
Associate Director, Clinical Program Management
Bengaluru, Karnataka- Job Type: Full Time
- Job Level: Senior
- Travel: Minimal (if any)
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.
In R&D, all of our history and potential comes together in an environment that welcomes diversity of thought and amplifies every voice. Working closely with colleagues, you’ll play a key role in bringing our rich pipeline of products forward to help patients. Come join a team that’s earned trust for more than two centuries, and find out how advancing transformative therapies at Takeda will shape your bright future.
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
OBJECTIVES/PURPOSE
- Lead study operational strategy and planning and oversee execution of clinical studies for the assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan (CDP).
- In close collaboration with Clinical Operations Program Lead (COPL) and Clinical Study Manager (CSM):
- Responsible for oversight of the execution of studies in the assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget.
- Oversight of strategic CRO partners and/or other vendors to meet Takeda’s obligations described in ICH-GCP and Takeda’s business objectives.
- Represent Clinical Operations to contribute to CDP by providing regional operational expertise and strategic, inputs including study feasibility, budget, and timeline for assigned clinical programs
ACCOUNTABILITIES
- Accountable for developing regional operational strategy for assigned clinical studies.
- Contribute to the translation of CDP into an optimal operational strategy and plan. Lead assessment of various scenarios operational for optimal execution of CDP.
- Collaborate with key investigators to reflect feasible and realistic operational inputs to CDP and ensure timeline and quality of studies meet the needs of CDP.
- Provide subject matter expertise and operational input into protocol synopsis and protocol, obtaining opinions in terms of study execution from key investigators, as appropriate.
- Challenge study team to ensure that operational feasibility, inclusive of patient and site burden and that timelines meet the needs of CDP.
- Validate budget and ensure impacts are adequately addressed.
- Participate in site selection process, with a focus on providing country insights, and therapeutic expertise to ensure alignment between study execution plan and program strategy.
- Responsible for clinical study budget planning and management, and accountable for external spending related to clinical study execution. Works closely with relevant stakeholders (strategic CRO partners, other vendors, CSM, COPL, and Program Management, Outsourcing, and Finance) to ensure the accuracy of budget spending on a regular basis.
- Oversee strategic CRO partners and other vendors to ensure the overall operational execution and delivery of the assigned clinical studies in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget. Oversight includes but is not limited to:
- Review and approval of key risk-based monitoring documents/plans, periodic review of outputs, decisions, and actions related to risk-based monitoring.
- Documented review and monitoring of issues, risks and, decisions at the study level.
- Support the identification of trends across sites and/or the study.
- Review and provide clinical operations expertise into clinical documents related to the drug development process:
- Creation and maintenance of clinical trial materials, such as Investigator Brochures, study synopsis & protocols, clinical study reports, etc.
- Preparation of key regulatory meetings, as appropriate.
- Collaborate with cross-functional counterparts and strategic CRO partners/other vendors to ensure inspection readiness and lead Clinical Operations aspects of inspection readiness activities and act as subject matter expert during regulatory inspections.
- Actively seek new ways of working more efficiently to meet the needs of clinical development, such as cost-reduction, time-savings, efficiency, and quality.
- Participate in Business Development/in-licensing/alliances evaluations by providing operational due diligence.
- Responsible for talent development, including training and mentoring less experienced staff.
- Seek an efficient way to maximize operational excellence in the cross-regional collaboration (e.g. Japan & Asia) with innovative ideas.
CORE ELEMENTS RELATED TO THIS ROLE
Program
- Provide operational expertise and strategic inputs to the development of CDP and lead assessment of various operational scenarios for optimal execution of CDP.
- Recognized as a clinical operations expert by other functions and stakeholders across R&D.
Organization
- Actively seek new ways of executing studies more efficiently to meet the needs of clinical development and encourage the function.
Capability development
- In addition to the self-development, think about supporting the development of Clinical Operations staff by sharing knowledge and experience with them.
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
- Have sufficient knowledge of regulatory and compliance requirements and guidance for clinical development, assigned Therapeutic Areas (TAs), project governances, and working models and accurately assess the impact of these on the assigned TA and programs.
Leadership
- Demonstrate ability to work across functions, regions, and cultures.
- Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization.
- Train and develop less experienced staff with an awareness of mid- to long-term function goals and clinical development.
Interaction
- Cultivates a broad network of relationships throughout Takeda, with affiliates and external partners, in the industry and area of expertise.
- Effectively represents function in negotiations with the ability to resolve conflict in a constructive manner.
Innovation
- Recommend and influence the ideal model and approach for meeting the program goals and TA operational strategies.
- Challenge status quo and bring forward innovative solutions.
Complexity
- Work in global ecosystem (internal and external) with a high degree of complexity.
Decision-making and Autonomy
- Provide input and implement appropriate strategies with understanding the goals of the function and assigned TA.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelor’s Degree or international equivalent required, Life Sciences preferred.
- Innovate and challenge peers and teams to think and work differently; Work independently, excel at solving issues without the need for support, but is effective at enlisting support for specific asks when necessary.
- Participate and lead clinical operations in cross-functional initiatives and workstreams that affect clinical operations; Adapt ways of working to the function’s current state and formulate strategic plans to work within the existing framework.
- Capable of assessing gaps cross-functionally and can take a supportive role in leading changes that benefits the function as it related to clinical trial execution and study management.
- Encourage and provide input, suggestions, and support for competency building within the organization.
- Demonstrated excellence in study management, including scenario assessment, risk assessment and contingency planning.
- Excellent teamwork, communication, organizational, interpersonal, conflict resolution and problem-solving skills.
- Talent development skills to enhance capabilities.
- Experience of 10+ years in pharmaceutical industry and/or clinical research organization, including 7+ years of clinical study management/oversight.
- Experience must include Phase 1, 2, 3 studies and global/international studies or programs.
- Experience in more than one therapeutic area.
- English (fluently in oral and written communication)
- Local language (fluently, a native level)
TRAVEL REQUIREMENTS:
- Requires approximately 5-20 % travel, including overnight and local/international travel to other Takeda sites, strategic partners, and therapeutic area required travel.
Locations
IND - BengaluruWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeThe heart of our work
Shining a light on new perspectives
Working at Takeda
-
Inclusion
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team. -
Collaboration
A strong, borderless team, we strive together towards our priorities and inspiring mission. -
Innovation
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients. -
Top Workplace
Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2025. -
Work-Life
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family. -
Empowerment
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
We're Steadfast In Our Commitment to Four Key Imperatives
Patient
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
People
Create an exceptional people experience.
Planet
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
Jobs for you
- Key Account Manager Ho Chi Minh City, Vietnam Category: Sales
- Key Account Executive - Dong Nai Ho Chi Minh City, Vietnam, Remote Category: Sales
- Associate Director, Clinical Program Management Bengaluru, India Category: Clinical Development
- Global Pricing Lead, GI-Inflammation Zurich, Switzerland Category: Market Access
