Korsana Biosciences is a private biopharmaceutical company advancing a pipeline of potential best-in-class therapies for neurodegenerative diseases. In partnership with Paragon Therapeutics, we have developed Therapeutic Targeting (THETA™), a novel blood-brain barrier-penetrant shuttle platform designed to enable dramatically higher drug concentration inside the brain and overcome the limitations of earlier shuttle technologies. Our lead program is KRSA-028, an investigational, shuttled antibody targeting amyloid beta designed to be a best-in-class treatment for Alzheimer’s disease. Our mission is to advance precision-engineered therapies, designed to address some of the biggest unmet needs in medicine. For more information, please visit www.korsana.com.
Location: Remote or Boston Metro – Hybrid
Position Overview
We are seeking an experienced and highly motivated Associate Director / Director of Preclinical Toxicology to lead and oversee all preclinical toxicology activities for our drug development programs. The ideal candidate will have deep expertise in preclinical toxicology, a solid understanding of drug development, and experience advancing novel therapeutics from discovery through preclinical stages. This individual will be responsible for designing and executing preclinical safety strategies, overseeing toxicology studies, and collaborating with internal teams and external CROs to ensure safe and effective development of new therapeutics.
The successful candidate will have a proven track record in preclinical toxicology and a deep understanding of the regulatory and scientific principles underpinning drug development.
Responsibilities
Preclinical Toxicology Strategy and Oversight:
- Develop and implement the preclinical toxicology strategy for early-stage drug candidates, ensuring alignment with the overall drug development pipeline and regulatory requirements.
- Oversee the design, execution, and interpretation of preclinical toxicology studies (GLP and non-GLP), including safety pharmacology, single-dose and repeat-dose toxicity, genotoxicity, carcinogenicity, and reproductive toxicity studies.
- Ensure toxicology studies support IND filings, regulatory submissions, and clinical trial design.
Collaboration with Internal and External Teams:
- Work closely with cross-functional teams to assess preclinical safety data and inform decision-making on candidate selection and progression.
- Lead the strategic planning and execution of preclinical safety programs in collaboration with internal teams and external Contract Research Organizations (CROs).
- Partner with regulatory affairs to prepare safety data for regulatory submissions, including IND filings and responses to regulatory inquiries.
External CRO and Vendor Management:
- Manage and oversee external CROs and toxicology contract research organizations to ensure timely execution of studies, adherence to GLP standards, and regulatory compliance.
- Ensure the identification and management of key CRO relationships to advance preclinical toxicology programs efficiently.
- Review and approve toxicology study protocols, reports, and deliverables from external partners to ensure scientific rigor and quality.
Regulatory and Clinical Development Support:
- Provide strategic leadership to the clinical development team on the safe translation of preclinical toxicology data into clinical trial designs and contribute to the development of clinical risk assessments.
- Collaborate with regulatory authorities and contribute to IND filings, clinical study reports, and other documentation required for regulatory approval.
- Support the creation and submission of non-clinical safety packages for regulatory bodies, ensuring compliance with global guidelines (FDA, EMA, ICH, etc.).
Scientific Leadership and Innovation:
- Stay at the forefront of scientific advancements in preclinical toxicology, particularly in the context of oncology therapeutics, and implement innovative strategies to improve the efficiency and accuracy of toxicology assessments.
- Provide mentorship and leadership to toxicology scientists, promoting scientific excellence, collaboration, and continuous learning within the organization.
Data Analysis and Reporting:
- Review and interpret toxicology study data and prepare high-quality reports for internal teams, management, and regulatory submissions.
- Ensure data is communicated effectively to inform development decisions and support company goals.
Budget and Resource Management:
- Develop and manage the budget for preclinical toxicology activities, ensuring that resources are used efficiently and projects are completed within budget and timeline constraints.
- Optimize resource allocation and ensure that toxicology studies are conducted on schedule and within financial parameters. .
Education & Experience
- Ph.D. in Toxicology, Pharmacology, or related field with significant experience in preclinical drug development, ideally in oncology or other therapeutic areas.
- A minimum of 6 years of experience in preclinical toxicology, with at least 3 years leading the toxicology strategy for a program in a biotech or pharmaceutical environment.
- DABT certification preferred.
- Extensive experience overseeing preclinical toxicology studies for biologics.
- Strong experience managing external CROs, contract laboratories, and vendors in the context of preclinical toxicology studies.
- Proven track record of success in IND filing and preclinical safety data packages for regulatory submissions.
Skills & Attributes
- Thrives in fast-moving, evolving environments, adapting quickly as data, priorities, and timelines shift.
- Translates complex data into clear, decision-ready recommendations for cross-functional teams and executives.
- Takes ownership for outcomes, driving programs forward and aligning internal teams and external partners.
- Practical, solutions-oriented individual who can balance scientific rigor with speed in a lean organization.
- Collaborative leader who builds trust and influence across functions and levels.
Korsana Biosciences is the sixth groundbreaking company launched by Paragon Therapeutics, a premier biotech incubator founded by Fairmount Funds in 2021, known for its expertise in discovering and developing cutting-edge therapeutic assets in-house.
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Korsana Biosciences is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status.
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