Director/Senior Director of Clinical Biomarker Development

Reports to Head of Clinical Development/Chief Medical Officer

Position based in Shanghai/Beijing


Position Summary:

This position leads Bioanalytical, Biomarkers and Companion Diagnostics effort and reports into Clinical Development. The primary responsibilities of this position are to act as a central point of contact between the Biomarker Analysis group, the clinical development teams and CROs.  He/She will direct clinical biomarker validation and development strategy, sourcing and outsourcing of clinical biomarker assay development and validation; provide biomarker and specialized diagnostic testing support for China, and China-led MRCT clinical trials in all phases of development. This position requires a significant understanding of the biomarker validation, development and biomarker guided clinical trial designs and operations.


Key Responsibilities:

· Collaborate with functional groups to develop and implement biomarker strategies, plans and components with the support from external CROs to enable filing and implementation of all-stage biomarker guided China clinical trials.

· Evaluate, interpret and present complex scientific data to KOLs and regulatory authorities.

· Collaborate with clinical and pre-clinical teams to identify, evaluate biomarker vendors and CROs and provide oversight of biomarker development program management.  Provide input on biomarker related sections of clinical study protocols including the necessary sample collection, processing and shipping requirements. Collaborates with Clinical Operations to ensure compliance related to biomarker-related sample collection and evaluation.

· Direct and manage the implementation of overall biomarker/companion diagnosis development involving in-house non-clinical, clinical team, hospitals and KOLs.



· Master Degree or above in biological sciences or related field with 10 or more years of related experience.

· Experienced in oncology drug development highly preferred.

· Must have at least 10 years industry experience in fit-for-purpose clinical assay development, validation and implementation in support of multisite clinical trials. China implementation experience is highly desirable.

· Must have experience overseeing the establishment of biomarker assays at CROs.

· A strong preference for a candidate with broad technical. Candidates with flow cytometry and molecular pathology (IHC, ISH) flow cytometry a plus.

· Ability to work independently as well as collaboratively in a matrixed team environment.

· Strong oral/written and interpersonal skills required.

· Ability to adjust priorities in a fast-paced environment.

· Strong organizational and networking skills.

· Strong oral/written English skills.



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