Clinical Operations Leader

4 weeks ago

Hyderabad, Telangana, India Dr Reddy's Laboratories Limited Full time
Job Title: Clinical Operations Leader

About the Role:
Dr. Reddy's Laboratories Limited is seeking a highly skilled Clinical Operations Leader to drive global clinical operations, biopharmaceutics, biostatistics, and data management. The ideal candidate will have a strong background in clinical development and experience in leading cross-functional teams.

Key Responsibilities:
  • Design and implement a robust clinical operation strategy and review study protocols across various business regions to facilitate product approval.
  • Provide guidance and oversight to the team, ensuring comprehensive clinical strategies and seamless collaboration with product vertical leaders.
  • Lead clinical operations of study/sponsor oversight of CRO by team including site selection, initiation, monitoring, and close-out as well as review of visit reports.
  • Supervise end-to-end patient study activities, clinical operations, resolve complex issues to ensure generation of quality clinical data for product approval as per the stipulated timelines.
  • Review and ensure development/vendor oversight of study documents e.g. IB, Protocol, CRF, ICD, patient diary etc., as applicable and study plans e.g. project management plan, clinical monitoring plan, medical monitoring plan, safety management plan, IMP management plan, risk management plan, data management plan, statistical analytical plan etc., as applicable.
  • Provide accurate cost & timelines for the provided clinical development strategy and guide team for country where the provided Clinical Development Program can be implemented effectively.
  • Identify, develop, leverage, and manage global network of Clinical Research Organisation with the objective of delivering strategic bio-studies and high bio-success to have better control on cost and timelines for bio-studies.
  • Provide guidance to data management team on data management plans, quality output, and robust bio-statistics framework with inputs on SAP (statistical assessment plan).
  • Develop the next level of leaders by enabling opportunities for development. Actively participate in performance management, recruitment, development, and succession planning activities for Clinical Management function to ensure clinical excellence within the organisation.
  • Ensure capability building to interface with internal and external centres of excellence in areas of bio-studies, including academic institutions, subject matter experts, and key opinion leaders.
  • Ensure compliance to GCP, SOPs, scientific principles, and applicable regulations.

Requirements:
  • MD/Ph.D (Medicine/Pharmacology), M Pharm
  • Minimum 15 years of experience in clinical development for New drug products and Complex Generics.
  • Excellent communication and interpersonal skills.
  • Strong analytical and problem-solving abilities.
  • Good negotiation and influencing skills.
  • Ability to work collaboratively with Regulatory and cross-functional teams.

About Dr. Reddy's Laboratories Limited:
Dr. Reddy's Laboratories Limited is a science-driven, innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We integrate our deep science capabilities and cutting-edge technology to develop innovative, accessible, and affordable therapies for patients worldwide. We have end-to-end capabilities in API, Formulations, Clinical, Intellectual Property, and Regulatory Affairs. We are serving 55+ markets including USA, Canada, Europe, China, LATAM, ASEAN, and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API), Oral formulations, Parenteral (Injectables, Ophthalmics) & Other dosages. Our product development efforts drive a portfolio of more than 1,000 products enabled by our robust R&D team consisting of more than 200 scientists and functional experts and more than 150 doctorates. We have filed 1,071 patents and also published over 1,000 papers for peer review over the years.

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