Senior Principal Scientist, Group Lead, Genomics, Translational Molecular Biomarkers

Job Description

Translational Molecular Biomarkers (TMB) is responsible for the development and execution of clinical biomarker assays across all therapeutic areas and all phases of clinical development at our company's Research laboratories. TMB laboratories leverage a diverse array of technologies to develop biomarker assays to help confirm engagement of therapeutic targets and understand mechanisms drug action and patient response.

The TMB organization is seeking a highly-motivated candidate to head our Genomics team. The individual will lead a group of colleagues whose role is to develop and validate Genomics assays that are deployed in support of clinical trials. The candidate for this Senior Principal Scientist and group lead position should have extensive technical expertise in genomics and molecular biology and should have a strong desire to lead a lab-based genomic assay group. In addition, the successful candidate should have demonstrated the ability to collaborate closely with out-sourcing partners on the scientific oversight of genomics assays that support clinical trials.

The successful candidate will have the following responsibilities:

• Oversight of the development and validation of genomics assays within TMB for all therapeutic areas and all phases of clinical development.

• Assist in the transition of biomarker assays from Basic Research to Clinical implementation by providing technical guidance on fit-for-purpose assay validation.

• Interface with scientists and physicians in early and late-stage clinical development to execute on biomarker strategies in clinical trials.

• Reviewing/writing memos, final reports, related regulatory documentation and publications summarizing data, and reviewing/editing lab SOPs.

• Serve as a subject matter expert in genomics-based assay development and validation, collaborating with project teams, biomarker leaders, companion diagnostics leaders, clinical operations and regulatory affairs on the implementation of these assays in clinical trials.

• Coaching and mentoring a team of dedicated scientists to ensure their career goals are aligned with the goals of the company

• Providing strategy and vision to evaluate and deploy new technologies/platforms in the Genomics group

Position Qualifications:

Education Minimum Requirement:  

• Ph.D or Ph.D/MD in a life sciences discipline (Biochemistry, Immunology, Genetics, Molecular Pathology, Cell Biology, etc.) or Chemistry

Required Experience and Skills:

• A minimum of 10 years of clinical laboratory or pharmaceutical industry experience in a related discipline (e.g. molecular biology, biochemistry, etc.).

• A minimum of 7 years of direct experience in genomics-based assay development for clinical implementation

• Extensive experience with Next Generation Sequencing and qPCR platforms and analysis

• Strong interpersonal, verbal and written communication skills

• Ability to execute within a matrixed organization and collaborate with cross-functional teams

• Extensive knowledge and experience with regulatory requirements for patient sample testing and with lab licensing and accreditation (e.g. CLIA/CAP), including considerations for assays used for patient enrollment in clinical trials

• Experience supporting technical oversight of assay development, including companion diagnostics

• Broad knowledge of the drug development process and translational medicine

Preferred Experience and Skills:

• Experience with data analysis and interpretation using advanced bioinformatics tools

• Formal training in Laboratory Medicine; experience with performing clinical testing services for diagnostic and therapeutic evaluations.

• Demonstrated strong record of scientific achievement through publications, patents, peer awards and other recognition

• Expertise in molecular diagnostics and human molecular genetics

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