Clinical Trial Manager

COMPANY PROFILE

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 cancers—offering 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.

https://www.vopecpharma.com/drug-development

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.

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.

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.

Visit : https://www.vopecpharma.com/drug-development

Contact :

Mr.BA Reddy

President

Vopec Pharmaceuticals Pvt Ltd,

B-13, Mogappair Industrial Estate,

Mogappair West,

Chennai - 600 037. INDIA

bareddy@vopecpharma.com

Mobile : 98404 88261