Director, Nonclinical Bioanalytical Sciences

Location
South San Francisco, California
Posted
Jul 01, 2021
Ref
Req# 2147
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time

Encoded Therapeutics Inc. is a biotechnology company advancing precision medicines for pediatric CNS disorders. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery. We focus on delivering life-changing advances for individuals with genetic disorders not addressable with current approaches. For more information, please visit www.Encoded.com.

Encoded is seeking a Director of Bioanalytical Sciences to provide scientific leadership in nonclinical biodistribution and dose-determining biochemical studies in the development of gene therapy products. This position reports to VP, Translation Sciences. The successful candidate will be a scientific leader that can expand our assays and methods to develop our understanding of in vivo vector biodistribution and transgene expression profile for gene therapy product and contribute to interpretation of nonclinical pharmacology and toxicology studies to support clinical development programs.

Ideal candidate will be enthusiastic, entrepreneurial scientist motivated to shape the development of gene therapy products. The successful candidate will have opportunities to drive innovation and scientific excellence, make meaningful contributions to the nonclinical development of gene therapy product pipeline. This position will work in collaboration with Regulatory, Preclinical and Clinical Development groups, and will be responsible for integrating evolving regulatory guidance and latest technological advances from the gene therapy and other fields towards development of gene therapy products for neurological indications with significant unmet need.

Responsibilities:

  • Contributes to the development and execution of bioanalytical studies for candidate gene therapy products, throughout the drug development lifecycle
  • Provide high quality analytical assessments for tissue biodistribution and mRNA expression profiles with sensitive quantitative molecular biology tools like qPCR, digital droplet (dd)PCR, RT-ddPCR and other pertinent platform technologies.
  • Drive development of sensitive and robust protein detection methods to detect and quantify tissue transgene protein expression profiles using biochemical methods like electrochemiluminescence (ECL)-based Immune assays on MSD platform, Luminex, mass spectrometry approaches and other technologies.
  • Scientifically oversee the design, development, timely execution, analysis, interpretation, and reporting of vector biodistribution, viral vector shedding studies along with transgene RNA and protein expression studies in POC preclinical studies as well as definitive, FIH-enabling pharmacology and biodistribution studies in preclinical models
  • Provide scientific monitoring and guidance on outsourcing studies for method transfer, troubleshooting, qualification and validation studies to support gene therapy development
  • Succinctly and effectively communicate interpretations of nonclinical molecular biodistribution and biochemical studies in writing and verbally, internally and externally, including for regulatory submissions for pre-submission (e.g. pre-IND), scientific advisory fillings and IND or CTA meeting related briefing books
  • Stay updated with knowledge of regulatory agency nonclinical and gene therapy regulations/guidelines, and relevant scientific literature and evaluate implications for internal studies
  • Hire, develop, and retain key scientific talents and provide training opportunities and mentorship to further develop a high functioning bioanalytical team
  • Drive to ensure that the activities of the team follow record management, resource management, vendor management best practices and maintain a culture of continued process improvement.
  • PhD in Biochemistry, Molecular Biology or equivalent
  • 8+ years experience including industry including postdoctoral work in fast-paced environments
  • Track record in the form of publications and lead roles in drug development programs
  • Depth of experience in AAV gene therapy or related genetic therapies is essential.
  • Broad knowledge and background in central nervous systems is a plus.
  • Strong ability to work in a matrixed, collaborative, and goal-oriented environment. Effectively and transparently manage multiple projects and resources to achieve goals
  • Extensive knowledge in conducting molecular assays for DNA and RNA measurements with qPCR, digital droplet PCR, Reverse transcription-PCR methods in a variety of biological matrices. Familiarity with high-throughput nucleic acid purification platforms like KingFisher and sample quality systems like Bioanalyzer and TapeStation
  • Deep analytical abilities to analyze, graph and complete statistical analysis of large-scale data sets using Excel, JMP, GraphPad Prism software programs.
  • Strong bioanalytical skills and familiarity with approaches and methods to allow sensitive and robust quantitation of tissue expressed transgene protein including mass spectrometry methods
  • Proficiency and practical knowledge of method development, troubleshooting, qualification and validation in accordance with regulatory guidelines
  • Outstanding communication, presentation, and writing skills
  • Personnel characteristics of integrity, teamwork, and commitment to excellence to fit with Encoded core values for success
  • Comprehensive benefits package, including competitive employer premium contributions
  • Meaningful stock option grants
  • PTO, sick time and holiday pay
  • Generous Parental Leave program
  • Pre-tax medical and dependent care programs
  • STD, LTD, Life and AD&D
  • Professional development opportunities
  • Team-building events
  • Fully stocked kitchen
  • Purple Tie dry cleaning service
  • Fitness center

Encoded is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Encoded is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Encoded are based on business needs, job requirements and individual qualifications, without regard to race, religion or belief, color, national origin, gender, status as a protected veteran, status as an individual with a disability, or any other status protected by the laws or regulations in the location in which we operate. Encoded will not tolerate discrimination or harassment based on any of these characteristics. Encoded encourages applicants of all ages.

If you need assistance or an accommodation due to a disability, you may call us at +1 650-491-0272.