Exploratory Biomarker Assay Group Leader
- BS/MS in biochemistry, biology, immunology or related discipline with greater than 10 years of experience developing and validating novel biomarker assays (LC/MS, immunoassay, flow cytometry, qPCR, immunohistochemistry, mass cytometry, etc.) with a strong laboratory hands-on experience and in-depth theoretical understanding of ligand-binding biomarker assay development, validation and implementation.
- Candidate must have in-depth understanding and hands-on expertise of biomarker.
- Proven ability to provide biomarker/translational expertise on programs/project teams for pre-clinical and clinical studies with a wide variety of techniques and technologies.
- Maintains a disciplined approach, ensuring a relentless focus on quality, compliance, scientific rigor and operational excellence
- Highly motivated team player with a proactive attitude, excellent organizational skills and a demonstrated ability to interact effectively within a multi-disciplinary team are essential.
Phd inbiochemistry, biology, immunology or related discipline
GlaxoSmithKline (GSK) is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to create a platform for the delivery for strong growth in a rapidly changing healthcare market. Our mission is to improve the quality of human life by enabling people to do more, feel better and live longer.
We are looking for a highly motivated, agile and experienced scientist & manager to lead a team in the Exploratory Biomarker Assay group within the Bioanalysis, Immunogenicity and Biomarkers (BIB) department based in Stevenage, UK. This group is responsible for developing and validating biomarker assays for use in pre-clinical PK/PD/modeling studies and translation into the clinic in alignment with therapy area partners. Data from this group is a key component to understanding molecules in the GSK pipeline; and serves to enable studies to prove target engagement for novel mechanism of action and safety endpoints.
This individual will provide leadership for the strategy, management of staff, as well as delivery of biomarker assays and data for PTS and R&D. This group measures biomarkers (both exploratory and to GxP guidelines) in relevant biophases (systemic or tissue) to drive pre-clinical and clinical PK/PD, efficacy or safety outcomes.
- Holds themselves and their group accountable for delivery high quality bioanalytical biomarker results, and be fully compliant with regulatory requirements. Reviews and monitors the quality level of group's output.
- Actively contributes to the development and implementation of WW departmental analytical strategy (scientific, quality, regulatory, and contracting). Communicates and embeds the strategy and vision to group members.
- Ability to translate a project team's biomarker needs into a valid biomarker assay and act as a analytical scientific expert in discussions on science/project progression within GSK.
- Works effectively as a matrix leader to ensure minimal impact between studies supported internally and externally. Works closely with other BIB group leaders to effectively balance bioanalytical resource delivering timely high quality data to projects.
- Provide senior scientific leadership and set strategic direction of technology advancement. Drive an assay technology agnostic attitude and openness to new technologies supporting any modality. Proactively identify and provide cross-training opportunities for their staff within BIB.
- Build effective relationships with the analytically supported groups within and outside of PTS to balance stakeholder expectations with scientific quality and validation requirements ensuring limitations of assays and data are well understood.
- Has the necessary experience and knowledge to represent the department in regulatory interactions (questions, and filings) and at high level relevant regulatory meetings (eg FDA, EMA, MHRA).
- Well connected with the leading industry and academic thought leaders.
If requiring an adjustment for a disability, once selected for
Interview you may contact [email protected]
During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process.
If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.
Closing date for applications: 28th September 2017
When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above.
The information that you have provided in your cover letter and CV will be used to assess your application.
Thank you for your interest in this opportunity.
You may apply for this position online by selecting the Apply now button.
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