Executive Director, Toxicology

JOB PURPOSE

We are seeking an experienced development Toxicologist to join our Pharmacology/Toxicology group. The qualified candidate is a highly motivated, interactive, and creative individual that has demonstrated expertise in drug development to work across a highly matrixed environment to advance translational efforts. This role is integral to driving discovery research into the clinic, including exploratory, pilot, and pivotal toxicology studies and health authority interactions. This person is responsible for the overall strategy and conduct of the studies supporting a Project Team and is thus an expert on study process and specialist needs for cell and gene therapy products. The candidate will be expected to work collaboratively within Development Sciences and to liaise closely with the Project teams to develop Toxicology strategies for advancement to the clinic. The role reports to the VP of Toxicology/Pathology/Biodistribution and brings strategic input to Senior Management to align and advance corporate goals and milestones.

DUTIES AND RESPONSIBILITIES

• Sit as representative for Toxicology on Project and Core Teams and guide, develop, and drive the Toxicology strategy for the team
• Work collaboratively with Research, Pharmacology, Pathology, CMC, and Bioanalytical scientists to progress therapeutics through the pipeline from discovery to launch
• Provide internal expertise to understand the mechanisms of toxicity observed non-clinically and/or clinically in order to drive mitigation and/or back-up strategies to minimize potential harm to patients
• Responsible for building and maintaining effective CRO relationships that support the execution of non-GLP and GLP toxicology/biodistribution studies
• Review study protocols and draft PI and study reports, provide feedback to Study Director or PI's as needed and responsible for report finalization
• Liaise with Associate Director of Non-clinical Operations for oversight and monitoring of studies at CRO's
• Present data and interpretations in written and oral form
• Write regulatory summaries for safety pharmacology, biodistribution, and toxicology data sets for submissions in the US and ex-US (eg. IND, CTA, BLA, briefing books, Investigator Brochures etc)
• Working knowledge of code of federal regulations (eg. CFR 21 Part 11 and Part 58 etc) and regulatory guidance's (eg. FDA, EMA, ICH etc) as it pertains to the strategic planning and conduct of safety packages to support first-in-human (FIH) testing
• Build collaborative networks both internal and external to the company to ensure rapid communication and cross-functional evaluations and investigation
• Represent SANA Bio in the external scientific environment

QUALIFICATIONS

Basic Qualifications

• Bachelors in a scientific discipline with a PhD or DVM and 10+ years of experience in a pharmaceutical/biotech setting
• Prior role in multidisciplinary projects and teams with ability to integrate cross-functional information, desired
• Demonstrated ability in developing and implementing toxicology strategies for teams including species selection, biodistribution, target organ identification, and selection and justification of maximum tolerated dose or NOAEL
• Strong scientific writing skills to prepare and review non-clinical sections (eCTD Modules 2.4 and 2.6) for IND or CTA submission, preparation of briefing books (Interact or Pre-IND), Investigator Brochures, BLA etc
• Strong collaboration and relationship building and decision-making skills
• Demonstrated subject matter expert in regulatory toxicology
• Working knowledge of regulatory needs for conduct of both non-GLP and GLP studies
• Experience with outsourcing and conducting safety studies at CROs
• Familiarity with regulatory requirements for cell or gene therapies or similar novel biotherapeutics
• Familiarity with presenting strategy to teams or management, aligning and achieving buy-in for strategic approach including risk-based approach

Preferred Qualifications

• Ph.D. in toxicology, pathology, comparative biology, molecular pathology, immunology, virology, or a related field, DABT or equivalent
• Experience with managing CRO relationships and collaborating with KOL's would be advantageous
• Familiarity with developing Toxicology strategies for cell and gene therapies and CART therapies
• Experience advancing cell and or viral vector-based gene therapies a plus
• Demonstrated skills in critical thinking, problem solving, and mechanistic investigation evidenced by scientific publications or presentations a plus