Scientific Director- In Vivo Study Operations and CGT

Location: San Diego/Carlsbad, California 

If you are looking for a scientific leadership position of a multidisciplinary cross-functional, in vivo scientific team spanning several disciplines, you should consider acting as a subject matter expert in Cell and Gene Therapy (CGT) and a leader of the study directors in the largest in vivo site of our organization. This role will be responsible for the oversight of scientific operations spanning both tactical planning and strategic vision. 

In this role, you will:

• Provide technical leadership and technical direction for in vivo effectiveness and toxicology CGT studies at preclinical programs.
• Guide and Mentor CGT Study Directors, as well as others, and may serve as Study Director for in vivo CGT studies as needed, especially in client communication and questions.
• Manage scientific expectations of a cross-functional multidisciplinary group of 8 Ph.D. scientists.
• Provide guidance for Study Director in other focus areas
• Recommend and implement techniques to increase productivity, increase efficiency, leverage opportunities, and maintain state-of-the-art processes.
• Works with Quality Assurance department on regulatory updates of GLP requirements as they apply to contracted studies within the organization. 
• Works within the operations and business development team to increase external awareness and exposure of company capabilities for in vivo CGT and complimentary service offerings. 

Experience

• A minimum of 10 years of experience in a GLP-regulated environment in the biotechnology, toxicology, pharmaceutical, or related industries.
• CRO experience is highly desired, and/or experience performing in a setting of managing client deliverables. 
• Experience conducting in vivo GLP studies related to Cell and Gene Therapy
• Experience having taken a drug product or device through pre-IND enabling phases

Education

• (DABT) Board Certification in Toxicology or eligibility is highly desired
• Ph.D. in cell biology, immunology, pharmacology, toxicology, or relevant scientific discipline

This position is a full-time permanent position that requires onsite presence. There can be times when a day or two of working from home is possible close to the location once acclimated to the role.