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 Clinical Operations leader to play a very significant role in driving our innovative portfolio of novel, small molecule therapeutics in immuno oncology and immunology to the clinic. The successful candidate will be responsible for designing and leading clinical operations initiatives across projects as well as managing external contractors and CROs. This role will have regular interaction with senior management and will be expected to communicate with and influence stakeholders across the company.
- Lead the Clinical Operations organization and provide operational guidance to support short, medium, and long-range program planning
- Support overall set-up, execution, and delivery of global clinical program(s), including clinical development planning, budget management, and resource oversight.
- Lead both internal and external clinical operations activities to ensure the successful conduct of clinical trials in accordance with state/federal regulations, ICH-GCP, clinical study plan(s), SOPs, and other applicable guidelines and regulations.
- Lead the activities of the cross-functional study team as it relates to study-level strategy, budget, timelines, goals, and quality.
- Drive site start-up, subject recruitment, clinical site compliance, clinical monitoring efforts, and site data metrics.
- Communicate and collaborate closely with clinical trial sites to ensure optimal sponsor/site relationships
- Evaluate, select, and oversee all applicable clinical trial vendors (eg, Contract Research Organizations [CROs], central laboratory, etc.) to secure successful clinical trial implementation and execution.
- Coordinate the development of various clinical study documents including informed consent forms (ICFs), operational documents, study reference documents, and site materials. This role will also be responsible for contributing and/or supporting the development of documents including clinical study protocols, Investigator Brochures (IBs), briefing books, annual safety updates, IND submission documents, Health Authority inquiries, and clinical study reports (CSRs).
- Ensure robust risk mitigation plans are developed across the functional organization and program(s).
- Opportunity to work directly with senior management including CEO, Board members, the Head of Operations and Chief of R&D on communicating and assessing trial liability and strategy.
- 10+ years of global trial management experience in a clinical research environment, at least 5 of which should be in industry.
- Strong experience in oncology indications preferred.
- MS/PhD preferred or BS in a science-based subject required.
- Thorough experience in early phase drug development and proven track record of success.
- Multi-dimensional clinical operations background with capability of devising plans for operational challenges such as site activation, patient enrollment, monitoring oversight, protocol deviation management, data cleaning, etc.
- Proficient in engaging with cross-functional teams.
- Thorough command of FDA and ICH-GCP guidelines to ensure the appropriate conduct of clinical studies in the United States, Europe and rest of world.
- Excellent interpersonal, communication, negotiation and influencing skills.
- Experience dealing with significant challenges or accelerations in clinical programs is desirable.
- Outstanding verbal and written communication skills
- Experience in establishing and maintaining relationships with key opinion leaders.