Executive - Clinical Development

Why This Role Matters

Clinical Development is a critical bridge between vaccine research and public health impact. It ensures that vaccine candidates are scientifically evaluated, ethically tested, and clinically validated before reaching the market. Strong clinical research execution supports regulatory approvals and global health initiatives.
At Biological E. Limited, the Clinical Development professional in the Vaccines – R&D division plays a vital role in managing clinical research activities, identifying clinical sites, and supporting vaccine trial execution from planning to reporting.

Job Description

Biological E Limited is seeking experienced professionals for its Vaccines – R&D division at Jubilee Hills. The role involves supporting and managing clinical development activities for vaccine candidates, including clinical research coordination and clinical site identification.
The selected candidate will contribute to trial planning, site feasibility assessments, regulatory documentation, and coordination with CROs and investigators. This position offers exposure to vaccine clinical trials within a structured R&D environment.

Key Features of the Role

• Involvement in vaccine clinical trial planning and execution
• Exposure to regulatory and ethics submission processes
• Clinical site identification and feasibility assessment
• Coordination with investigators, CROs, and regulatory bodies
• Opportunity to work in vaccine R&D ecosystem
• Career progression within Clinical Development function

Responsibilities

• Support clinical trial planning and protocol implementation
• Identify and evaluate potential clinical trial sites
• Conduct site feasibility assessments and documentation
• Coordinate with investigators and clinical research teams
• Assist in preparation and submission of regulatory documents
• Monitor clinical study timelines and deliverables
• Ensure compliance with GCP and regulatory guidelines
• Maintain clinical trial documentation and tracking systems
• Support data review and query resolution processes
• Participate in cross-functional meetings with QA, Regulatory, and R&D teams

Required Qualifications

• 2 to 9 years of experience in Clinical Research or Clinical Development
• Experience in clinical site identification and feasibility analysis
• Strong understanding of ICH-GCP guidelines
• Exposure to regulatory submission processes preferred
• Experience in vaccine or biologics clinical trials is an advantage

Educational Requirements

• M.Sc (Life Sciences / Biotechnology preferred)
• Master of Pharmacy

Experience and Skills

• Strong knowledge of clinical trial processes
• Experience in coordinating multi-site studies
• Good documentation and regulatory understanding
• Excellent communication and stakeholder coordination skills
• Ability to manage timelines and deliverables
• Familiarity with clinical trial management systems preferred
• Analytical thinking and problem-solving capability

Salary Insights

• Compensation aligned with experience and designation level
• Competitive industry standards for mid-level clinical roles
• Exposure to vaccine R&D programs
• Structured career progression within Clinical Development

Location Details

Department: Vaccines – R&D
Function: Clinical Development
Location: Jubilee Hills, Hyderabad

Company Overview

Biological E. Limited is a leading Indian biopharmaceutical organization known for vaccine innovation and life-saving biologics. The company has a strong presence in global immunization programs and operates advanced R&D and manufacturing facilities.
The Vaccines – R&D division focuses on developing and clinically validating vaccine candidates that meet international quality and regulatory standards.

FAQs

Q: Is prior vaccine experience mandatory?
Vaccine or biologics experience is preferred but not mandatory.

Q: Will this role involve site visits?
Yes, clinical site identification and feasibility assessments may require site interaction.

Q: What determines Executive vs. Manager level?
Experience depth, independent trial handling capability, and regulatory exposure determine designation.

Q: Is GCP knowledge required?
Yes, understanding of ICH-GCP guidelines is essential.

Application Tips

• Highlight clinical trials handled and therapeutic areas
• Mention site identification and feasibility experience
• Include regulatory submission exposure
• Quantify number of sites or studies managed
• Showcase GCP training and certifications