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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.
Locations
IND - Remote LocationWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full time#LI-Remote
