Director, Nonclinical Regulatory & Quality
Recursion Pharmaceuticals
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The Impact You’ll Make
Recursion is at the forefront of reimagining drug discovery and development through broadening the funnel of potential targets, using technology and standardization to build connected data, and superlinearly scaling our efforts to accelerate the delivery of high-potential drug candidates to the clinic. We are seeking a Director of Nonclinical Regulatory & Quality who will be responsible for the overall regulatory and quality strategy of preclinical activities, including in vivo studies, in vitro testing, and data management. This includes developing and implementing quality assurance standards (both internally and externally), leading nonclinical regulatory strategies that align with company objectives and evolving regulatory standards, and addressing quality, regulatory and compliance risks across the preclinical portfolio. In this role, you will:
- Streamline and industrialize the advancement of programs from discovery to clinical. You will drive strategic and innovative approaches to advance preclinical programs through discovery, IND-enabling, and clinical stages. You will identify and lead opportunities to automate and improve efficiency within the regulatory submission process. You will create report guidelines that standardize how graphs, figures, and calculations are reported to align with submission standards.
- Develop and drive regulatory strategy for our novel nonclinical programs. You will integrate with Discovery, Translation, and Clinical to guide nonclinical regulatory strategy in alignment with Recursion’s overall regulatory strategy and ensure appropriate studies are conducted to support our platform-enabled late-discovery programs and ongoing clinical-stage programs. You will work with technical stakeholders and fellow Regulatory colleagues to prepare and review regulatory submission documents that highlight our unique approach to drug discovery and align with regulatory standards. You will be responsible for the quality and effectiveness of nonclinical sections of regulatory submissions.
- Establish and embed quality principles into nonclinical activities. You will collaborate with colleagues and stakeholders to define good research principles and establish data and documentation standards for laboratory notebooks and nonclinical study reports to ensure integrity of data. You will develop and implement phase appropriate training and provide guidance and support to nonclinical stakeholders to embed a culture of quality.
- Guide and scale high-quality execution of nonclinical studies. You will collaborate with technical stakeholders to assess current and potential CROs for capabilities and adequate quality systems. You will work directly with CROs to establish clear communication and quality expectations, including documentation/reporting requirements. You will monitor the conduct and reporting of nonclinical studies to improve quality and minimize unacceptable risks.
Location:
Making Salt Lake City your home base is ideal, however, we will consider remote employees for this position. We ask that remote employees commit to regular (at least once per quarter) on-site visits for routine work and departmental events.
The Team You’ll Join
Reporting to the Head of Regulatory & Quality, you’ll lead the Nonclinical RA/QA function within the Regulatory & Quality department. As the Nonclinical RA/QA representative on this diverse team, you’ll work collaboratively with fellow team members and stakeholders from toxicology, pharmacology, translational research, chemistry, and biology to support nonclinical programs (including late discovery, IND-enabling, and clinical-stage assets) in alignment with Recursion’s regulatory strategy.
The Experience You’ll Need
- Minimum Master's degree in life sciences or a relevant field, such as regulatory science
- Minimum 8 years’ experience in the pharmaceutical industry, with a strong knowledge of nonclinical toxicology and pharmacology
- In-depth knowledge of good research principles and applicable regulations/guidance documents relevant to nonclinical activities in the US, EU, UK, and emerging markets
- Experience preparing nonclinical regulatory dossiers/submissions and interacting with health authorities
- Experience qualifying, monitoring, and partnering with third-party providers (e.g., CROs)
How You’ll be Supported
- Participation in cross-functional and project-based meetings provide opportunities to integrate up front
- Regular 1:1s with supervisor and colleagues provide opportunities for support and feedback
- Training on Recursion’s culture and values and our Drug Discovery & Development processes to provide insight to our unique approach and strategy for success
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The Values That We Hope You Share:
- We Care: We care about our drug candidates, our Recursionauts, their families, each other, our communities, the patients we aim to serve and their loved ones. We also care about our work.
- We Learn: Learning from the diverse perspectives of our fellow Recursionauts, and from failure, is an essential part of how we make progress.
- We Deliver: We are unapologetic that our expectations for delivery are extraordinarily high. There is urgency to our existence: we sprint at maximum engagement, making time and space to recover.
- Act Boldly with Integrity: No company changes the world or reinvents an industry without being bold. It must be balanced; not by timidity, but by doing the right thing even when no one is looking.
- We are One Recursion: We operate with a 'company first, team second' mentality. Our success comes from working as one interdisciplinary team.
Recursion spends time and energy connecting every aspect of work to these values. They aren’t static, but regularly discussed and questioned because we make decisions rooted in those values in our day-to-day work. You can read more about our values and how we live them every day here.
More About Recursion
Central to our mission is the Recursion Operating System, or Recursion OS, that combines an advanced infrastructure layer to generate what we believe is one of the world’s largest and fastest-growing proprietary biological and chemical datasets and the Recursion Map, a suite of custom software, algorithms, and machine learning tools that we use to explore foundational biology unconstrained by human bias and navigate to new biological insights which may accelerate our programs. We are a biotechnology company scaling more like a technology company. Recursion is proudly headquartered in Salt Lake City.
Learn more at www.recursion.com, or connect on Twitter and LinkedIn.
Recursion is an Equal Opportunity Employer that values diversity and inclusion. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, local, or provincial human rights legislation.
This job is no longer accepting applications
See open jobs at Recursion Pharmaceuticals.See open jobs similar to "Director, Nonclinical Regulatory & Quality" Lux Capital.