Job Description

- To Provide medical opinion and clinical strategy for a current project to be introduced in to Emerging markets (China, Brazil, Russia & Japan) with respect to preclinical/clinical studies required, cost timelines and market risk associated with proposed projects
- Preparation of clinical study synopsis for the various phases of clinical development to seek study budget from clinical operations team/CROs
- Coordinating to get study cost and timelines from the preclinical and clinical operations SPOC
- Review inputs on the newer ideations or differentiation proposals from medical perspective including the current unmet need, scope for drug differentiation & any pipeline activity on the proposal
- To provide clinical strategy for seeking certificate of pharmaceutical products (COPP) from CDSCO for registration of product in India
- To provide detailed medical evaluation of products with respect to competing treatment landscape and place in therapy area & any unmet medical need in the therapy area




- Support with scientific write-up for seeking scientific advice and controlled correspondence for various regulatory agencies
- Regulatory deficiency management: response to regulatory deficiencies/queries
- Functional due diligence of BD opportunities and in licensing dossier: assess if clinical development of due diligence products is in line with regulatory requirement. Provide detailed clinical evaluation and recommendation for products
- Responding to medical queries from cross functional teams i.e., preclinical, FR&D;, portfolio etc.
- Review inputs on briefing books & clinical modules wherever applicable
- Propose a newer ideation or differentiation of already existing drug products basis of the existing unmet medical need

Qualifications

MBBS/MD with 5+ years of experience in clinical strategy and innovation

Additional Information

Having clinical operations experience will be helpful

📌 Clinical strategy and innovation team member (Hyderabad)
🏢 Recognized
📍 Hyderabad