Associate Medical Director/Medical Director, Early phase, Clinical Science

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Job Description

ACCOUNTABILITIES

 Lead or provide core clinical science support for Phase 1a/b and Phase 2a studies in Asia/China, including healthy volunteer. early patient trials, proof-of-concept studies, biomarker-driven studies,.
 Contribute to early phase clinical development plans, protocol synopses, and protocols, with specific input on patient population, endpoint selection, dose strategy, PK/PD sampling, biomarker
integration, and stopping rules.

 Provide medical and scientific oversight during study conduct, including review of eligibility questions, protocol deviations, emerging safety signals, and dose-escalation, dose-optimization, or
cohort-expansion decisions in collaboration with the study team.
 Interpret and communicate early clinical data, including safety, tolerability, PK, PD, biomarker, and preliminary efficacy results, to assess mechanism, establish early proof-of-concept, and support
timely development decisions.
 Work closely with global clinical science, clinical operations, biostatistics, translational medicine, pharmacovigilance, regulatory, and program leadership to ensure high-quality execution of early patient studies.
 Provide regional input on feasibility, investigator and site strategy, patient recruitment considerations, and operational planning for early phase patient studies in China and the broader Asia/China region.
 Support interactions with investigators, key opinion leaders, and regulatory authorities relevant to early phase patient development activities.
 Contribute to preparation of study reports, governance materials, and internal decision documents that enable progression from early patient studies through Phase 2a and beyond.

CORE ELEMENTS RELATED TO THIS ROLE

 Hands-on experience in healthy volunteer and patient-based early phase clinical development is required, with clear experience supporting or leading Phase 1 and Phase 2a trials in patients.
 Strong understanding of early phase patient study design and conduct, including dose selection, safety review, PK/PD interpretation, biomarker strategy, and early proof-of-concept evaluationin patients.
 Experience in immunology drug development is preferred; broad or general immunology background is highly desirable.
 Strong communication and matrix collaboration skills, with ability to work effectively acrossglobal and regional teams.

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

 Strong understanding of clinical development with direct experience in patient-based early phase pharmaceutical development, particularly Phase 1 and Phase 2a studies; prior immunology development experience is preferred, and broad general immunology experience is highly desirable.

Leadership

 Demonstrated ability to work across functions, regions and cultures
 Functional level leadership with the ability to inspire, motivate and drive results
 Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing
 Proven skills as an effective team player who can engender credibility and confidence within and outside the company
 Ability to distil complex issues and ideas down to simple comprehensible terms

 Demonstrates leadership presence and confidence
 Embraces and demonstrates a diversity and inclusion mindset and role models these
behaviors for the organization
 Builds teams across functions and geographies with individuals who have the right skills and
experience to deliver on key organizational initiatives.
 Invests time in helping others to enhance their skills and perform at a higher level

Decision-making and Autonomy

 Decision making responsibilities:
o Provide input to highly complex decisions that impact the functional area
o Accountable for decision-making for designated function
o Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions
o Ability to incorporate feedback and ensure decisions are implemented swiftly to yield flawless execution
 Accountable for providing input to and implementing vision and strategy for designated scope

Interaction

 Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace
 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
 Ability to build strong relationships and collaborate effectively with other interfacing Takeda functions

Innovation

 Forward thinking with the ability to recommend, influence and implement organizationalchange and continuous innovation
 Comfortable challenging the status quo and bringing forward innovative solutions
 Ability to take risks implementing innovative solutions, accelerating time to market
 Identifies opportunities and anticipates changes in the business landscape through anunderstanding and ongoing assessment of the environment affecting the business.
 Role models respect and inclusion, creating a culture that fosters innovation

Complexity

 Ability to work in a global ecosystem (internal and external) with a high degree of complexity
 Deep expertise required
 Ability to see and understand broader, enterprise level perspective

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS

 MD or internationally recognized equivalent, with substantial clinical practice and/or research experience. Advanced degree (PhD, or equivalent) in medicine, life sciences, or a related scientific discipline preferred.
 Direct experience in pharmaceutical development is required, with mandatory experience in patient-based early phase clinical trials, especially Phase 1 and Phase 2a.
 Experience in immunology drug development is preferred; candidates with broad or general immunology experience are strongly preferred.
 Ability to drive decision-making within multidisciplinary, multi-regional matrix teams and to integrate scientific, medical, and operational perspectives. Experience in MNC is preferred.
 Superior communication, strategic thinking, interpersonal, and stakeholder management skills.

 Health care business acumen with a sound understanding of the pharmaceutical industry and early clinical development environment.
 Fluent in English and Chinese

Locations

CHN - Beijing - Research and DevelopmentShanghai, China

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time