of oncology clinical development and regulatory pathways
- Expertise in clinical trial design, data interpretation, and safety oversight
- Ability to work across the full drug development lifecycle
- Strong leadership and stakeholder management skills
- Experience in global collaborations and licensing deals
Why this role is critical
- Aurigene has a robust oncology pipeline with multiple clinical-stage assets
- The role directly impacts value creation through clinical success and partnerships
- Key to transitioning from clinical stage to commercial biotech
