Vopec Pharmaceuticals Private Limited

JOB DESCRIPTION Key Responsibilities: Clinical Trial Planning: Develop and execute comprehensive clinical trial plans, protocols, and study timelines in compliance with all relevant regulatory guidelines (e.g., ICH-GCP, FDA regulations). Site Management: Identify, qualify, and manage clinical trial sites and investigators. Ensure proper site initiation, monitoring, and closure. Study Oversight: Supervise all aspects of the Phase II clinical trials, including patient recruitment, data collection, and case report form (CRF) completion. Budget & Vendor Management: Manage trial budgets and timelines. Oversee and coordinate activities of contract research organizations (CROs) and other third-party vendors. Quality Assurance: Implement and maintain quality control processes to ensure data integrity and adherence to the study protocol. Regulatory Compliance: Prepare and submit necessary documentation to regulatory authorities and ethics committees. Address any queries or requests from regulatory bodies. Team Leadership: Lead and mentor a team of clinical research associates (CRAs) and other support staff to ensure efficient trial execution. Problem-Solving: Proactively identify potential issues and risks and develop effective mitigation strategies. Preferred Candidate Profile We are looking for a skilled professional with a proven track record of success in clinical trial management. The ideal candidate will possess: Experience: A minimum of 10-12 years of experience in managing clinical trials, with significant experience in Phase II and Phase III trials. Education: A Bachelor's or Master's degree in a life science, health science, or a related field. A doctoral degree (Ph.D., Pharm.D., M.D.) is a plus. Expertise: In-depth knowledge of the drug development process and strong familiarity with oncology is highly desirable. Regulatory Knowledge: Comprehensive understanding of Good Clinical Practice (GCP) guidelines, ICH regulations, and local regulatory requirements. Skills: Exceptional project management, communication, and interpersonal skills. Must be a strategic thinker with a keen eye for detail. Leadership: Demonstrated leadership ability with experience managing teams and external vendors. Role & responsibilities Key Result Areas (KRAs) The performance of the Manager of Clinical Trials will be measured against the following Key Result Areas: Trial Initiation & Timeline Adherence: Achieve timely initiation of all three Phase II clinical trials (Oral, Lung, and Pancreatic Cancer) within the planned timelines. Patient Recruitment: Meet and exceed patient enrolment targets for each indication to ensure statistical power and timely data analysis. Budget Management: Ensure clinical trial expenditures remain within the approved budget by effectively managing resources and vendor contracts. Data Integrity & Quality: Maintain a high level of data quality and integrity, as evidenced by a low rate of protocol deviations and clean database lock. Regulatory Submissions: Achieve successful and on-time submission of all required regulatory documents and obtain timely approvals from regulatory bodies. Team Performance: Foster a high-performing team environment, resulting in the successful achievement of project milestones and objectives. About Vopec Vopec Pharmaceuticals Private Limited: Pioneering Cancer Therapeutics Join Vopec Pharmaceuticals, a Chennai-based clinical-stage biotech driving innovation in oncology. Our lead program, AB001, is a next-generation small-molecule immunotherapy targeting PD-L1 and multiple cancer pathways, with US FDA Orphan Drug Designations for pancreatic cancer, glioblastoma multiforme, and acute myeloid leukemia. Following strong Phase 1 safety and efficacy results, we are now advancing into Phase 2 trials for oral, lung, and pancreatic cancersoffering a rare opportunity to work on a globally significant, first-in-class cancer therapeutic. As we expand our clinical development program, we are seeking a talented and driven Manager of Clinical Trials to lead the execution of our Phase II studies for AB001 across three critical indications: Oral Cancer, Lung Cancer, and Pancreatic Cancer. This is an incredible opportunity to join a passionate team at the ground floor of an innovative oncology program and make a tangible difference in the lives of patients worldwide. Visit : https://www.vopecpharma.com/drug-development Contact : Mrs.Chitra Group Head HR Vopec Pharmaceuticals Pvt Ltd, B-13, Mogappair Industrial Estate, Mogappair West, Chennai - 600 037. INDIA grouphr@vopecpharma.com Mob : 95000 77040