Clinical strategy and innovation team member

Job Description

Job Description 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 Qualifications MBBS/MD with 5+ years of experience in clinical strategy and innovation Additional Information Having clinical operations experience will be helpful Show more Show less