Consultant - Clinical Development
Glenmark Pharmaceuticals · India
Part-time · Mid-Senior level · Posted 1 month ago
Role Overview:
As a Consultant, you will serve as a clinical and scientific subject matter expert, providing hands‑on medical oversight and strategic leadership across oncology development programs. You will play a critical role in ensuring patient safety, data integrity, and scientifically sound decision‑making throughout the clinical trial lifecycle.
Key Responsibilities:
Act as the Oncology SME for early and late‑phase oncology clinical trials, supporting patient safety oversight.
Provide expert input into oncology trial design, protocol development, eligibility criteria, endpoints, and dose‑modification guidelines.
In Oncology trials, review and assess serious adverse events (SAEs), adverse events of special interest, and safety signals, providing timely medical guidance.
Partner closely with Clinical Operations, Regulatory Affairs, Medical Affairs, Pharmacovigilance, and Biostatistics to support study execution and regulatory readiness.
Interpret emerging efficacy and safety data, literature, and competitor insights to inform development strategy and risk‑benefit assessments.
Contribute to Data Monitoring Committees (DMCs), safety review meetings, investigator interactions, and regulatory responses.
Drive a patient‑centric, evidence‑based approach, ensuring oncology best practices are embedded across all development programs.
Qualification:
MD (Oncology)
Experience:
2 + years of prior experience in managing oncology trials
Location:
Remote/Hybrid