Dr. Reddy's - Lead - Medical Operations

Lead Medical Operations

Description:

Lead Medical Ops for medical oversight of global clinical studies

Lead - Medical Operations

The position will be responsible for ensuring complete medical inputs to, and oversight of all clinical studies being conducted for all Dr.Reddys Biologics products under development.

Location: Biologics, Dr Reddy's Laboratories Limited, Bachupally, Hyderabad

Education & Experience: MBBS/MD with experience in clinical research field in Bio pharmaceutical industry, preferably in Therapeutic Proteins/Biosimilars with 8 - 13 yrs of experience.

Responsibilities:

Medical Monitoring and Drug Safety:

- Safety management and medical monitoring of clinical trials

- Preparation/review of safety monitoring and medical monitoring plan

- Impart therapeutic area and Protocol training to internal and external teams as required

- Address and manage all medical queries related to the molecule in development, and the protocol related queries - both from internal and external stakeholders, including but not limited to patient eligibility criteria, protocol compliance and AE /SAE medical management.

- Review and inputs to various clinical study documents including but not limited to, Investigators Brochure, Clinical study protocol, ICD, Clinical study report.

- Review of regulatory submission documents such as Executive summaries/ dossiers, and compilation of appropriate (clinical) sections, as required.

- Active lead/participation/presentations for DSMB Meetings, NDAC meetings, Therapeutic Area Expert meetings, Therapeutic Area Advisory meetings, Ad board Meetings, as per organizational requirements

- Co-ordination and partnering with external partners (CRO/ alliance) to ensure best safety interests of the clinical trial subjects.

- Work closely with internal stakeholders - both within and outside the functional domain, and with the external partners to ensure timely and quality deliverables, and streamlined functioning of the projects as needed.

- Any other responsibility, as delegated by Head Medical Sciences

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