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.
Reporting to the CEO, Lanny Sun, the Chief Medical Officer will lead the entirety of the Company’s regulatory & clinical development efforts through the pursuit of innovative trial design and effective development strategies with the goal of rapidly advancing lead drug candidates while also providing clinical input into major strategic decisions such as Target selection, business development, financing and commercial execution, etc. The position will build and lead functional components in support of product development and partnering strategies including clinical development, translational research, biostatistics, medical writing, clinical operations, regulatory/safety and pharmacovigilance. The CMO will serve as a key member of the Executive Team, and must be able to completely own the executive spectrum of clinical development from strategic planning and tactical execution, management to communication with investor/Directors of the Board, and will act as the primary spokesperson for SITX’s clinical development strategy, internally and externally.
The essential functions and responsibilities of the CMO will include but are not limited to:
- Establish and drive a clinical and translational strategy to support the development of SITX’s pipeline and be among the first to explore innate immunity’s role in cancer within a clinical setting
- Build from scratch and manage a fully loaded clinical development team including bench-to-bedside translational medicine, regulatory affairs, medical affairs, clinical development, clinical operations, biomarker analysis, etc
- Represent SITX at the highest levels of the FDA and other regulatory agencies.
- Maintain a current understanding of the competitive landscape and any developments in relevant therapeutic areas
- Work closely with the CEO to pace financing and strategy to key clinical value inflection points and risk-mitigating milestones; assist with all aspects of fundraising as it relates to clinical strategy
- Work closely with the Chief of R&D to provide clinical input on key innate immune target selection decisions and Target Product Profile decisions / designs; ensuring that findings from the clinic and translated BACK into target selection and TPP designs as well as forward
- Work closely with Chief of R&D and CSO to explore new franchise opportunities which leverage our unique physics-based engine
- Establish and maintain working relationships with the global scientific/clinical communities, academia, government, key opinion leaders and lead clinical investigators
- Assist in securing alliances with pharmaceutical company partners to enhance/expedite the development of the Company’s assetsQualificationsSITX’s CMO will be an exceptional physician/scientist with a depth of experience leading oncology drug discovery and development. Whether a M.D./Ph.D. or M.D. candidate, this individual will embrace and have a genuine passion for all aspects of the science with complementary experience leading oncology-focused translational and clinical development organizations. A successful record of taking promising oncology compounds from preclinical development through the clinic, this individual will possess deep insight into the subtleties of small molecule pharmacokinetics and dosing regimens. Earlier tenures will ideally include a mix of larger pharmaceutical and high-growth biotechnology exposure or an innovative pharmaceutical setting to ensure his/her transition into a fast- paced, entrepreneurial environment.The ideal executive will be passionate about developing novel therapeutics and successful outcomes for patients, and excited about the potential of innate immunity within the context of turning “cold” tumors hot. To this end, the candidate will approach the CMO mandate with a 24/7 mindset to ensure the implementation of the Company’s programs and will bring a high energy approach to the role, as well a readiness to take on the heavy lifting often required in a biotechnology setting. The CMO will be equally passionate about oncology drug development and the potential for SITX’s novel approach. Given the unprecedented prospect of this opportunity, a successful candidate will be able to establish a case for assuming the CMO role and leading the medical function at SITX.
Key qualifications include:
- M.D. requirement and preference for an M.D./Ph.D. with a proven record of leading oncology translational and clinical development programs in a biopharmaceutical industry setting
- Experience with both biomarker driven, smaller focused trials as well as comfort with larger studies
- Significant record of developing, planning, designing and executing clinical protocols ideally leading to the successful registration of therapeutics.
- Familiarity and experience with immune oncology and this new class of drugs altering the landscape in cancer treatment.
- Highly collaborative across multiple functional areas including chemistry, biology, and pharmacology.
- Ability to lead, inspire and coach oncology physicians and scientists toward the optimization of clinical operations.
- Strong acumen and decision skills as applied to critical go/no-go decisions in the pre-clinical to early stage clinical process.
- Ability to think creatively and strategically about novel clinical trial design.
- FDA regulatory submission and global regulatory agency experience, including interaction on innovative trial designs and new indications.
- Exposure and understanding of ancillary functions including biostatistics, regulatory and safety/pharmacovigilance, and medical affairs.
- Experience selecting and managing external vendors and outsourcing partners.
- Highly developed understanding of external market place and scientific literature.
- Record of building/ leading high-performance teams to success.
- Ability to communicate complex scientific narratives internally and adapt to external stakeholders and audiences.
- Record of developing positive relationships across all levels of the organization and with Board of Directors.
- Recognized for unquestionable integrity and highest ethical standards.
- Strong relationships with leading KOLs, PIs and study sites