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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.
Locations
IND - Remote Location
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time #LI-Remote
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