Associate Director Biomarker Expert - US
Company: Principia Biopharma Inc.
Posted on: June 12, 2021
Provide scientific and strategic input to develop biomarker
plans that contribute to successful progress in drug development
programs. The incumbent is expected to demonstrate proficiency in
review of diverse and complex subject matter to identify and
propose need specific biomarkers that will significantly contribute
to milestone decisions during drug development and eventual
successful approval of said drugs/therapeutics. The incumbent will
act as a resource for current and emerging biomarker technologies.
Participation in Translational Medicine Early Development (TMED)
Working Groups and project teams is expected. Incumbent is expected
to serve as an expert advisor to project teams to formulate,
present and advocate for rational, data driven biomarker
activities. Key skills include in depth experience and successful
track record in biomarker assay development, technology platforms,
troubleshooting and validation, and elements of data quality.
Additional responsibilities include overseeing routine and complex
biomarker experiments conducted in internal or external
laboratories which includes return of data and reports to project
teams. The incumbent will promote the conduct of experiments with
high quality and within expected timelines.
Essential Job Duties and Responsibilities:
Must have a thorough understanding of standard and emerging
biomarker assay technologies for development and validation of
complex assays, including capability to identify potential issues
and trouble-shoot assays when problems are identified.
Serve as a Lead (representing the Biomarkers and Clinical
Bioanalysis (BCB) group) to support project teams to select
relevant biomarkers utilizing the best assay technologies to
support project objectives, with subsequent implementation of those
Provide scientific input and oversight on biomarker sample
collection, shipment and storage, sample analysis, and return of
Contribute to achievement of team biomarker objectives with high
quality and within timelines. Develop productive relationships with
personnel in internal and external groups involved in biomarker
Contribute to high quality, timeliness, and following of
regulatory requirements with internal laboratories and external
Participate in meetings and other activities of project teams,
translational medicine subteam, working groups, and other relevant
groups as needed to contribute to projects.
- In support of projects and innovation, assist BCB, TMED and
other groups regarding biomarker-specific scientific, operational
and regulatory issues and opportunities.
Required Educational Background and Job-Related Experience:
Ph.D. in biochemistry, immunology, pharmacology, genetics,
bio-analytics, or related scientific discipline with 5 or more
years of industry experience, or a Masters Degree with 7 or more
years of experience.
Experience with biomarker assay development and validation,
especially for large molecules or nucleic acids.
- A diverse skill set in bio-analytical assay development
methodologies such as ligand binding (ELISA, MSD, etc.),
multiplexed biomarker analysis, and enzymatic activity assays.
Knowledge and Skills Required:
Strong interpersonal and organizational skills.
Familiar with regulatory expectations (FDA, EMA, Asia-Pacific)
and industry best practices in analytical assay development and
validation of bio-marker assays.
- Strong desire to continue to develop scientific expertise in
biomarker technologies and utilization in drug development.
Knowledge and Skills Desirable but not Essential:
Emphasis on team driven approaches to problem solving and
ability to build and nurture a collaborative network among peers
and colleagues considered a plus.
Prior experience serving on drug development project teams.
Experience with bioinformatics, quality, regulatory,
outsourcing, or drug development.
Experience in data analysis and interpretation.
Experience with small molecule drug metabolism and
- Experience with pharmacogenomics.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and
Affirmative Action employers committed to a culturally diverse
workforce. All qualified applicants will receive consideration for
employment without regard to race; color; creed; religion; national
origin; age; ancestry; nationality; marital, domestic partnership
or civil union status; sex, gender, gender identity or expression;
affectional or sexual orientation; disability; veteran or military
status or liability for military status; domestic violence victim
status; atypical cellular or blood trait; genetic information
(including the refusal to submit to genetic testing) or any other
characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we
operate and embedded in our Core Values. We recognize to truly tap
into the richness diversity brings we must lead with inclusion and
have a workplace where those differences can thrive and be
leveraged to empower the lives of our colleagues, patients and
customers. We respect and celebrate the diversity of our people,
their backgrounds and experiences and provide equal opportunity for
Keywords: Principia Biopharma Inc., Cambridge , Associate Director Biomarker Expert - US, Other , Cambridge, Massachusetts
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