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.
Description:
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.
