Our Purpose: EMPOWER CELLS TO CHANGE LIVES
At SQZ Biotechnologies we believe that our cell therapies will revolutionize the way we treat diseases. Our unique capabilities enable us to engineer almost any function into any cell type, breaking down the barriers in the field, and creating the possibility for cell therapies that could not have been previously envisioned.
- Patients are the Purpose: We strive to transform patient quality of life so they can focus on living.
- Squeeze Together: We are one team with one goal. Only through the sum of our strengths can we achieve our shared purpose.
- Own the Outcome: We are what we do. Integrity and accountability are fundamental.
- Challenge the Now: We fearlessly drive innovation by questioning what is possible, fostering creativity, and executing on our ideas.
SQZ Biotechnologies is seeking an Associate Director/Director, Translational Medicine to join our Clinical & Regulatory team reporting directly to the Chief Medical Officer. The Associate Director/Director will be responsible for strategic planning and execution of SQZ’s clinical-translational and diagnostic efforts related to the development of cell therapies. The successful candidate will lead the development, documentation, and execution of our immuno-oncology programs. He or she will work in cross-functional teams to assure the highest standards of clinical drug development and GCP.
- Responsible for immunological, genomic and other biomarker aspects of regulatory or communications documents including publications
- Responsible for review of immunological, genomic and other biomarker data of clinical trials
- Responsible for development, implementation and execution of immunological, genomic and other clinical-translational strategies
- Responsible for external data collection and review of competitive intelligence
- Identification and definition of clinical-translational and diagnostic development opportunities
- Recommendation of a translational and diagnostic strategy
- Pharmacodynamic approaches to optimize drug therapy
- Review of translational like immunological, genomic and other biomarker data
- Pharmacogenomic/pharmacodynamic support of safety data review for signal detection
- Author of regulatory or communication documents or sections related to translational medicine or diagnostic and pharmacogenomic strategies
- Monitoring of competitor activities and data
- Implementation and execution of translational, diagnostic and pharmacogenomic strategy
- Provide specific translational, diagnostic and pharmacogenomic expertise to enhance innovation and efficiency in clinical development
- Translational, diagnostic and pharmacogenomic support of Strategic or Clinical Advisory Boards
- Monitoring, coding and data cleaning of translational, genomic, diagnostic and pharmacogenomic data together with Clinical Operations
- Medical writing of translational, genomic, diagnostic and pharmacogenomic sections in regulatory documents not limited to IND submission, IND annual updates, briefing documents, study protocols, investigator brochures and other study-relevant documents like patient informed consent documents
- Timely reporting of translational, genomic, diagnostic and pharmacogenomic data from clinical trials that meet the standards of excellence for ethics, scientific merit, and regulatory compliance
- Input in research activities related to translational medicine
- Manuscript writing of publications or other documents intended for external audiences related to translational, genomic, diagnostic and pharmacogenomic aspects
- Selection of vendors for translational, genomic, diagnostic and pharmacogenomic collaborators and supervision of external collaborators and consultants if applicable
- Function as the internal resource for all functions requiring translational, genomic, diagnostic and pharmacogenomic input
- Be the primary point of contact for clinical trial staff at study sites for translational, genomic, diagnostic and pharmacogenomic issues
- Support of safety charters, DMC charters, or other specific management plans or manuals in a cross-functional team if not primary author
- Support or preparation of translational, genomic, diagnostic and pharmacogenomic data interpretation and clinical trial reports
- Contribute in an active and ongoing manner to the scientific, clinical and commercial development of current and future product candidates
- Medical Affairs activities as needed
- Medical and/or Doctoral degree and post-doctoral training in a field related to Clinical Pharmacology, Translational Medicine, Pharmacology, Pharmacogenomics or Biomarker Research
- At least 10 years of experience in academic, biotech or pharmaceutical setting and experience in translational medicine or biomarker development
- Strong interpersonal, organization, planning and communication (oral and written) skills.
- Extensive knowledge of clinical development, FDA and international global clinical trial regulations and ICH GCP guidelines
- Experience with development of cell and gene therapy products, immuno-oncology therapies and development requirements preferred
- Experience in biomarker and/or genomic-related research in the pharmaceutical/biotech setting
- Must possess an entrepreneurial and hands-on attitude; and be highly self-motivated
SQZ Biotechnologies is proud to be an equal opportunity employer and to provide equal opportunities to all employees and applicants for employment without regard to race, color, religion, sex or gender identity, national origin, age, disability, sexual orientation or genetics. In addition to federal law requirements, SQZ complies with applicable state and local laws governing nondiscrimination in employment.