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Clinical strategy and innovation team member

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Job Description - Clinical strategy and innovation team member

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

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