Regional Medical Director, Vaccine

**OBJECTIVES**:

- Support regional (geographical) vaccine development colleagues with clinically related guidance to clinical operations, Medical Affairs and commercial.
- Create, maintain, and support the collaboration of global development plans in the assigned region
- Serve as key contributor to clinical documents, including clinical development plans, clinical trial documents, reports and publications and integrated clinical documents for regulatory submissions, as well as external presentations.
- Serve as clinical contact point for ongoing partner projects and build/maintain strong working relationships between Takeda and stakeholders.

**ACCOUNTABILITIES**:
**Clinical Development**
- Ensure that the regional/country medical needs and practices are considered when reviewing/advising on global clinical development plans.
- Work in a matrix team with other colleagues, to ensure that development teams are proactively identifying regional specific contingencies and potential risks and leverage regional strategies to address/ development or lifecycle challenges.
- Support the Development Strategy, Clinical Development Plan and Clinical trial protocol design, clinical study reports and publications
- Advise regional decision making: monitoring and interpreting data from internal and external studies/reports/publications, assessing the clinical and scientific implications and making recommendations that impact regional development. Consider how a given product will fit in with current treatments, standard of care, and unmet medical needs.
- Co-lead in the country and site/investigator selection process.
- Co-lead in site feasibility assessment at regional and country level
- Provide clinical input in regional/local study documents and regional submission and overall clinical advice to Delivery Operations group.
- Oversee medical monitoring activities in accordance with current Medical/Clinical Oversight SOP guidance.
- Support in managing critical issues linked to the investigator and his/her team.
- Support the initiation, set-up, oversight and reporting of country specific Phase IV trials.
- In collaboration with the Development Operations Group, support the set-up and clinical oversight of post marketing commitment trials.

**Global Medical Affairs**
- Provide scientific & clinical support within cross-functional team(s) to implement local strategies as well as bridging regional and global scientific/medical alignment
- In coordination with Medical Affairs, support/advise Medical Affairs’ regional network of KOLs needed for advising and supporting the adequate development of Takeda’s vaccines in the region.
- Support the development of publications and presentation on updated clinical information at local/regional congresses, maintain and communicate up to date information on local/regional publication.
- Review and advise on Investigators’ Initiated Studies in the assigned region

**Regulatory Affairs**
- Attendance and participation in meetings with regulatory authorities/agencies in the assigned region/countries as appropriate.

**Risk Management**
- Provide continual critical evaluation of the clinical development strategy in the assigned region to ensure that it is consistent with the latest regulatory and clinical guidelines requirements, proactively identify challenges, and develop contingency plans to meet them.

**Leadership, Task Force Participation, Upper Management Accountability**
- Interact directly with specific divisions based on pertinent clinical and development expertise to provide knowledge/understanding of regional market environment
- Is an advocate of Takeda’s values internally and externally.
- As appropriate mentors, motivate, empower, develop, and retain staff to support assigned activities.

**EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS**:

- Medical Degree and 3 years of clinical research experience within the Vaccines industry or CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned).
- Previous experience successfully leading a clinical development team with responsibility for studies/activities in multiple regions.
- Experience and demonstrated ability to manage highly trained medical, scientific and technical professionals preferred.

**Skills**
- 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 across multinational business cultures

**Knowledge**
- Vaccines, immunology, infectious diseases, public health
- Regional/country medical and regulatory requirements and practices
- GCP/ICH and Emerging research in designated therapeutic area

**Locations**:
Singapore, Singapore

**Worker Type**:
Employee

**Worker Sub-Type**:
Regular

**Time Type**:
Full time