Manager – Translational Biology

Manager – Translational Biology

Requirements

• An advanced degree in a scientific discipline is required with 3-5 years of experience in the biotech/pharmaceutical industry within a laboratory setting. PhD is strongly preferred.
• Knowledge of neuromuscular biology, gene and siRNA therapies especially in the context of rare genetic disease.
• Strong writing skills to support method validation reports, regulatory modules associated with NDA and BLA submissions.
• Demonstrated hands-on experience with implementation of biomarker analysis in clinical laboratory studies under regulatory guidelines.
• Laboratory experience in bioanalytical assay including PK and PD development, transfer, validation under GCP/GLP compliant conditions.
• Understanding of late-stage drug development, clinical operations and experimental design within clinical research environment.
• Proven scientific leadership when working with collaborative, multi-functional teams.
• Excellent technical writing and communication skills; able to articulate complex scientific concepts to diverse functional groups and external stakeholders.

Responsibilities

• Oversee development and validation of clinical assays and conducting sample analysis, under the direction of project management teams, using a variety of assay formats such as Pharmacokinetics, PCR, Western blot, IHC and NGS while ensuring compliance with associated protocols, methods, and procedures.
• Writing bioanalytical reports and contributing to the regulatory modules for clinical assays.
• Work closely with Quality Control and Quality Assurance to ensure compliance with GDP, GCP, GLP, and appropriate regulatory guidelines, including writing and reviewing SOPs, technical reports, and publications, and maintaining compliant laboratory records.
• Contribute to laboratory compliance, inspection readiness activities and regulatory agency related written communications as an SME for this function. Laboratory compliance includes but is not limited to being up to date with the required trainings and following the laboratory cleaning and maintenance SOP.
• Take a lead role in the development and validation of fit-for-purpose bioanalytical methods for various clinical stage programs.
• Coordinate activities and timelines through close collaboration with project management teams, research teams, as well as cross-functional Translational Biology colleagues. This includes maintaining sample testing trackers, summary statistics for reports, and testing metrics.
• Organize and track complex information, prioritize accordingly, and quickly adjust to shifting priorities and demanding timelines to support the overall goals of the department.
• Work extended hours as needed, including but not limited to weekend and holiday coverage, occasionally on short notice.
• Additional responsibilities as assigned.

Preferred Qualifications

• PhD is strongly preferred.