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 prospects 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