China Asia Program Lead – Early Phase, R&D, Shanghai

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Objective / Purpose:
The China Asia Program Lead Early Phase (e-CAPL) is a scientific and clinical leader within Development accountable for leading the China Asia Clinical Development Team Early Phase (e-CADT) advancing early-phase assets through FIH to early proof of concept (ePOC) and signal seeking studies of clinical stage assets. Guided by Takedas values and commitment to Patient-Trust-Reputation (PTR) this role ensures that early clinical development decisions are grounded in strong science patient focus and ethical standards.
In close partnership with Global Program Leads and cross-functional stakeholders the e-CAPL shapes and executes China-specific early development strategies aligned with global objectives. The role contributes critical clinical translational and scientific insights to enterprise portfolio decision-making enabling timely high-quality go/no-go decisions and maximizing the probability of success for early pipeline assets.

Accountabilities: Describe the primary duties and responsibilities of the job. Include only the essential functions of the job. Approximately 5 10 bulleted task statements should be identified.
Strategic Planning and Execution
Lead the e-CADT with a values-based leadership approach fostering a culture of scientific excellence accountability inclusion and continuous learning.
Define and execute China/Asia early clinical development strategies from first-in-human through ePOC ensuring alignment with global development plans and Takedas enterprise priorities.
Provide scientific and clinical leadership for the design execution and interpretation of early-phase and signal-seeking clinical trials including Phase I and exploratory Phase II studies.

Job Description
Champion patient-centric trial design and ethical decision-making ensuring patient safety and data integrity are prioritized at all times.
Drive strong cross-functional collaboration across Clinical science Clinical Operation Clinical Pharmacology Biomarkers Statistics Regulatory and other partners to enable integrated development strategies.
Act as the China early development subject-matter expert in global governance forums influencing development strategy and key portfolio decisions with local insights clarity and credibility.
Proactively identify scientific clinical and operational risks demonstrating courage and ownership in addressing challenges driving solutions and balancing speed quality and value creation in line with Takedas long-term vision.
Build trusted relationships with investigators key opinion leaders and external partners to support innovative early clinical research in China.
Communicate program strategy progress risks and results clearly to senior leadership and global stakeholders.
Fiscal Responsibility
Responsible for project operating budgets within the regional program activities; monitor and control expenditures; manages variance between budgeted and actual expenditures of time dollars and personnel while meeting overall Takeda financial objectives.
Resource and Issue Management
Manages internal and external resources (people information technologies time and capital); allocates project resources appropriately given regional function and individual goals and objectives to align with business imperatives.
Proactively identifies project issues before they arise and develops contingency plans; communicates project-related issues to senior executive management and manages issues to resolution.
Consults with GPLs and Senior Management in R&D China and APAC region to deliver accurate and timely project status and deliverable information to enable the organization to focus on key priorities and enhance its ability to deliver work on-time and on-budget.
Change Management
Proactively responds to the dynamics of a changing marketplace; directs adjustments in functional or cross-divisional plans in response to changes in strategic direction.
Contributes to the creation and maintenance of systems/databases for the purpose of tracking key performance indicators (KPIs) trending learning and improving decisions regarding program performance and continuance.

Matrix Team Management
Provides matrix management strategic and tactical leadership to eCADT members who are responsible for leading the key deliverables or cross-functional teams within individual projects.
Education & Competencies (Technical and Behavioral): List the essential and desirable education and competency requirements to perform the primary responsibilities of the job. Any minimum requirements should be noted.

CORE ELEMENTS RELATED TO THIS ROLE:
This position will lead and manage a matrix team of people and resources to take the accountability and achieve high levels of performance and improve the overall performance of early phase China clinical program activities. Program activities include planning towards milestones defining clear go/no go decision points managing critical path activities proactively identifying issues resolving conflicts and communicating project-related issues to senior executive management.

EDUCATION BEHAVIOURAL COMPETENCIES AND SKILLS:
Education
Bachelors degree in science or business-related field
Advanced degree (MD PhD or equivalent) in medicine life sciences or a related scientific discipline.
Experience
Minimum of 12 years of experience in pharmaceutical or biotechnology research and development with significant hands-on leadership in early clinical development.
Minimum 8 years experience with increasingly complex pharmaceutical projects in a multi-disciplinary global / regional environment including strategy development and execution
Minimum of 5 years matrix team management in a global / regional matrix team environment
Proven track record leading assets from IND/first-in-human through early proof of concept including signal-seeking and hypothesis-driven studies.
Strong experience working in complex global matrix environments with accountability for cross-functional and cross-regional outcomes.
Demonstrated people-management experience including building developing and inspiring high-performing early clinical development teams.
Demonstrated ability to clearly and concisely communicate with and prepare presentations for Senior Management and Executives
Broad business orientation is highly preferred

Managed multiple submissions and approvals
Experience in autoimmune and/or immunology therapeutic areas is strongly preferred.
Knowledge and Skills:
Deep scientific expertise in early clinical development including clinical pharmacology translational science biomarker strategy and early efficacy assessment.
Expert knowledge in the overall pharmaceutical drug development process from discovery through post-marketing
Strong understanding of immunology and autoimmune disease biology with the ability to translate scientific insights into clear clinical development strategies.
Thorough knowledge of early-phase drug development and clinical trial regulations in China with an appreciation of global regulatory expectations and standards.
Strong strategic thinking and analytical skills enabling sound judgment and high-quality decision-making under uncertainty.
Experience with project leadership and management systems and methodology to support consistency across multiple projects
Clear concise and credible communication skills with the ability to engage scientific clinical and executive audiences. Ability to express oneself clearly and concisely to external partners vendors or with others within the team; ability to message key issues appropriately and document issues and/or concerns concisely and comprehensively; ability to adjust language and/or terminology appropriate for the audience; Demonstrated ability to clearly and concisely communicate/present key information to senior management
High personal integrity accountability and resilience with a demonstrated commitment to Takedas values and long-term mission.
Demonstrated ability to build consensus and drive resolution of issues while maintaining positive working relationships across functions negotiation and strong persuasive abilities
Strategic Implementation: ability to develop implement and monitor the overall project strategy in China and integrate this strategy with GPT goals
Leadership Skills: develop and use knowledge and interpersonal skills to influence and guide others towards the accomplishment of Takedas goals and objectives. Requires flexibility and tolerance to best manage change and different opinions with diplomacy and competence
Ability to drive decision-making within a cross-functional cross-country and cross-cultural global team structure and requires global mindset and cultural awareness in working with senior leadership in other regions and in managing cross-regional projects
Demonstrated ability to lead through influence in a matrix organization building alignment and trust across diverse stakeholders (One Takeda mindset).
Knowledgeable in budget and finance processes appropriate to the pharmaceutical industry
Ability to adapt to other personalities in a respectful manner that is conducive to goal achievement
Ability to capture knowledge within the cross-functional cross-country; improve solutions processes and deliverables through use of information; improve information capital by contributing experience theories deliverables and models for others to use
Management of multiple tasks of varied complexity simultaneously
Ability to work in a stressful and demanding environment with aggressive project timelines
Fluency in English; proficiency in Mandarin strongly preferred.

LICENSES/CERTIFICATIONS
Project Management Professional certification from PMI desired.
TRAVEL REQUIREMENTS
May travel domestically and internationally.
Approximately 20% travel is required.