Research Scientist II, Biomarker Sciences- Seattle
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POST DATE 9/7/2016
END DATE 12/8/2016
Gilead Sciences, Inc
JOB DESCRIPTIONSPECIFIC RESPONSIBILITIES
We are seeking an experienced biomarker scientist to support our therapeutic areas of interest including inflammation, oncology, and virology. The Research Scientist II will be responsible for the development and implementation of biomarker strategies to enable the discovery, development, and commercialization of medically-differentiated therapies. This person will lead the biomarker strategies for individual clinical projects through interfacing with Research Biology and Clinical Research, as well as by developing collaborative external relationships with key opinion leaders. He/she will interface with both discovery and development project teams, providing expertise on state of the art thinking on biomarker and diagnostic technologies, including their scientific basis, clinical applicability, validation status, and statistical issues related to their implementation. Gilead is a highly matrixed organization and the ability to work effectively across functional groups is a key attribute for this role. Typical activities of this role include:
* Develop, communicate, and execute strategic plans for collecting actionable biomarker assessments in clinical trials, including pharmacodynamic, prognostic, predictive, and safety markers.
* Author relevant sections of clinical protocols and other study documents, and participate in meetings with regulatory authorities when needed.
* Implement the biomarker plan by directing assay development, CRO selection and assay transfer, external validation, and assessment of clinical study samples.
* Oversee data analysis, interpretation, and communication in collaboration with biometrics.
ESSENTIAL DUTIES AND JOB FUNCTIONS
Facilitate the development and execution of specific elements of the biomarker and diagnostic strategy for individual research and development projects
Provide expertise to research and development teams to ensure their understanding of appropriate biomarker and diagnostic technologies, evaluating their scientific basis and clinical applicability, the validation status and any technical or statistical issues related to the proposed biomarkers and/or diagnostic assays
Be a point of contact to provide expert scientific advice to other functions (e.g. Contracts, Clinical Operations, Data Management, etc.) in their interactions with internal and external service laboratories related to biomarker sample collection, storage and analysis.
Design, implement and oversee biomarker and diagnostic testing and data analysis:
- Direct the development, outsourcing and validation of clinically applicable BM assays
- Design, implement and monitor BM and Dx testing and data collection
- Collaborate with biostatistics and bioinformatics colleagues to design data analysis plans
Expertise and consistent success in scientific research and/or clinical practice (as evidenced by appropriate qualifications, publications and relevant specialist accreditation)
Ability to lead specific tasks within a project including motivation and delegation
Experience with assay characterization, validation and outsourcing
Awareness of the challenges of implementing biomarker and diagnostic technologies in the clinical setting
Good initiative and ability to work independently with minimal supervision
Some business awareness
Good verbal and written communication and presentation skills in English
KNOWLEDGE, EXPERIENCE AND SKILLS
3+ years of experience with PhD or MD/PhD in related scientific discipline.
BS or MS degree with extensive industry experience.
* Proven success in human translational research in industrial or academic settings, with direct experience validating and implementing biomarker assays in clinical trials.
* Excellent written and verbal communication and presentation skills.
* Ability to excel in a fast-paced and matrixed environment.
* Strong motivation, attention to detail, and ability to think independently and fully integrate into a high achieving team environment is essential.
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact firstname.lastname@example.org for assistance.
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