Bristol-Myers Squibb Company

Associate Director Clinical Genetics and Genomics

Location
Hopewell, NJ, United States
Posted
Aug 09, 2019
Ref
R1514892
Required Education
Bachelors Degree
Position Type
Full time
Summary

The BMS Clinical Genetics and Genomics Group is seeking a highly experienced subject matter expert for the role of Associate Director. The individual will play a key role in the evolution and development of the team in addition to leading the development, validation, implementation, and growth of genomics fluency and application to support the company's pipeline across all active therapeutic areas. The group is responsible for the application of relevant technologies to measure specific genetic or genomic endpoints in clinical studies which support 1) mechanism of action hypotheses, 2) pharmacokinetic/ pharmacodynamic evaluations, and 3) patient stratification or 4) novel biomarkers related to clinical response. He/ She will liaise closely with various stakeholders to ensure implementation of the appropriate genetic and genomic assays in early clinical studies and development of assays with regulatory rigor. The individual will serve as a genomics subject matter expert for clinical programs as also for stakeholders in diverse teams within BMS associated with clinical development and diagnostic development. The position will involve leading and mentoring a team of scientists and stakeholders in a direct or matrix mentoring role.

Job duties

Drives development of genomics clinical trial assays with focus on developing assays for appropriate regulatory rigor and global implementation.

Works closely with the Pharmacodiagnostic and regulatory teams on development of clinical trial assays for PDx application.

Drives the implementation and growth of NGS technology, supports ongoing development, validation and troubleshooting of NGS assays, including targeted DNA-seq and RNA-seq, WES, and WGS.

Oversees operations of different NGS workflows; from sample preparation, library construction, data generation, data processing to interpretation of results, ensuring a high level of quality and reliability of generated results.

Implements data processing and analysis workflows in alignment withcolleagues in bioinformaticsbioinformatics pipelines, and data storage procedures in collaboration with internal and external multidisciplinary teams.

Effectively manages available resources, distributes assignments and delegates workload as needed to achieve timely execution of projects, works with cross functional teams (internal and external teams) to execute plans and set deliverables.

Serves as a subject matter expert for NGS technology, provides guidance on experimental design, method or platform selection, and data management to address a specific need.

Educates laboratory staff and/or contractors, conducts hands-on training, and delivers internal and external presentations.

Learns various NGS platforms, stays on the top of the scientific and technical innovations, and follows new trends and developments in genomic technologies to uphold BMS's competitive advantage.

Drafts experimental plans, validation reports, work instructions, technology transfer documents, study summaries and SOPs.

Actively participates in internal/external collaborations, portfolio management groups and clinical study and biomarker execution teams.

Minimum requirements

The candidate must havePostdoctoral experience with work experience in clinical genomics and genomics biomarker teamsin a relevant scientific field, such as molecular biology, genetics and genomics, biochemistry, or other related disciplines, ideally in a pharmaceutical, biotech or clinical diagnostics industry.

Must have minimally 4-5 years of demonstrated expertise in application of genomics technology to clinical trial assay implementation (development, validation, troubleshooting).

Must have demonstrated expertise in fields of NGS based diagnostic development.

Must have an in-depth knowledge of different NGS platforms and technologies and understanding of parameters for commercial application to Dx directed implementation of genomics strategies.

Must have a strong understanding of regulations and guidelines for genomics test development and regulatory standards globally (including but not limited to FDA, CLSI, NYDOH, CAP, CLIA, EU directive and ex-US Dx and clinical assay implementation guidances).

Technical expertise with molecular diagnostic testssuch asqPCR, PCR, digital PCR, Nanostring, fluid biopsy developmentand other relevant genomics diagnostic platforms are highly desired.

Must have strong organizational and interpersonal skills, must display excellent leadership and people skills, and demonstrate ability to work collaboratively with others in a highly matrixed environment.

Mentoring and team building abilities will be highly valued.

Must be familiar with different NGS software platforms, bioinformatics pipelines and NGS data processing and interpretation solutions.

Ability to analyze and QC data in conjunction with a dedicated bioinformatics team will be desirable.

Must be self-motivated, with a demonstrated ability to work independently and learn quickly.

Must be goal oriented and focused on completing work on time.

Must be able to quickly adapt to changing priorities and work well in fast pace environment and under pressure.

Must possess good communication and presentation skills.