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Associate Director, Bioanalytical and Bioinformatics
3 months ago
Position Overview:
Astria Therapeutics is dedicated to bringing hope with life-changing therapies to patients and families affected by allergic and immunological diseases. Astria’s pipeline includes our lead program, STAR-0215, a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the treatment of hereditary angioedema, as well as STAR-0310, an OX40 monoclonal antibody antagonist currently in pre-clinical development for atopic dermatitis (AD) and being explored for other allergic and immunological diseases.
The Associate Director, Bioanalytical and Bioinformatics will provide scientific and technical leadership across Astria’s portfolio and be responsible for management and oversight of bioanalytical vendor relationships, supporting assay development and validation for our nonclinical and clinical programs.
Responsibilities:
- Strong background and successful track record in bioanalytical assay development, optimization, and troubleshooting with experience in: transcriptomics, pharmacogenomic analyses and interpretation, biomarkers (including pharmacodynamic biomarkers), flow cytometry, PK, ADA, and nAb methods
- Familiarity with bioanalytical GxP and regulatory guidelines
- Experience in developing and implementing a biomarker testing strategy
- Ability to analyze and interpret data, guide vendor efforts to best meet the needs and timelines of studies/programs
- Experience/previous position in a GxP compliant bioanalytical environment
- Possesses excellent verbal and written communication skills and is detail oriented
- Familiarity with a variety of assay platforms and a strong bioanalytical mindset
- Strong planning, organization, and project management skills
- Managed timelines and deliverables (data and bioanalysis reports) for specific programs.
- Effective communication skills
- Collaborative, and scientifically curious nature
Qualifications:
- MS or Ph.D. in Chemistry, Biology, Biomedical sciences or related discipline.
- Technical leadership: Ability to oversee and manage bioanalytical vendor relationships to establish, optimize, qualify/validated phase-appropriate assays supporting nonclinical and clinical programs
- Guide method development, validation, and sample testing of bioanalytical methods to ensure generation of quality scientific data and meet program timelines
- Strong organization skills and ability to partner with program leadership to streamline and advance research deliverables.
- Work cross-functionally with Astria’s internal teams and our external partners to progress bioanalytical deliverables and timelines for multiple pipeline priorities.
- Collaborate with bioanalytical vendor to troubleshoot method when needed.
- Review/interpretation of data to ensure suitability for regulatory submissions
- Review, provide sponsor feedback, and approve study plans, reports, and other documents
- Collaborate with clinical or nonclinical operations to develop appropriate laboratory manuals and assist with coordination of all bioanalysis activities.
- Support early research assay development activities
- Maintain awareness of novel approaches and new technologies
- Stay current in literature, regulatory guidelines, white papers, to ensure phase appropriate, fit-for-use, and best practices in method development and validation
- Other responsibilities as assigned
Astria’s Commitment:
At Astria, we are committed to building a diverse team where every Astrian endorses the idea that people bring their authentic self to work. We embrace a patient-first, people-always culture which strives to ensure all Astrians and our collaborators have a sense of belonging and receive the support they need to thrive. We invest in our people through our words, our actions, and our values. We are working to develop and implement initiatives that promote diversity, equity, and inclusion throughout the organization and foster a culture of openness, respect, and collaboration, where all voices are heard, and everyone is valued for their unique perspectives and contributions.
People are our greatest asset, and only with a diverse team can Astria shine brighter. Together we can bring our passion and compassion to the work of delivering life-changing therapies to patients, families, and communities.
