Clinical strategy and innovation team member

• To Provide medical opinion and clinical strategy for a new 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

MBBS/MD with 10+ years of experience in clinical strategy and innovation

Having clinical operations experience will be helpful