Aurigene Oncology, a leading clinical-stage biotechnology company focused on conquering cancer through innovative NCEs, NBEs, and Cell & Gene Therapies, is actively hiring an experienced Medical Lead/Manager/Sr. Manager – Clinical Development for its Bangalore facility.
This is a rare opportunity to lead early-phase oncology and immune-oncology clinical programs in a Great Place to Work® Certified organization (Jun 2024–Jun 2025). If you have hands-on experience as a clinical development leader or medical monitor in IND, Phase 1, and Phase 2/PoC oncology trials, this role is tailored for you.
Key Responsibilities
- Act as clinical program leader on cross-functional project teams for oncology/immune-oncology programs
- Serve as clinical lead for Cell & Gene Therapy products (desired)
- Develop comprehensive clinical development plans, indication strategy, trial designs, and regulatory roadmaps
- Author high-quality clinical protocols, investigator brochures, IND/IMPD sections, and regulatory submissions
- Integrate translational research, clinical pharmacology, and pharmacokinetic data for efficient early clinical development
- Identify, evaluate, and contract global CROs/vendors; manage clinical trial budgets and timelines
- Drive go/no-go decisions, safety monitoring, DSMB interactions, and adverse event reporting
- Collaborate with preclinical, toxicology, CMC, regulatory, and translational teams
- Engage global KOLs and advisory boards for strategic clinical input
Desired Qualifications & Experience
- MBBS + MD (Clinical Pharmacology or relevant specialty) mandatory
- 2–5 years of clinical development experience in pharmaceutical/biotech or CRO environment
- Proven track record as clinical leader/medical monitor in IND, Phase 1, and Phase 2 oncology or immune-oncology trials (NCE/NBE)
- Experience in Cell & Gene Therapy clinical development highly desirable
- Strong knowledge of ICH-GCP, regulatory guidelines (DCGI, US FDA, EMA) for early clinical development
- Demonstrated expertise in authoring clinical documents and interacting with health authorities
- Excellent project management, vendor oversight, and matrix leadership skills
Benefits at Aurigene Oncology
- Work on cutting-edge oncology and Cell & Gene Therapy pipeline
- Collaborative and innovative culture with global exposure
- Competitive compensation and comprehensive benefits
- Certified Great Place to Work® with strong focus on diversity and inclusion
How to Apply
Interested candidates are requested to send their updated resume to: sushmitha@aurigene.com Subject line: Application – Medical Lead/Manager/Sr. Manager – Clinical Development
Early applications are encouraged as the position will be closed once filled.
FAQs
1. Is prior Cell & Gene Therapy experience mandatory? No, it is highly desirable but not mandatory. Strong experience in oncology/immune-oncology Phase 1–2 trials with NCE/NBE is the primary requirement.
2. What is the expected salary range for this role in Bangalore? The compensation is best-in-industry and typically ranges between ₹25–45 Lakhs per annum (total CTC) depending on experience and current compensation.
