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.
SITX was founded out of the BIDMC in late 2016 and has raised ~50mm USD to date from leading investors including Sequoia & Chengwei Capital. The Company’s investors are long-term, premier brands that have the capability to hold businesses for decades and are believers in SITX’s mission and physics-driven approach.
As a member of the Silicon Therapeutics’ Regulatory team, the Regulatory Manager will support programs with major filings (INDs, NDAs, MAAs) and will work collaboratively with cross functional teams to support development milestones. The Regulatory Manager will also be responsible for managing CROs responsible for Ex-US clinical trial applications including driving submission strategies and timelines, reviewing and approving submission components, and working with program teams to create or obtain required submission documents. The Manager will also take a leadership role in establishing internal regulatory tracking systems and archiving systems and developing regulatory SOPs. The ideal candidate will be a motivated self-starter who thrives in a fast-paced, small team dynamic environment.
- Compile and manage regulatory submissions for assigned projects
- Responsible for supporting active INDs and CTAs including planning for and coordinating IND maintenance submissions, managing CROs responsible for clinical trial applications outside of the US and responding to questions
- Support external regulatory consultants, and contribute to the development and implementation of CMC, nonclinical, and clinical regulatory strategies for projects in all stages of development (pre-IND through commercial) for assigned projects
- Support preparation for Health Authority interactions including preparing meeting requests and briefing books
- Responsible for developing or contributing to the development of project timelines and the planning of regulatory milestones
- Contribute to the continuous improvement of existing department processes and strategies
- Maintain regulatory archives and submission trackers
- Contribute to and develop regulatory SOPs
Required Skills & Qualifications
- BS with 5+ years of related experience; MS with 2+ years of experience.
- Demonstrated experience in contributions to early stage filings (IND preferred)
- Strong computer skills, Excel, Word and PowerPoint.