The Principal Scientist, Translational Medicine will play an important role in our organization, leading and managing translational biomarker projects, assessing mechanism of action and PK/PD relationships and supporting the translation of drug discovery programs into the clinic. The full-time position reports to the Senior Director, Translational Medicine, and collaborates closely with Discovery, Clinical Sciences, Clinical Pharmacology, Clinical Operations, external collaborators, and CROs.
Responsibilities:
Lead and manage biomarker projects that drive scientific understanding of preclinical and clinical trial data; drive key translational hypotheses for treatment response/non-response; help set the translational research strategy in the autoimmune therapeutic area. Monitor and share progress on project milestones. Analyze, interpret, and present biomarker data cross-functionally and to external stakeholders at meetings and conferences. Work closely with CROs and external collaborators on the development of biomarker assays (eg, immunoassays and flow cytometry panels, as well as close monitoring of study samples. Support review and authoring of translational medicine aspects of clinical and regulatory documents, including development plans, study protocols, laboratory manuals, clinical study reports, regulatory submissions, and responses to any regulatory questions, etc. Function as a scientific thought-leader inside the company and a key link to external scientific and medical literature. Perform all duties in keeping with the Company's core values, policies and all applicable regulations.
Qualifications:
PhD (or MD) in immunology/rheumatology and molecular biology or related field. Fully fluent in written and spoken English. Minimum of 4 years experience in biotech/pharma industry in Biomarker Development. Strong knowledge of the pathogenesis of autoimmune diseases and the application of molecular technologies and models to drive program decisions. Track record of successfully managing projects. Highly organized with strong project management skills including using tools to map deliverables and track progress. Expertise working with CROs to develop immunoassays and flow cytometry panels and managing sample analysis. Excellent oral and written communication skills, including generating high-quality slide decks, technical reports, publications, and oral presentations. Ability to work well with global, multidisciplinary teams. Data analysis and visualization with R or similar. Works independently and thrives in an entrepreneurial, fast-paced, and dynamic work environment. Up to 10% travel. Nice-to-have o Experience with T cell engagers and bispecific antibody therapeutics. o Experience with preclinical biomarkers and models of disease. o Expertise in development and implementation of bioanalytical (PK/ADA) assays. Experience with single cell RNA-Seq and/or immune repertoire sequencing. EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change. To find out more about Real, please visit
