Lead nonclinical safety strategy and execution for small-molecule programs, design and oversee GLP/non-GLP toxicology and safety pharmacology studies, author regulatory toxicology sections, partner with cross-functional teams and regulatory agencies, and ensure compliance with global guidelines to support IND/CTA and clinical development.
Company Summary:
Atavistik Bio is a privately-held clinical stage biotechnology company accelerating the discovery and development of transformative precision allosteric therapeutics to address serious unmet patient needs. Our proprietary AMPS™ platform allows us to rapidly unlock functional cryptic pockets across a broad range of target classes to accelerate the development of groundbreaking medicines. We have rapidly established an emerging pipeline of allosteric therapeutics with the potential to achieve superior efficacy and tolerability profiles by leveraging the power of allostery.
Atavistik Bio is led by an experienced team of drug hunters with a proven track record of developing marketed small molecule therapies and supported by top-tier investors, including The Column Group, Nextech Invest, Lux Capital, and Regeneron Ventures.
Positions Summary:
We are seeking a passionate and strategic Senior Director, Toxicology, to join our development group and work with an enthusiastic team of highly skilled scientists in a dynamic, high-growth company. Reporting to the Chief Scientific Officer, this individual will be responsible for the design, execution, and interpretation of all nonclinical safety studies to support discovery, IND-enabling, and late-stage clinical development. This person will provide leadership for toxicology across multiple programs, ensuring high-quality data packages to support regulatory submissions. This is a great opportunity to build an efficient Toxicology function while being part of an exciting clinical stage company.
Key Responsibilities:
- Serve as the toxicology subject matter expert on program teams in all stages of drug development, to support decision-making and contribute to overall development strategy
- Work closely with preclinical development team to provide scientific and regulatory toxicology expertise and develop optimal strategies to address specific safety issues
- Partner with Clinical, Regulatory, CMC, DMPK, and Translational Sciences to align nonclinical and clinical development strategies
- Design, oversee, and interpret GLP and non-GLP, investigative toxicology and safety pharmacology studies at multiple Contract Research Organizations to support regulatory submissions
- Support chronic and carcinogenicity studies, reproductive and developmental toxicology, and other specialized studies as required
- Monitor toxicology studies for appropriate conduct, accuracy, and timely execution; review draft reports and ensure quality submission-ready documents for regulatory authorities
- Proactively respond to study issues and resolve problems with study director
- Lead authorship of toxicology and/or safety pharmacology sections of various regulatory documents (e.g., INDs, IBs, CTAs, briefing packages, etc.)
- Represent company at meetings with regulatory agencies related to non-clinical safety
- Prepare verbal and written summaries for internal discussions
- Present summary data to project teams and senior leadership
- Ensure compliance with ICH, FDA, EMA, and other global regulatory guidelines
Required Qualifications:
- PhD in Toxicology or Pharmacology, DVM, or related field
- A minimum of 10 years' experience in the life science industry in a Toxicology or Pathology role and proven track record of conducting preclinical drug safety assessment studies, and ability to make sound risk assessments and represent toxicology perspectives on project teams and with external partners
- Direct experience developing the toxicology strategy and data package supporting the clinical development of small molecule therapeutics
- Demonstrated track record of toxicology leadership on multiple programs at early and late stages of development
- Experience with EMA and FDA CTA/IND submissions and regulatory interactions
- Experience partnering with internal stakeholders and colleagues to ensure comprehensive preclinical safety approaches are developed as part of the program strategy
- Experience working with outsourced studies
- Ability to perform in fast-paced and dynamic environment
- Excellent communication and organizational skills and attention to detail
Benefits:
Atavistik Bio offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care.
Candidate Privacy Notice:
By submitting your resume/CV and any accompanying materials, you acknowledge and consent to the collection, processing, and storage of your personal information for the purpose of evaluating your candidacy, managing the recruitment process, and communicating with you regarding current or future opportunities. Your information may be accessed by authorized personnel and trusted service providers supporting our hiring activities, and will be retained only as long as necessary to fulfill these purposes or as required by applicable law. We will not sell your data, and we will take reasonable measures to protect it from unauthorized access or disclosure. For more information about how we handle applicant personal information, including the categories of personal information we collect, the purposes for which we use it, whether and how we ‘sell’ or ‘share’ personal information as defined under applicable U.S. state privacy laws, our legal bases for processing (where applicable), and your privacy rights, please review our Privacy Policy. By proceeding, you confirm that the information you submit is accurate and that you understand how it will be used.
Atavistik Bio is an equal opportunity employer. All applicants will be considered for employment without regard to a person's race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status, or any characteristic protected under applicable law.
Atavistik Bio Cambridge, Massachusetts, USA Office
Cambridge, MA, United States, 12139
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