Director, Translational Medicine
ImmPACT Bio USA
ImmPACT Bio is a clinical-stage company, headquartered in the Los Angeles area, and with a subsidiary in Israel, developing novel cell therapies for treating cancer. The company’s next-generation chimeric antigen receptor (CAR)-T cell technologies are based on Boolean logic-gate approaches and address key biological challenges for engineered T cell therapies including relapse due to antigen loss/escape; on-target, off-tumor toxicities; and the immunosuppressive tumor microenvironment.
ImmPACT Bio is looking for an exceptional individual to join our growing team as a Director, Translational Medicine. This position will report directly to the Chief Medical Officer and will work with cross functionally with members of the research and process development teams to support both early and late-stage programs. In this role, you will be responsible for the design and execution of clinical trial translational strategies to substantiate mechanistic hypotheses and validate predictive biomarkers of efficacy and safety. In this role, you will support both internal and external scientific activities related to planned registrational studies of novel CAR T cell products as well as future development of next generation cell therapy candidates.
- Design the clinical pharmacology and biomarker strategies for clinical studies
- Manage a team of scientists to execute and report preclinical and clinical research studies to support the clinical development programs in oncology and autoimmunity
- Author relevant sections of clinical and regulatory documents including, but not limited to, briefing books, INDs, protocols, IBs, and BLAs
- Oversee management of key technical contributors to enable delivery of clinical pharmacology data for investigational or registrational studies (PK/PD, ADA, biomarker safety endpoints, etc.)
- Contribute to evaluation, development, qualification, and execution of methodologies for clinical biospecimen analysis
- Identify and establish agreements with vendors and support the transfer and qualification of novel methods
- Write, review, and edit technical documents and study reports
- Aid in the interpretation of clinical trial pharmacology and biomarker data
- Work with Clinical Data Management to incorporate pharmacology and biomarker data in appropriate databases
- Be accountable for timely delivery of high-quality data packages for publication, presentation and/or submission to regulatory agencies
- Contribute to regulatory submissions including IND, Type B and C meetings, and BLA
- Support business development activities and strategic partnerships as a biomarker and diagnostic subject matter expert
- Engage with key opinion leaders for discussions related to biomarker analysis
- PhD or MS degree with demonstrated experience in cell therapy, immunology, cancer biology or a closely related field, and 10 years of industry or academic experience
- Sound scientific track record as demonstrated through authorship of manuscripts and/or congress abstracts in the areas of cell therapy, immuno-oncology, immunology or cancer biology
- Understanding of CAR-T cell pharmacokinetic and pharmacodynamic approaches
- Experience with flow cytometry, multiplexed immunoassay, NGS and PCR
- Experience with clinical biospecimen testing, assay development and method qualification
- Knowledge related to laboratory information management system (LIMS) and electronic lab notebook record keeping (ELN)
- Knowledge related to scientific data analysis applications such as GraphPad Prism, FlowJo, FACSDiva, Spotfire and JUMP software packages
- Demonstrated leadership, organizational and compliant record-keeping skills
- Excellent interpersonal, verbal, and written communication skills are highly desirable in this collaborative work environment
- Comfortable in a fast-paced environment and able to seamlessly adapt to changing priorities
- Self-motivated and ambitious candidate with a strong work ethic
Compensation for the role will depend on several factors, including a candidate’s qualifications, skills, competencies, and experience.
ImmPACT Bio provides a generous Total Rewards package, to include a competitive base salary, bonus, and equity package as well as generous benefits and paid time off programs. ImmPACT Bio is an Equal Opportunity Employer and will review all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. All information will be kept confidential according to EEO guidelines.