Lead Clinical sciences Fresher's job
1 year ago Medical & Healthcare Hyderabad 81 views Reference: 29148Job Details
Job Description
Purpose :
To:Support in developing the Clinical Development Strategy, Design Clinical Development Plan (CDP) and Clinical Trial Outlines (CTO), obtain Target regulatory agency buy-in, support clinical operations and medical sciences teams for seamless execution on clinical strategy; contributes to the analysis of the results and its projection in regulatory documents and publications, Perform due-diligence (Medical/ Clinical) for in-licensing deals.
| Within: Clinical Sciences/ Clinical strategy | ||||||||
| With the objective of : Enhancing business value by providing the most efficient Clinical development plan and individual clinical studies for biosimilar drugs at Biologics |
| Clinical Development Plan |
| Based on regulatory needs and business objectives and the Target Product Profile (TPP), prepare/ support preparation of Clinical Development Plan (CDP) and Clinical Trial Outlines (CTOs) for individual clincial trials (including data from literature on comparable clinical trials; product safety data and regulatory data on expectations and requirements to secure approvals). Support preparation of Briefing book for target agency submission and obtain target agency buy-in for CDP and CTOs. Support clinical protocol, CSR and BLA modules preparation Ensure adequate provision for data generation during course of studies to arrive at logical data sets facilitating regulatory approvals; IN ORDER TO Devise the Clinical Development Plan and the Clinical Trial Outlines, towards obtaining registration of DRL Biologics Projects in target markets |
| Support at different stages of clinical trials |
| Provide inputs to clinical operations & medical sciences team and partners on aspects such as- analysis accuracy and completeness of data as per plan; review trial data reports vis-à-vis design; Interpret and own (eventually drive) root cause analysis in situations of indeterminate outcomes during clinical study IN ORDER TO help Medical Sciences and Clinical Operations deliver on intended Clinical Trial Outcomes |
| Research and Competitive Intelligence |
| Research regulatory, scientific, clinical practice, stakeholder perspective regularly to stay abreast of trends; identify sources that can be tapped; in case of issues use this data for resolving issues; analyse reports and communicate key points to all relevant stakeholders to enable decisions; attend clinical conferences and participate in seminars as applicable IN ORDER TO help evolve competitive clinical development strategies |
| Publication/ Communication |
| Work with medical sciences on the contents of publication, presentation and strategic elements of positioning the data; review the analysed data going to the regulatory team and further to publication in order to leverage data and reduce the differences that a regulator may observe IN ORDER TO position clinical data for securing approvals and achieving business goals |
Company Description
We are committed to providing access to affordable and innovative medicines, driven by our purpose of Good Health Cant Wait.Our products and services are spread across our core businesses of Active Pharmaceutical Ingredients (API), generics, branded generics, biosimilars and over-the-counter pharmaceutical products around the world. We work towards meeting unmet patients needs in the areas of gastro-enterology, cardiovascular, diabetology, oncology, pain management and dermatology. We are investing in businesses of the future including drug discovery, clinically-differentiated assets and digital healthcare.
