Key Accountabilities
•To deliver robust clinical strategies and trial execution for NCEs globally.
•To ensure compliance with international and local regulatory standards.
•To provide leadership in clinical decision-making and cross-functional collaboration.
•To drive timely completion of clinical milestones to support regulatory filings.
Clinical Development Strategy
• Define and lead global clinical development strategies for NCEs, ensuring alignment with regulatory pathways and business objectives.
•Provide scientific and strategic input for clinical trial design, endpoints, and overall development plans.
Clinical Trial Oversight
•Oversee planning and execution of Phase I–IV clinical trials, including protocol development, site selection, and operational delivery.
•Ensure trials meet timelines, budget, and quality standards while maintaining patient safety and data integrity.
Regulatory & Compliance
•Collaborate with Regulatory Affairs for IND/NDA submissions and respond to health authority queries.
•Ensure adherence to ICH-GCP, local regulations, and ethical standards across all clinical activities.
Cross-functional Collaboration
•Partner with R&D, Medical Affairs, Pharmacovigilance, and Commercial teams to integrate clinical insights into product development and lifecycle management.
•Provide clinical expertise for labelling, risk management, and market access strategies.
Vendor & Stakeholder Management
•Manage relationships with CROs, investigators, and external partners to ensure high-quality trial execution.
•Negotiate contracts and monitor vendor performance for compliance and efficiency.
Leadership & Team Development
•Build and mentor a strong clinical team, fostering innovation and operational excellence.
•Drive organizational capability in clinical research through training and best practices.
Education & Experience:
• Minimum 18–20 years of progressive experience in clinical development within the pharmaceutical or biotech industry.
• Proven track record of leading global clinical programs for New Chemical Entities (NCEs), including Phase I–IV trials.
• Strong experience in strategic planning and execution of clinical development plans aligned with regulatory requirements.
• Hands-on experience in liaison with regulatory authorities (CDSCO, USFDA, EMA) and supporting IND/NDA submissions.
• Demonstrated expertise in vendor/CRO management, clinical operations, and risk mitigation strategies.
• Exposure to global markets and multi-country clinical trial management.
• Leadership experience in building and mentoring large clinical teams and driving cross-functional collaboration.
Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
Amneal (NASDAQ: AMRX) is rapidly becoming one of the most dynamic, purpose-driven pharmaceutical companies delivering more affordable access to essential medicines. Our family delivers for yours through a robust U.S. generics business, a growing branded business and deepening portfolios in injectables, biosimilars and select international markets. We’ve bolstered our world-class scientific rigor, production capabilities and commercial infrastructure. And we invest substantially in our people through leadership development and employee well-being programs – all so we can deliver even more value. We are Amneal and We make healthy possible.
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