Associate Director/Director, Toxicology

Full-time role based in Boston, MA or Monmouth Junction, NJ

About HotSpot Therapeutics, Inc.

Within every human cell, nature has engineered finely-tuned control mechanisms to correct imbalances caused by stress and disease and promote healing.  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. As a HotSpotter, you are comfortable thinking outside the box and breaking convention. You are curious about the world and contribute beyond your precise role description. You are action orientated and extraordinary at getting things done. You communicate openly with your colleagues, and you hate office politics.

As HotSpot Therapeutics moves pipeline assets into early clinical development, the Associate Director/Director, Toxicology will be a key leader and contributor to our nonclinical development strategy with a focus on delivery of comprehensive and robust safety assessments.

The successful candidate will be a hands-on leader in the toxicology field with experience developing and implementing nonclinical safety assessment strategies for small molecule drugs directed against both oncology and immunology targets in early clinical development.

RESPONSIBILITIES

• Develop and lead the toxicology strategies for HotSpot pipeline assets in oncology and immunology; supporting various Discovery teams and Nonclinical Development
• Formulate solid safety assessment plans and design toxicology studies by integrating target biology and clinical candidate properties (PK, pharmacology, biomarkers) with toxicology essentials
• Ensure readiness of cross-functional necessities (including API, PK, formulation, clinical candidate potency across species) by working with discovery teams and CMC to enable operational feasibility of toxicology studies
• Monitor toxicological studies and communicate with each study director to execute the safety assessment and then synthesize and communicate integrated toxicology findings to key stake holders in a timely manner to facilitate decision making
• Author IND summaries and interact with various regulatory bodies
• Identify and/or build new technologies important for longer-term success including novel toxicological tools/models for the safety assessment.

QUALIFICATIONS

• Ph.D. in pharmacology/toxicology (or close equivalent) with at least 4-8 years of experience in pharma/biotech industries
• Strong scientific track record in toxicological field; DABT preferred but not required
• Working knowledge of regulatory guidelines and toxicology strategies for small molecule drugs
• Hands on experience in IND filings and regulatory interactions
• Experienced in working with external CROs is a strong plus
• Proficient in oral and written communications
• Ability to work independently and in a cross-functional team setting; including colleagues across R&D and many CRO/CMO partners
• Amenable to multitasking and prioritizing with good flexibility under fast pace; willing to do both high level and hands-on work

At HotSpot, we have a bold mission to establish a new drug discovery and development paradigm. If this appeals to you, please let us know at [email protected]

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