China Clinical Lead(oncology)

YOUR TASKS AND RESPONSIBILITIES:

As the clinical leader assigned to the project(s), the incumbent will be responsible to drive the design, execution and delivery of the clinical development plan in collaboration with other cross-functional team members.

The incumbent is responsible for developing drugs safely and effectively:

Translates Target Product Profile into clinical strategy;

Responsible for study medical/safety aspects and risk-benefit assessments; supported by PV and CDS

Assesses and ensures validity of efficacy data

Interprets medical data to identify possible patient safety and data integrity issues; is primary contact for study medical and patient safety aspects

Leads and manages relationships withkey internal/external stakeholders (eg Study Team, KOLs, health authorities)

Responsible for medical section of protocol, trains internal/external stakeholders (eg Study Team, Site Staff) and performs the protocol review during the site initiation visit

Ensures Clinical Study Report (CSR) medical content adheres to acceptable medical standards

Individual may be representing the team to other decision/governance meetings, senior management or advisory boards as applicable

May be responsible for supervising/mentoring multiple studies/clinicians

WHO YOU ARE:

MD(or equivalent) required; PhD in addition strongly preferred

Specialized experience in Oncology strongly preferred

Board certified inOncology strongly preferred

Ideal candidate will have experience in several of the following areas:

Experience in exploratory clinical drug development specific to Oncology

Experience in the drug development and commercialization process

Understanding of the complexities and recent developments in the oncology

Understanding of issues related to the design and performance of technologically demanding trials

Confident to discuss scientific/mechanistic aspects of drug development

Familiar with the regulatory and legal environment

Strong communication skills (fluent in English both written and spoken) to ensure that project plans and status are transparent; risks, issues and results are clear to all involved parties

High level of comfort/success working in a matrix environment (global/multi-cultural/cross-functional). This includes contributing to a trust environment: clarity, collaboration and results oriented

Demonstrated leadership skills both as an individual contributor or team leader

Networking and alliance management

3+ years of applicable experience/education; limited supervision; small-medium size projects increasing in complexity

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