Company Overview
Role Purpose
Academic Stream
Work experience (in months)
Job Responsibility and key Decisions
Head the manufacturing team and supervise manufacturing activities as per the plans in leadership capacity.
Foster a compliant quality culture in the entire cGMP operations.
Prepare and monitor the annual departmental revenue budget for Opex and Capex requirements.
Approve the production plan in coordination with planning department.
Ensure effective utilization of resources in the plant.
Liaise with relevant support functions QA QC Warehouse Maintenance EHS HR to trouble shoot.
Operational issues as needed, to achieve the production targets.
Review and approve production related documentations as needed.
Identify implement continuous improvement opportunities in plant operations.
Mentor and Coach direct reports.
Facilitate training development of plant personnel.Clinical Finance Management
Oversee clinical program budgets, forecasts, and financial tracking across global studies.
Approve vendor contracts, CRO budgets, and site payments in alignment with financial governance.
Monitor financial performance and implement costcontrol strategies without compromising quality.
Clinical Supply Management
Lead planning and distribution of investigational products and clinical supplies across global sites.
Ensure supply chain compliance with regulatory standards and trial timelines.
Collaborate with manufacturing and logistics teams to optimize inventory and reduce waste.
Clinical Trial Management
Direct the execution of Phase IIV clinical trials, ensuring adherence to protocols, timelines, and quality standards.
Oversee site selection, initiation, monitoring, and closeout activities.
Resolve operational challenges and escalate risks to senior leadership with mitigation strategies.
Clinical Data Management
Provide oversight for data collection, validation, and database lock activities.
Ensure data quality and integrity through collaboration with biostatistics and data management teams.
Support integration of digital tools and eClinical platforms to enhance data efficiency.
CrossFunctional Collaboration
Partner with Regulatory Affairs, Medical Affairs, Pharmacovigilance, and Quality to ensure seamless trial execution.
Represent Clinical Operations in governance boards and strategic planning forums.
Align operational goals with clinical development milestones and corporate objectives.
Team Leadership Development
Lead and mentor clinical operations professionals across finance, supply, trial, and data functions.
Build highperforming teams through training, coaching, and succession planning.
Foster a culture of accountability, innovation, and continuous improvement.