Director Translational Biomarker Development – Rare Disease
Location: Bedford, MA
Director Translational Biomarker Development will be an important member of the R&D team, leader of the bioanalytical function, representative on program core teams, providing strategic inputs for assay development efforts to ensure rapid and high-quality execution of biochemical and molecular assay development/qualification and sample analysis to support PK/TK, metabolism, drug distribution, drug mechanism of action, PD and biomarkers, and immunogenicity assessments to advance HMI’s therapeutic platform.
Essential Functions and Duties
- Provide expertise and leadership on development and implementation of program specific assays within program timelines.
- Build a high-quality bioanalytical function, organize expertise within the team, to support development, testing, analysis and review of results for early preclinical, pivotal IND-enabling studies, and clinical studies.
- Prioritize and coordinate assay development efforts across programs; build systems and resources for rapid sample analysis from different studies
- Provide testing results from methods such as q/ddPCR for tissue vector copy number, bulk transcription profiling with RT-qPCR, Immunoassays (ELISA, MSD) for biomarker detection, Cell-based assays including neutralizing antibody and EIispot assays to support studies preclinically and clinically for development of AAV products
- Keep current with advances in bioanalytical methodologies; evaluate, assess risks, and recommend new technologies that will be useful in expanding and enhancing gene therapy applications in model systems.
- Identify and collaborate with external CRO to support assay development, validation and testing of samples to meet timelines for nonclinical and clinical studies, provide clinical teams with validated assays for sample analysis.
- Review and finalize assay reports to ensure scientific validity and regulatory requirements, and author IND /MMA/BLA sections related to bioanalytical methods and sample analysis, sections; participate in scientific advice preparations and meetings
- Oversee sample testing, monitor data quality and work closely with the clinical pharmacology group to support data analysis and interpretation.
- Commit to help the team provide deliverables and meet aggressive timelines
Skills and Experience
- PhD in biological sciences such as immunology, cell and molecular biology
- Thorough knowledge and direct experience in assay development, qualification and validation, with scientific depth to support interpretation of results
- Experience developing assays intended use included drug PK/TK, PD (mRNA and protein), additional safety and efficacy biomarkers, immunogenicity (including but not limited to anti-drug antibodies).
- Demonstrated history of working innovatively and efficiently while managing multiple projects, scientists and research associates
- Demonstrated success and desire to work with a diverse team in a fast-paced environment under challenging timelines
Interested candidates should forward a cover letter and Resume / CV to email@example.com or on line: www.homologymedicines.com
Homology Medicines, Inc. (HMI) has built foundational intellectual property on gene editing and gene therapy vectors derived from naturally occurring human adeno-associated viruses (AAVs). The Company's technology is precise, on-target and highly efficient for in vivo editing of genetic mutations. This transformative platform technology, combined with an elite leadership team of biopharmaceutical industry veterans, create a significant opportunity for HMI to rapidly advance a diverse pipeline of new medicines that address and potentially cure the underlying cause of genetic diseases.
Location/Region: Bedford, MA