Our client is an innovative, stealth mode biotech company working to treat common diseases that afflict large numbers of patients through genetic medicines. They are building therapeutics that will modify and control multiple genes at the DNA, RNA, and/or protein level in vivo and are seeking an Associate Director/Director of Preclinical, reporting to the Head of Preclinical.
About the Role:
As an Associate Director/Director reporting to the Head of Preclinical, you will lead the design and execution of scientifically rigorous in vitro and in vivo studies, selecting appropriate disease-specific cellular and animal models to move the preclinical programs towards IND-enablement. This position will lead from the bench and work in close collaboration with our therapeutic program and platform technology teams, you will:
• Develop and execute against the criteria outlined in the Target Candidate Profile for each therapeutic candidate in the pipeline.
• Develop plans to execute against the strategy for in vitro and in vivo disease modeling research, including vendor selection and management and resource allocation.
• Coordinate assay development and execution of bioanalytical assays and other study read-outs, working with both internal and external resources.
• Manage, oversee, train, and mentor scientists and research associates and foster a collaborative environment within the team and with external partners
• Ensure the quality of in vivo studies conducted by external vendors, including compliance with all regulatory and ethical standards.
• Support IND-enabling studies including toxicology, CMC, immunology, and related.
• Maintain comprehensive, accurate records to support scientific best practices, diligence, IND submissions, etc.
• In all cases, you will ensure that study design and execution aligns with the company's research goals, timelines, and budgets.
Requirements:
• A Ph.D. in neuroscience, pharmacology, physiology, drug delivery, genetics or a related life sciences discipline, with at least eight years of drug development experience leading preclinical assay development efforts.
• Experience working in preclinical gene editing and/or gene therapy programs.
• Extensive experience in leading and designing in vivo studies, with a proven track record in managing external vendor relationships, including contract negotiation and oversight.
• In-depth knowledge of cellular and animal models used in drug development research and experience in applying these models to in vivo studies.
• Strong leadership abilities, with experience in managing scientific teams and fostering collaborative internal and external research environments.
• Demonstrated ability to work closely with senior leadership to ensure research efforts align with organizational strategy.
• Ability to think creatively and drive for success in a fast paced and agile work environment.
Preferred Qualifications:
• Drug development experience in neurobiology programs.
• Experience working in dynamic startup and/or small company environments that necessitate pitching in and assisting with a wide variety of important tasks.
• A desire to create effective policies and procedures from the ground up.