Head of Pre-Clinical
CODA Biotherapeutics (www.codabiotherapeutics.com) is an early-stage venture backed biotechnology company located in South San Francisco, California. Our chemogenetics platform aims to treat neurological indications through modulation of specific target cell activity utilizing engineered ligand gated ion-channels delivered via gene therapy. The engineered ligand-gated ion channels are designed to interact with defined small molecule therapeutics and act as a switch to activate or inactivate specific neuronal populations as a means for treating neurological diseases.
We are looking for a highly motivated and dynamic candidate for the Head of Pre-Clinical (Associate Director / Director level), reporting to the Head of Gene Therapy. The ideal candidate will have a strong background in neurological disorders, with knowledge of neuropathic pain and epilepsy. This position will be responsible for leading pre-clinical and early-stage gene therapy development activities for CODA’s pipeline, specifically develop strategic plans for preclinical proof-of concept efficacy studies and non-clinical development. The ideal candidate will work closely with the R&D team and be responsible for planning, developing, and leading efforts to set up disease models, perform in vivo efficacy studies and generate POC for the two lead programs at CODA, including neuropathic pain and focal epilepsy. Additional nonclinical activities would include participating in design and management of pharmacology and toxicology studies for clinical candidate development at CROs. This individual will be highly collaborative, and will established processes, policies, and quality systems for outsourcing, managing and reporting studies, and other activities in support of CODA’s gene therapy pipeline.
- Identify and establish disease models for CODA’s lead programs – neuropathic pain and focal epilepsy. As well as other neurological indications that are identified.
- Design and manage proof-of-concept preclinical studies either in-house or with outside partners/ CROs.
- Design and manage preclinical studies (GLP and non-GLP) for inclusion in regulatory submissions including pharmacology and toxicology.
- Oversee nonclinical studies conducted by CROs and other third parties.
- Work closely with cross functional team members to ensure all in vivo proof-of-concept as well as toxicology and pharmacology studies are completed in a quality, timely, and scientific manner.
- Lead, manage, and train a team of scientists and research associates to develop and run in vivo studies, perform thorough analyses, and provide high quality reproducible data to move early stage programs into development.
- Provide guidance to project team members through evaluating the impact of study results on program and clinical/regulatory strategy.
- Lead the generating of nonclinical documents for health authority submissions to both FDA and EMA (ie INDs, IMPDs, brochures, briefing documents, nonclinical study reports and nonclinical summaries to support regulatory submissions). This is not required but a “nice to have”.
- Partake in identification of additional programs that would fit with CODA’s vision and could be added to its pipeline.
Education & skills
Thinks critically and creatively and is able to work independently, determine appropriate resources for resolution of problems and have strong organizational and planning skills
- Minimum PhD in Biological Sciences or related field
- 5+ years of nonclinical development experience in pharmaceutical or biotech company, or in a core at an academic institution
- Background in viral vector gene therapies, preferably AAV
- Hands-on experience in performing and leading preclinical in vivo studies and developing disease models for neurological conditions
- Expertise in neurological disorders. Deep knowledge of neuropathic pain and epilepsy, preferred
- Previous project leadership and team management as well as management of CROs and scientific collaborators is needed
- Knowledge of US FDA and European nonclinical regulatory requirements for combination gene therapy with hands-on experience supporting submissions of such regulatory documents, would be a bonus
- Ability to operate in a fast-paced, collaborative environment along with strengths in delivering results on-time in support of discovery/development programs
- Demonstrate strong verbal, written, presentation, and interpersonal communications skills with the ability to explain complex concepts with clarity and simplicity.
CODA Biotherapeutics, Inc. is an Equal Opportunity Employer, and offers a comprehensive benefits package including health, dental, vision, generous paid time off and much more.