Associate/Director - Translational Medicine Expert, Discovery
Novartis
Associate Director – Bioanalytical Sciences, Translational Medicine, Nonclinical Development
BlueRock Therapeutics
full-time
Posted on:
Location Type: Hybrid
Location: Cambridge • Massachusetts • 🇺🇸 United States
Visit company websiteJob Level
Senior
About the role
- The Associate Director of Bioanalysis, Translational Medicine and Nonclinical Development, will be expected to take on a highly visible role with internal and external stakeholders through the management of clinical and preclinical biomarker analysis for BlueRock’s development programs.
- The Associate Director will leverage their bioanalytical biomarker expertise to advance the company’s pipeline. As part of the Translational Medicine and Nonclinical Development team, this role provides unique opportunity to impact the development of novel cell therapies in multiple therapeutic areas including neurology and ophthalmology.
Requirements
- PhD required with 5+ years of industry and/or CRO experience required.
- Develop, and validate biomarker assays to support biomarker measurement in clinical samples, ensuring that methods meet health authority expectations and fit-for-purpose requirements.
- Manage and monitor bioanalytical activities at contract research organizations. Drive process improvements for assay lifecycle management, sample logistics, and data workflows.
- Partner with bioinformatics/data science teams to ensure high-quality data capture, curation, and transfer for downstream analysis.
- Provide bioanalytical biomarker expertise and oversight to program teams at all stages of drug development from research to clinical. Evaluate and implement emerging bioanalytical technologies to expand biomarker capabilities.
- Collaborate with Clinical and Biomarker Leads to ensure biomarker assays align with study endpoints and scientific objectives.
- Review and approve study plans, assay validation reports, and bioanalytical study reports. Contribute to biomarker sections of regulatory submissions
Benefits
- Equal Opportunity Workplace: At BlueRock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
bioanalytical biomarker expertisebiomarker assay developmentbiomarker assay validationdata workflowssample logisticsprocess improvementsbioinformaticsdata curationemerging bioanalytical technologiesdrug development
Soft skills
stakeholder managementcollaborationoversightcommunication
Certifications
PhD