Teams at Zydus Therapeutics Inc.

Lead operational execution and oversight of in-house and outsourced clinical trials (Phase I-III). Manage CRAs and CROs, drive start-up through close-out, ensure ICH-GCP compliance, RBM and SDV monitoring, TMF/eTMF completeness, inspection readiness, risk mitigation, and cross-functional collaboration. Provide coaching, governance, KPI tracking, and regulatory inspection support.

Lead national and federal payer account strategies to secure coverage and reimbursement for Zydus Therapeutics products. Build executive-level relationships with PBMs, payers, VA/DoD, and state agencies; develop account plans, negotiate contracts, coordinate cross-functional implementation, address coverage issues, and support commercial launch activities for rare/specialty oral therapies.

Manage all site monitoring activities (SQV, SIV, PMV, COV) per ICH/GCP; act as primary site contact, train site staff, ensure safety reporting, protocol compliance, IP and supply management, assist recruitment, oversee eTMF and documentation, escalate and remediate noncompliance.