Clinical Development Manager

Department:

Clinical Development

Educational Qualifications:

PhD with Immunology or Pharmacology with 10-18 years experience, Vaccine/Immunology industry experience is preferable

Responsibilities:

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

2. Support the Clinical Development Strategy Lead in Strategizing Clinical Development of investigational vaccines to move into early phase of clinical trials

3. Provides input and/or support the Head in the design, planning, initiation and completion of clinical trials.

4. Coordinate with Preclinical, CMC/Quality and Clinical teams with respect to product development

5. Drive 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.

6. Attends appropriate scientific meetings to maintain awareness of research activities and represents a project and/or Company at such external events.

7. Responsible for the preparation of study protocols and other regulatory submissions.

8. Review medical data of ongoing trials to ensure accuracy, and compliance with the protocol and to iden

9. Monitor safety data of ongoing trials to ensure accuracy, compliance with protocol and to identify early safety signals.