Manager: VP, Biomarker and Bioanalytical Sciences
Department: Pre-Clinical Development
Location: Brisbane, CA or Richmond, CA or remote
Sangamo Therapeutics is a genomic medicine company building value with cutting-edge work across four distinct but complementary technology platforms – gene therapy, cell therapy, in vivo genome editing, and in vivo genome regulation. At Sangamo, we are passionate in developing genomic medicines to transform the lives of patients with serious diseases. We transform lives by building a robust, sustainable, differentiated, innovative, and high value genomic medicine pipeline that addresses patients with life-limiting conditions. Sangamo takes pride in being the first to edit endogenous human genes, first to treat patients with gene edited T cells, and first to treat patients with in vivo genome editing. Our top priority is to meet the needs of patients with commitment and compassion. Sangamo is a company where individuals can flourish, grow and develop their expertise.
Sangamo Therapeutics is seeking a temporary Associate Director/Director of Biomarker Sciences will provide scientific, technical and strategic leadership and oversight of biomarker deliverables and play a pivotal role in supporting Sangamo projects from late-stage research through all later phases of the drug development process. The individual is expected to have strong scientific background and demonstrated expertise in the field of biomarker development. He or she must have excellent interpersonal skills and will work in close collaboration with representatives from research, clinical development, manufacturing and project management groups to implement biomarker solutions and deliver high quality biomarker data.
The position requires adaptability, excellent planning, organization and communication multidisciplinary skills as well as the ability to work in a fast-paced, team-oriented, environment.
We anticipate a 9-month contract assignment.
- Act as a biomarker lead at multidisciplinary project teams, in partner with the clinical team, disease area experts/KOLs to ensure Sangamo gene and cell therapy programs have appropriate and robust biomarker strategies.
- Establish biomarker endpoints into clinical study protocols as primary, secondary, or exploratory endpoints. Select the right tissue/fluid samples, timepoint, collection and processing methods.
- Responsible for executing biomarker plan and deliver biomarker data including diagnostic, pharmacodynamic/response, prognostic and predictive biomarker analysis to support both preclinical and clinical studies.
- Lead the development of companion diagnostics (CDx) to support gene therapy trails in selecting CDx partners, setting up CDx contracts, managing CDx timelines and deliverables, preparing regulatory documents related to CDx developing and filing.
- Drive the identification and validation of biomarkers through implementation of internal and external biomarker activities using targeted or unbiased omics approach.
- Evaluate and implement innovative biomarker technologies to overcome existing challenges and limitations.
- Present scientific data and strategic plans to Sangamo senior leadership or partners, as well as at external conferences and regulatory meetings. Produce original peer-reviewed publications.
- Keep current with changing FDA and EU regulatory requirements for biomarker validation and companion diagnostics.
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
- An advanced degree (PhD, MD, PharmD) in biological sciences such as Immunology, Cell Biology, Biochemistry, Molecular Biology or related filed.
- Minimum of 8 or 10+ years relevant experience in biotech or pharmaceutical industry.
- Strong translational science experience in establishing biomarker strategy, identifying novel biomarker and developing companion diagnostics.
- Previous experience in gene and cell therapy is a plus.
- Excellent writing and editing skills are essential. Experience in preparing documents for inclusion in regulatory submissions including filing of INDs, CTAs and BLAs.
- Good public speaking and presentation skills.
- Ability to build and foster productive collaborations both internally and externally at Sangamo.
- This position can be based in either our Brisbane, CA, Richmond, CA site or remote with periodical travel onsite.
Sangamo is an equal opportunity employer
Sangamo is committed to fostering belonging for all employees and embraces diversity, equity, and inclusion in recruiting and hiring. All qualified applicants for employment are encouraged to apply and will be considered without regard to an individual’s race, color, sex, gender identity, gender expression, religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws
Commitment to Safety
Sangamo requires all U.S. workers to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Sangamo, and it applies regardless of location or classification of role. If you are unable to receive the vaccine & booster, you will have an opportunity to request a reasonable accommodation consistent with applicable laws.
Note to External Recruiters: We do not accept unsolicited resumes from any source other than from the candidates themselves.