Remix launched with a vision to transform patients’ lives through modulation of RNA processing. Our breakthrough science enables the identification of small molecules that influence the expression of disease‑driving mRNAs and proteins. We focus on diseases of high unmet medical need and are committed to operating with scientific rigor and urgency. With a proprietary in‑house technology platform, we have rapidly generated multiple discovery programs advancing toward the clinic. Remix Therapeutics was recognized as one of BioSpace’s Best Places to Work in Boston 2025 and is backed by leading life sciences investors.
Position Summary:
Reporting to the Chief Scientific Officer, the Vice President/Senior Director of Nonclinical Drug Safety and Toxicology is a key position within the R&D leadership team and will lead nonclinical aspects of all the company’s pipeline programs. As the most senior toxicology expert within the organization, the VP will be responsible for providing strategic and operational leadership for the toxicology group across the portfolio of discovery, early development, and late development programs. The Non-Clinical Safety and Toxicology leader will partner cross-functionally across therapeutic areas with colleagues in drug discovery, translational, and clinical development functions, ensuring toxicology and nonclinical safety data is shared and communicated transparently and plays a role in informing strategy at all stages of each program’s development.
Key Responsibilities:
Areas of specific responsibility and attention will include the following:
- Create a long-term global toxicology strategy in alignment with the company’s vision and objectives, including multi-year scientific and operational plans
- Lead scientific direction for global regulatory toxicology including safety pharmacology
- Lead scientific direction for safety assessments of discovery and early development programs, aligning with program objectives and regulatory strategies
- Oversee toxicology findings and provide advice to project teams and senior management on potential impact of results on program goals and probability of success
- Collaboratively design and implement external toxicity studies (in vitro and in vivo) required for lead optimization, and development candidate selection
- Develop strategy, plan and budget to effectively manage regulatory toxicity studies (in vitro and in vivo) required for IND and NDA submissions, including general toxicity, juvenile toxicity, genotoxicity, safety pharmacology, reproductive and developmental, and carcinogenicity studies
- Work with internal R&D leaders and external parties including development partners, consultants, CROs and approved vendors based on a balance of quality, timeliness, and cost
- Develop and manage all timelines related to this function
- Identify and engage experts in the field of toxicology (e.g., consultants) to interpret study results and make recommendations, as needed
- Communicate toxicity study results to discovery program and development teams, and to the company’s executive management and Board of Directors, as needed
- Actively participate in regulatory meetings
- Other duties as assigned
Qualifications:
- PhD in toxicology or related discipline with at least 15 years of experience, (an equivalent combination of experience and education may be considered)
- Preferred 10 years of experience managing and developing a drug safety/toxicology team
- DABT certification strongly preferred
- Experience in defining and implementing scientifically relevant and compliant nonclinical toxicology strategies and contingency plans addressing both theoretical and identified nonclinical safety issues
- Collaborative mindset capable of excelling within multi-discipline discovery and development teams
- Proven track record of interfacing with global regulatory authorities, and the design and interpretation of safety studies for regulatory submissions, including INDs and NDAs
- Deep knowledge of FDA and EMA requirements and guidance for nonclinical safety submissions
- Strong communication (written and oral) and interpersonal skills with an ability to effectively function within a matrixed environment
Salary Range
$293,000 - $358,000 USD
This range reflects the expected base salary for this position, plus bonus, equity, and benefits as applicable. Actual salaries may vary based on factors, such as skill, experience, and qualification for the role.
