Senior Scientist, Translational Gene Therapy Lead
South San Francisco, California
Our client is seeking an experienced Translational Medicine Lead with a deep understanding of gene therapy and regulatory agency requirements. The ideal candidate will have preclinical experience in the field of gene therapy and be able to lead the development of products from the research stage through to clinical trials. The role will involve working closely with cross-functional teams to ensure the successful development of gene therapy products that meet regulatory standards and effectively translate scientific discoveries into clinical practice.
What you will accomplish
- Manage the development of multiple projects, ensuring they are executed withing the established timelines.
- Communicate effectively with Key Opinion Leader (KOLs) to maintain up to date understanding of the literature.
- Develop strategies for preclinical development, including the identification and management of risks and opportunities.
- Collaborate with cross-functional teams, including R&D, Clinical and CMC.
- Help prepare regulatory submissions and participate in meetings with regulatory agencies as needed.
- Act as a program manager and facilitate project documentation, ensuring all necessary documentation is complete, accurate and up-to-date.
Qualifications
- Ph.D. or equivalent in medicinal chemistry, pharmacology, or related discipline, with a minimum of 5 years of related experience in biotechnology or pharmaceutical industry
- Demonstrated experience working with regulatory agencies, including leading interactions with FDA, EMA, and/or other relevant agencies.
- Strong preclinical experience in gene therapy.
- Experience in designing and overseeing preclinical studies and interpreting preclinical data.
- Demonstrated ability to work with CRO and to collaborate with cross-functional teams and external partners, including regulatory agencies, academic institutions, and biotech companies.
Technical Requirements and Skills:
- Understanding of gene therapy and CRISPR based technologies.
- Strong communication skills, with the ability to effectively present scientific data and communicate complex scientific concepts to a wide range of stakeholders.
- Strong analytical and problem-solving skills, with the ability to effectively identify and address complex scientific and regulatory issues.
- Ability to work in a fast-paced environment, manage multiple projects, and meet deadlines.
The salary range for this position is $140,000.00 – $168,000.00 USD annually. This salary range is an estimate, and the actual salary may vary based on various factors, including, without limitation, individual education, experience, tenure, skills, and abilities, as well as internal equity and alignment with market data, including potential adjustments for geographic location.