Clinical Science Specialist

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Job Description

OBJECTIVES : 

• Responsible for development and execution of clinical research protocols across all therapeutic areas
• As a clinical trial physician for individual studies is responsible for ensuring patient safety , high quality data and compliance to internal and external quality standards including local laws and regulations
• Collaborate with therapy medical team to assess and validate the clinical evidence gap and develop the high quality manuscript aligned with the overall product strategy  
• Partner with the clinical operations team in ensuring smooth execution of clinical operational strategy

ACCOUNTABILITIES: 

• Preparation and review of high quality clinical trial synopses and protocols
• Prepare and review medical oversight plans and perform Medical Oversight of assigned clinical studies, in collaboration with medical affairs physicians.
• Coordinate and lead internal multidisciplinary teams to drive critical research program decisions. This includes working in alignment with regulatory, PV, clinical operations and DM.
• Leads meetings and negotiations with key external investigators and incorporates their advice and recommendations into the design of clinical studies and programs.
• Review and interpret data generated from clinical studies and assess the impact of study outcome on the overall compound strategy in collaboration with therapy medical team
• In collaboration with therapy medical team prepare a  strategic publications plan and author high quality publications
• Provide direction to the clinical operations team , ensuring compliance to internal procedures and applicable regulatory guidelines for clinical study conduct
• Reviews and assesses overall study safety information in conjunction with Pharmacovigilance team
• Review clinical dossiers submissions to regulatory agency
• Lead and participates in regulatory meetings for Clinical Trial Protocol applications , ensuring smooth approval of all application.
• Act as a subject matter expert to support Medical Affairs training on study protocol including medical monitoring and publication processes
• Support Clinical Operations Lead and Medical affairs in providing scientific input on clinical strategy and feasibility of global clinical trials for India LOC.
• Active member of various Takeda committees and task forces which define the processes for developing and implementing Global Takeda standards that are used in clinical development, post-marketing surveillance process in order to promote the consistency of data throughout the Takeda group companies.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: 

• M.B.BS/ MD candidates with 5-7 years of clinical research experience within the pharmaceutical industry.
• Previous experience as a CTP for multiple studies and therapeutic areas preferred.
• Excellent knowledge of cGxPs, quality standards and industry best practices
• Good knowledge and understanding of the pharmaceutical industry, local clinical trial regulations and understanding of ICH E6, ICH E3, ICH E8, ICH E9
• Superior communication, strategic, interpersonal and negotiating skills
• Ability to proactively predict issues and solve problems
• Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams
• Diplomacy and positive influencing abilities

TRAVEL REQUIREMENTS:

• Domestic travel may be required (20-30%), including some weekend commitments.
• Limited international travel (10-20%) may be required.

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