Drug Dev and Preclinical Studies
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
The Clinical Genetics and Genomics team is seeking an innovative and highly motivated scientist to join our world-class team. The selected scientist will be responsible for developing program biology based biomarker strategy for genomics assets and assume responsibility for genomics biomarker assay development, optimization, validation and execution of biomarker analysis for BMS translational research and clinical programs. The scientist must have a strong background in genomics and its application in clinical programs as well as experience with and understanding of immunology or immunoscience related disciplines.
- Help develop genomics strategy for programs per underlying program biology, mechanism of action criteria. Work closely with program and biomarker leads in a matrix team.
- Assay design and development: Help develop the framework for assay development, validation and timely, well planned execution of assay and clinical analysis working with cross-functional teams.
- As an individual contributor and leading in a matrix organization design, develop, optimize genomics and genetics biomarker assays and develop and execute the validation of these assays for clinical trial assays.
- Key assay profiles likely to include NGS or qPCR based gene expression systems, genotyping or variant analysis utilizing NGS or qPCR or other methodologies.
- A significant part of time will be spent assisting development and analysis of validation data. A strong understanding of assay validation and fit for purpose assay validation requirements will be essential.
- In case of outsourced studies, the incumbent will provide subject matter expertise and oversight of assay development and execution of sample analysis at the vendor.
- Drafts experimental plans, validation reports, work instructions, technology transfer documents, study summaries and SOPs.
- Actively participate in internal/external collaboration, portfolio management groups and clinical study and biomarker execution teams.
- Providing subject matter expertise for clinical and program teams as required.
- Accurate record keeping of experiments and procedures
- Act as a technology evangelist and help assess and onboard relevant technologies working with matrixed teams per program requirements.
- Work closely with data analysis teams as well as sample management and clinical operation teams on programs.
- Provide mentorship and leadership in the program team and smaller technology matrix teams.
- Work to develop a lean organization with highly efficient genomics processes and best practices.
- Educational qualifications would be Postdoctoral and work experience with Genomics application for translational research
- 2-3 years Postdoctoral or work experience in Pharma R&D or clinical or diagnostic Genomics lab
- Ssubject matter expertise in genomics application to studies of immunology, immunooncology is required.
- Recognized work experience in immunogenomics is required with demonstrated ability to develop biomarker strategic plans, assay development and validation proposals.
- The candidate must demonstrate significant work experience in clinical assay development for genomics assets preferably in a pharma, biotech or clinical lab setting.
- Understanding of fit for purpose genomics assay validation principles for clinical assays.
- Good understanding of genomics assay validation guidelines and guidances (FDA, CAP, CLIA, ACMG).
- Expertise in genomics (NGS, qPCR, variant analysis platforms) assay development, validation, troubleshooting, and reviewing of run QC data.
- In-depth knowledge of different genomics platforms and technologies (for the clinic).
- Familiarity with NGS and qPCR data analysis and QC to develop a strong interaction with the data analysis team.
- Technical expertise with molecular technologies, including but not limited to: NGS, single cell NGS, biofluid analysis, quantitative real-time PCR, digital PCR, NanoString, as well as cutting edge genomics technologies..
- Must have strong organizational and interpersonal skills.
- Must display excellent leadership and mentoring qualities for technical team and matrixed team.
- Thrive in a highly interactive, fast-paced and dynamic team environment.
- Agile and efficient work philosophy-stress on execution of excellent quality science.
- Leadership and mentoring abilities with potential to lead and oversee technical team in a matrixed organization.
- Ability to work in a matrixed team in a high pressure environment.
- Excellent communication skills with ability to serve as key contact for program teams.
- Must have excellent organization and record keeping skills
- Must be highly resourceful and work across matrix teams.
- Previous experience in a clinical laboratory setting is a plus.
- Bioinformatics skills, experience with data interpretation and basic data analysis are preferred.
- Understanding of design of experiments, randomization of samples for clinical analysis is preferred.