Associate Director​/Director, Clinical Scientist & Operations; Immunology Early Development

At Hot Spot Therapeutics, nature is inspiring us to create a wave of new medicines. Through a proprietary technology platform, we are uncovering privileged allosteric sites used by nature to control proteins – called regulatory hotspots – that can be exploited through small molecule drug discovery. Regulatory hotspots are allowing sought-after targets to be drugged for the first time while delivering molecules with exquisite selectivity and attractive drug-like properties.

Hotspot is supported by a syndicate of leading healthcare investors based in the US and Europe.

You will be joining a seasoned team of drug hunters with an excellent track record in drug discovery. At Hot Spot, we're not just looking for the brightest minds or for the most brilliant individual contributors. We want passionate team members who are comfortable adjusting their lens, aren't afraid to think big, test bold ideas, and celebrate collective wins. We have established core values that resemble who we are and define our company culture.

We are building a company where values drive everything we do inside and outside the organization:

#Courageous Adventurers #Leave your Mark #Keep it Human #Make it Real

We are seeking a highly collaborative and execution-driven Director, Clinical Scientist and Operations to help shape and advance Hot Spot’s early clinical development programs in immunology. This hybrid role serves as a critical bridge between Clinical Sciences, Clinical Operations, Translational Sciences, and Discovery teams, through hands-on clinical scientist and clinical operations expertise to drive biomarker strategies, clinical study execution, and key program milestones.

Working cross-functionally across the organization and with external partners, the successful candidate will provide scientific leadership, operational oversight, and strategic execution for early-phase clinical studies. As Hot Spot advances pipeline assets into clinical development, this individual will be a key contributor to clinical development strategy with a particular focus on the delivery of clinical biomarker data across the pipeline. This is a unique opportunity to have broad impact across multiple disciplines while helping move novel therapies from development into the clinic.

T he candidate will be responsible for a variety of activities, including but not limited to the following deliverables:

• Provides focused scientific and clinical study support from start-up through clinical study report
• Oversees study enrollment and ensures overall timelines met for key program deliverables and company goals.
• Implements clinical biomarker strategies and oversees all sample activities including collection, testing, storage, and data delivery.
• Contributes to review, interpretation, and communication of accumulating data pertaining to safety and efficacy of molecules under study.
• Ensures adherence to Good Clinical Practice, pharmacovigilance standards, standard operating procedures, regulatory guidelines, and all other quality standards in conducting research.
• Contributes to authorship of regulatory responses and actively participates in meetings.
• Provides project-related education of investigators, study site personnel, CRO partners.
• Responsible for the preparation of Clinical Protocols, Investigator's Brochures (IBs), Informed Consent Forms (ICFs), and Clinical Study Reports (CSRs), including obtaining the input for the development of these documents from the appropriate team members.
• Leads/participates in CRO/vendor selection process for outsourced activities, including the development of scope of services agreements, budgets, plans, and timelines.
• Manages budgets and CRO/vendor agreements, ensuring that change orders and…