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Job Description

Takeda has been translating science into breakthrough medicines for 240 years. Every step of the way, our teams have worked together to tackle some of the most challenging problems in drug discovery and development. Today, we’re a driving force behind innovative therapies that make a lasting difference to millions of patients around the world.

OBJECTIVES/PURPOSE

Direct and drive the implementation of regional compliance management related to quality events and internal audits for clinical trial delivery functions including the identification and development of applicable processes and toolsEstablish and lead proactive risk-based compliance assessments for regional clinical trial activities and ensure completion of robust CAPA/EC-related compliance assessmentsDevelop and report to leadership on key performance indicators and mitigation strategies for regional clinical trial delivery activitiesProvide regional expertise for program and study level GCP inspection readiness and inspection preparation strategies including process adherence, inspection-risk management, TMF oversight and proactive study team preparedness for audits and inspections

ACCOUNTABILITIES

Compliance Management

Oversee and manage regional quality events/deviations including root cause analysis, CAPA development and implementation, effectiveness check tracking, and non-compliance reportingFacilitate regional and/or participate in Global clinical trial delivery internal audits with study teams and functional areas including but not limited to: study team preparation, facilitating audit requests, managing audit responses and CAPA development and implementation. Partner with Quality Assurance to ensure appropriate audit scopes and clinical trial delivery participation.Lead regional activities for clinical trial functional areas and study teams on issues related to GCP compliance and liaise with study execution teams on compliance to clinical trial delivery procedures and developing effective mitigation and escalation strategiesParticipate in GCP Excellence in Clinical Trials strategies to incorporate regional considerations to enable clinical trial functional areas and study teams to embed inspection readiness and process adherence into ways of working. Participate as a regional expert in Global activities with R&D Quality and GCP Compliance Management to develop GCP inspection strategy in support of submission planning and routine inspectionsPartner with Quality Assurance to ensure appropriate audit scopes and clinical trial delivery participation for regional activities; providing regular status updates to appropriate stakeholders and leadershipServe as an expert in TMF process and participate in strategy and implementation of risk-based TMF oversight strategies for study execution teams to incorporate regional considerations. May serve as inspectorate facing TMF subject matter expert for regulatory inspections of Takeda

Compliance Assessments

Proactively identify process/therapeutic area/project risks and develop/lead assessments to assess complianceAdvise process owners and functional areas on the development and implementation of effective mitigation and escalation strategies for projects including regional considerations to address risks and issuesDevelop, lead and oversee regional and/or global compliance assessments to address GCP Quality Plan, CAPAs/ECs and liaise with QA to ensure adherence to the pla

GCP Compliance Metrics and Reporting

Engage and build relationships with clinical trial delivery functions, R&D QA, and other stakeholders on performance metrics, analytics and reporting for GCP compliance activitiesIdentify, develop, and track KPIs, metrics and dashboards to track process quality and compliance

Other

Responsible for training, coaching and mentoring supervised employees (direct and indirect reports) to create a culture that attracts, retains and develops innovative thinkersAct as role model for Takeda’s values

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

Thorough knowledge of pharmaceutical industry and deep understanding of drug development from research through commercializationStrong understanding of global and local regulations within the regionExperience in leading global teamsSufficient knowledge of communication tools including online meeting and virtual meeting platforms to optimize communication and information exchange in a global environment

Leadership

Demonstrated ability to work across functions, regions and culturesExcellent communicator, able to persuasively convey both ideas and data, verbally and in writingProven skills as an effective team player who can engender credibility and confidence within and outside the companyAbility to distill complex issues and ideas down to simple comprehensible termsEmbraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization

Decision-making and Autonomy

Broad decision making responsibilities:

Ability to make complex decisionsAbility to develop solutions to complex issues and challengesAccountable for decision making for designated functionAbility to incorporate feedback and ensure decisions are made swiftly

Interaction

Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplaceAbility to build strong partnerships and drive role clarity with other interfacing Takeda functions

Innovation

Comfortable challenging the status quo and bringing forward innovative solutions

Complexity

Ability to work in a global ecosystem (internal and external) with a high degree of complexityBreadth of knowledge required across therapeutic areas, indications, and/or modalities

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: 

Bachelor’s Degree or international equivalent required; Life Sciences preferred8+ years' experience in the pharmaceutical industry and/or clinical research organization, including 6+ years in compliance or clinical study managementExperience in leading projects and coordinating collaboration with cross-functional teamsStrong strategic thinking, planning, execution, and communication skillsGlobal/international experience required, including ability to collaborate with colleagues and staff in other locationsOperational experience in clinical development with significant direct exposure to implementation of novel approaches in clinical developmentHealth care business acumen with a comprehensive understanding of the pharmaceutical industry

LocationsIND - Bengaluru

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time