Silicon Therapeutics (“SITX”) is a privately-held, physics-driven integrated drug discovery company in the preclinical IND stage targeting innate immunity to start, but with the capability to move into many other franchise opportunities. The Company’s initial pipeline is focused on modulation of the innate immune system to “light the spark” within immunologically cold tumors by using its physics-enabled drug discovery engine for the design of small molecule therapeutics and the lead program is in late stage preclinical studies. SITX’s discovery efforts as well as physics-based platform are all completely in-house, with a full wet lab as well as a team of over 25 experienced R&D professionals spanning biology, biochemistry, chemistry, biophysics (NMR + X-ray) & preclinical sciences. SITX’s engine leverages quantum mechanics and molecular dynamics, which are deployed on its own internal super computer composed of over 400 GPU’s and FPGA’s and allows SITX to accurately simulate the physical motion and properties of biological targets at an atomistic level resolution. The platform is completely proprietary to SITX and was built from the ground up with the purpose of addressing difficult targets and using simulations to break through bottlenecks that has plagued traditional drug discovery approaches on such targets. It is currently the ONLY company which owns the entire spectrum of physics-driven drug discovery from chip-to-clinic with a team of over 40 individuals in Boston.
The Company’s initial focus in on innate immunity and its pipeline is currently composed of one project entering into IND-enabling studies, another one entering hit-to-lead and two more ramping up. It’s unique advantage in designing small molecules using all atom simulations has allowed it to advance a systemically available small molecule STING agonist into a preclinical development. The program is ramping up for IND enabling studies entry to the clinic in 2020. This differentiated product can be administered systemically via an IV dose and has single agent effects in early mouse efficacy studies using PD1 resistant tumor models and is a “rule-of-5” compliant small molecule. Beyond this one program, the Company is also advancing an ADAR inhibitor which can be considered an innate immune check-point as well as a multitude of targets that explore Innate Immunity’s role in cancer biology.
Silicon Therapeutics is seeking an innovative, experienced and motivated translational medicine leader to spearhead the design, development and execution of biomarkers programs to support the development of our novel, small molecule therapeutics in immuno oncology and immunology. The successful candidate will work closely with the discovery team, internal and external medical leads as well as other relevant functional areas including DMPK, Clinical Operations and Regulatory to translate research-phase biomarker assays (for PD, MoA, patient stratification) into qualified, validated clinical trial assays.
- Selection of biomarkers to drive clinical decision making including on-target PD and distal mechanistic assays from circulation and biopsy tissues using protein, nucleic acid and cell based-assays.
- Convert discovery phase biomarker assays into validated fit-for purpose clinical trial assays
- Work closely with discovery scientists and development teams to develop and deliver on integrated translational plans to support programs from the preclinical stage through clinical PoC.
- Select and oversee work of CROs for execution of clinical trial assays
- Transfer internally developed preclinical assays to CLIA/other settings to develop final fit-for-purpose clinical trial assay
- Oversight of execution on assay deliverables with respect to quality, timelines and budget, within internal lab as well as external partners
- Develop and implement SOPs for sample acquisition, storage and transfer of materials at clinical trial sites and train staff on work flow and coordination with CRO assay lab or internal lab
- Work with statisticians, develop rigorous data analysis to turn data into actionable insights to inform clinical development
- Contribute to submissions and communication with regulatory authorities
- Present data and insights from Translational Medicine internally, to partners, at scientific conferences and in publication form.
- Ph.D., M.D. or equivalent and 7+ years of experience in pharma or biotech in biomarker ID, assay development and clinical implementation
- Strong subject matter expertise in oncology biology, working knowledge of immune targets
- Successful track record of developing and executing on a biomarker plan from preclinical stage to clinical assay implementation on cross-functional teams
- Experience in selecting and managing vendors/CROs to deliver and execute on clinical biomarker assays
- Proven effectiveness in working in team-oriented, face-paced setting
- Track record of innovation in problem solving in translational medicine/sciences
- Experience in establishing and managing external academic research collaborations
- Excellent communication and collaboration skills
- Experience in authorship of regulatory filings
- Strong technical background in protein-based biomarker technologies (e.g. Western blot, ELISA, Luminex, Meso Scale), nucleic acid (RT-qPCR, RNAseq, NanoString, Droplet digital PCR), cell-based (flow cytometry, ex vivo functional assays) and tissue-based assays (IHC, Mass spectrometry).