Associate Director, Toxicology (Remote)

As the Associate Director, Toxicology at Nurix Therapeutics, you will lead the toxicology strategy for drug development, ensuring the assessment of human risks associated with novel therapeutic targets. Key responsibilities include managing safety pharmacology studies, collaborating with expert teams, and contributing to regulatory filings. Your leadership will shape the direction of multi-disciplinary programs and promote effective communication of toxicology results.

To qualify for the Associate Director position at Nurix Therapeutics, candidates must possess a Ph.D. in Toxicology, Pharmacology, or a related discipline, alongside a minimum of 5 years in the industry or FDA experience. Substantial nonclinical development experience is critical, particularly familiarity with designing, monitoring, and interpreting safety pharmacology studies and interactions with regulatory agencies.

Ideal candidates for the Associate Director role at Nurix Therapeutics should have considerable experience in nonclinical development within the pharmaceutical or biotechnology sectors, or with the FDA. Experience in regulatory submissions and a deep understanding of toxicology and safety pharmacology are crucial for succeeding in this position, as you'll be responsible for high-stakes regulatory documentation and study protocols.

At Nurix Therapeutics, compliance in toxicology studies is maintained through vigilant monitoring of outsourced GLP and non-GLP studies. As an Associate Director, you will ensure adherence to protocol, regulations, and safety guidelines, working closely with partners and staff to uphold the highest standards in research integrity and regulatory compliance.

The Associate Director, Toxicology position at Nurix Therapeutics offers substantial opportunities for career advancement. By leading critical toxicology efforts and engaging in high-level regulatory interactions, you'll develop essential skills and leadership abilities that can lead to senior management roles, shaping the future of biopharmaceuticals and contributing to groundbreaking treatments.

When designing nonclinical toxicology studies, I focus on aligning our objectives with regulatory expectations. I ensure the study protocols incorporate the latest scientific insights and are tailored to assess specific safety and efficacy concerns while coordinating with multidisciplinary teams to gather comprehensive data.

I once led a toxicology study where we encountered unexpected safety signals. I coordinated with the project team to conduct a root cause analysis and adjusted our study parameters, resulting in a successful regulatory submission that clarified our drug's safety profile.

I emphasize proactive communication, establishing clear timelines and deliverables at the outset. Regular meetings and updates help maintain alignment on study progress and preemptively address any potential issues.

I have extensive experience preparing various regulatory documents, including INDs, CTAs, and BLAs. My focus has always been on delivering high-quality, data-driven submissions that effectively communicate our findings to regulatory agencies.

I have had the opportunity to interact with FDA officials during regulatory submissions. I approach these interactions with thorough preparation and transparency, ensuring we address any questions efficiently and present our data convincingly.

I regularly attend industry conferences, engage with professional networks, and read leading journals to remain informed on the latest advancements and regulatory changes impacting the field of toxicology.

In my previous role, I prioritized multiple toxicology studies by conducting a thorough analysis of each project's timelines and resource requirements. By implementing a risk-based approach, I ensured that the most critical studies received the attention needed to meet our goals.

When I encounter discrepancies in study data, I first engage my team to investigate the root cause. I prioritize thorough documentation and analysis to address the issues while maintaining an open line of communication with stakeholders about any adjustments to our conclusions.

Toxicology plays an essential role in drug development by identifying potential safety risks early in the process. It informs decision-making and development strategies, ultimately ensuring that only safe and effective therapies progress to clinical trials.

I value mentorship and focus on providing junior team members with hands-on training, regular feedback, and opportunities to participate in meaningful projects. This fosters their professional growth and enhances our team's overall effectiveness.