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Associate Director Biomarker Expert - US

Company: Principia Biopharma Inc.
Location: Cambridge
Posted on: June 12, 2021

Job Description:

Position Overview:

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 technologies.

  • Provide scientific input and oversight on biomarker sample collection, shipment and storage, sample analysis, and return of data.

  • 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 activities.

  • Contribute to high quality, timeliness, and following of regulatory requirements with internal laboratories and external service providers.

  • 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 pharmacokinetics.

  • 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.

#GD-SG

#LI-GZ

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 all.

Keywords: Principia Biopharma Inc., Cambridge , Associate Director Biomarker Expert - US, Other , Cambridge, Massachusetts

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