"Alerted.org

We are seeking a highly experienced Executive Director with a strong background in Clinical Biomarker Science for Oncology (Solid Tumor Portfolio) to join our team. In this role, you will lead a group of clinical biomarker scientists located in both China and US and be responsible for overseeing the development and implementation of clinical biomarker strategies for some of our solid tumor oncology programs, as well as, developing and implementing innovative biomarker strategies to advance our clinical trials.

The candidate will also contribute significantly to our clinical development efforts as core member of our research governance committees, participate as a member of our clinical biomarker and CDx leadership team as well as our Translational Medicine Leadership team. The incumbent will be expected to provide scientific input for translational and clinical biomarker strategies across our pipeline as well as drive technological innovation for our early portfolio. As our portfolio matures, the incumbent may be asked to lead one of our disease franchises.

Key Responsibilities:

+ Help establish best practices for clinical biomarker development in collaboration with our stakeholders in discovery and development.

+ Develop and mentor junior biomarker scientists.

+ Guide the development and implementation ofglobalclinicalbiomarkerstrategiesforouroncology programs.

+ Workcloselywithcross-functionalteamstodesignandexecutebiomarker- driven clinical trials.

+ Manageandoverseeexternalcollaborationswithacademicinstitutions, contractresearchorganizations,andotherpartnersinthefieldofbiomarker discovery.

+ Guidethedevelopmentandvalidationofbiomarkerassaysforclinicaluse, includingproficiencytesting,analyticalvalidation,andclinicalvalidation.

+ Establishandoverseequalitycontrolproceduresrelatedtobiomarker analysis.

+ Guide the analysis of clinicalbiomarkerdatato informclinicaldecision-making.

+ Communicatebiomarkerdatatointernalstakeholders,externalpartners, and regulatory authorities.

+ Participateinthepreparationofregulatorysubmissionsrelatedto biomarkersforoncologyandimmuno-therapyprograms.

+ Lead high-impact clinical and biomarker publications in collaboration with our discovery and clinical stakeholders to drive innovation in the field of oncology drug development.

Qualifications and Requirements:

+ Ph.D. in a relevant scientific discipline with 8 plus years of experience in the pharmaceutical/biotechnology industry, with a focus on biomarker science for oncology and immunotherapy. 10+ years' experience is preferred.

+ Strong knowledge of biomarker discovery and development in clinical trials, including assay development, validation, and data analysis.

+ Demonstrated experience in leading clinical biomarker development for innovative early or late clinical development as evidenced by a strong publication record and/or regulatory approvals.

+ Well regarded in the scientific community as an expert in a specific disease or with an important technology platform as evidenced by invited talks, panel participation, etc.

+ Demonstrated experience in leading cross-functional teams in the development and execution of biomarker strategies for clinical trials.

+ Strong communication and presentation skills with the ability to generate scientific reports and presentations.

+ Demonstrated ability to work in a fast-paced, dynamic environment.

+ Demonstrated ability to lead and mentor junior scientists.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.