Clinical Development Scientist - Vaccine Business

Biological E; Hyderabad; Sur place; INR 1 800 000 - 2 400 000; Plein temps

Résumé du poste

Biological E is seeking a Clinical Development Scientist in its Vaccines R&D Clinical Development division. The role involves supporting the Head of Clinical Development in shaping vaccine clinical programs, including protocol design, trial conduct and data interpretation.

The candidate should have a PhD/MBBS/MD with at least 2 years of experience in clinical development, with vaccine experience preferred. Jubilee Hills location, Hyderabad, India.

Qualifications

• PhD/MBBS/MD with minimum 2 years of experience in clinical development.
• Vaccine experience preferable.
• Interest in vaccine industry.

Responsabilités

• Support the Head - Clinical Development in strategizing clinical development of investigational vaccines to move into early phase trials.
• Provide input and/or support theHead in design, planning, initiation and completion of clinical trials.
• Coordinate with Preclinical, CMC/Quality and Clinical teams regarding product development.
• Prepare study protocols, Clinical dossiers and other regulatory submissions including publications.
• Assist in execution of assigned clinical trials and programs with medical, statistical and trial management teams.
• Attend scientific meetings to stay updated and represent the project/company externally.

Connaissances

Clinical development

Vaccine industry interest

Formation

PhD/MBBS/MD

Description du poste

Function / Department

R&D Clinical Development

Position Title / Role

Clinical Development Scientist

Qualification & Experience

PhD / MBBS, MD with minimum 2 experience,

Vaccine experience is preferable.

Unit / Location

Jubilee Hills

Division

Vaccines R&D Clinical Development

Main purpose of the Job:

To provide inputs and/or assist the Head Clinical Development in development of clinical programs across indications involving vaccine candidates. Provide inputs to all aspects of product development including, synopsis and protocol design, conduct of clinical trials, implementation and monitoring; as well as data interpretation and reporting.

Job Responsibilities:

• Support the Head - Clinical Development in Strategizing Clinical Development of investigational vaccines to move into early phase of clinical trials
• Provides input and/or support the Head in the design, planning, initiation and completion of clinical trials.
• Coordinate with Preclinical, CMC/Quality and Clinical teams with respect to product development
• Responsible for the preparation of study protocols, Clinical dossiers and other regulatory submissions including publications.
• Assist in the execution of the assigned clinical trial and/or clinical program in partnership with other line functions including medical associates, statisticians, trial managers where applicable.
• Attend appropriate scientific meetings to maintain awareness of research activities and represents a project and/or Company at such external events.

Preferred candidate profile

• Having Ph.D. in Immunology.
• Interested working in Vaccine Industry
• Minimum 2- 5 Years of Exp in Clinical Development, R&D
• Preparing essential clinical trial documentation, distributing, tracking and filing of documents on return.