Associate Director/Director, Clinical Scientist & Operations (Immunology Early Development)

HotSpot Therapeutics, Inc.; Boston (MA); Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Competitive salary and bonus plans

Comprehensive benefits package

Generous paid holidays and time off

Supportive team environment

Job summary

HotSpot Therapeutics, Inc. seeks a highly collaborative Director, Clinical Scientist and Operations to shape early clinical development programs in immunology.

This hybrid role bridges Clinical Sciences, Clinical Operations, Translational Sciences, and Discovery—driving biomarker strategies, study execution, and key program milestones. In this position you will provide scientific leadership, oversee CROs and clinical sites, ensure safety and data integrity, and contribute to regulatory

Qualifications

• 10+ years of clinical development and/or operations experience in pharma/biotech.
• Strong scientific track record in Immunology.
• Experience managing external CROs, central labs, and clinical sites.
• Cross-functional collaboration skills in a fast-paced setting.
• Excellent oral and written communication; able to balance strategy and hands-on work.

Responsibilities

• Provide scientific and clinical study support from start-up through CSRs.
• Oversee study enrollment and ensure timelines and goals are met.
• Lead clinical biomarker strategies and data delivery from samples.
• Interpret safety/efficacy data and communicate findings.
• Ensure adherence to GCP, regulatory guidelines, and quality standards.
• Contribute to regulatory responses and meetings.
• Educate investigators, site personnel, and CRO partners.
• Prepare protocols, IBs, ICFs, and CSRs with cross-functional input.
• Lead CRO/vendor selection, budgets, plans, and timelines.
• Manage budgets and vendor agreements; ensure compliant change orders.
• Implement clinical trial operational plans; develop CRFs, EDC, IRT training.
• Review data completeness and maintain data fidelity in study conduct.

Education

Bachelor's Degree in biology/immunology

Master’s degree in related field

Advanced degree preferred

Job description

At HotSpot 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 HotSpot, 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

SUMMARY:

We are seeking a highly collaborative and execution-driven Director, Clinical Scientist and Operations to help shape and advance HotSpot’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 HotSpot 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:

RESPONSIBILITIES:

• 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 budgets meet clinical operations specifications.
• Ensures successful implementation of clinical trial operational plans.
• Contribute to creation of Case Report Forms (CRFs), electronic database, IRT, and associated training documents. Review data completeness and ensure data fidelity throughout study conduct.

QUALIFICATIONS:

• Bachelor’s Degree in biology, immunology, or related life sciences discipline with 10+ years of relevant clinical development and/or operations experience in pharmaceutical and/or biotech industries; or a Master’s degree in a related field with 8+ years of relevant industry experience. Advanced degree preferred. Experience in a start-up environment is a plus.
• Strong scientific track record in the Immunology Therapeutic Area
• Hands on experience working with and managing external CROs , central labs, and clinical sites
• Ability to work and collaborate in a cross functional team setting
• Proficient in oral and written communications
• Demonstrated ability to manage multiple priorities in a fast-paced environment while balancing strategic thinking and hands‑on execution.

OUR BENEFITS:

We believe that people are our greatest resource and foster a supportive environment that provides growth and development for all teammates. We recognize and reward performance and incentivises long‑term success. From benefits that focus on your health and well‑being to competitive compensation to ownership in the company, we want to inspire our employees.

Our Benefits Include, But Are Not Limited To:

• Competitive salary and bonus plans
• Comprehensive package of benefits plans and fringe benefits
• Generous paid holidays, time off, including 2 company wide shutdowns
• Amazing team of supportive colleagues

HotSpot is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

At this time, HotSpot is not able to offer Visa sponsorship for this position. Candidates must be authorized to work in the United States without current or future sponsorship.