Associate Scientific Director, Toxicology
Scorpion Therapeutics, Rancho Santa Fe, California, United States
Role Summary
As a scientific leader, develop and lead Toxicology/Safety Pharmacology projects, oversee studies from planning through to final reporting. Participate in formulating the strategic and operational direction of the function ensuring all studies are conducted in line and adhere to appropriate guidelines and regulatory testing standards and individual program objectives. Recommend scientific strategies for overall programs and/or department. Represent Toxicology on Development teams and may advise senior technical leadership of Toxicology/Safety pharmacology findings and recommendations. Responsibilities
Lead toxicology strategy and execution for new and existing drug candidates Design, evaluate, and manage Toxicology and Safety Pharmacology studies, including protocol development, budgeting, oversight, and reporting Analyze and interpret study data; prepare technical reports and oral presentations for internal key stakeholders Own preparation and quality control of regulatory documents (IB, IND, CTA, NDA/BLA), including annual updates and submissions Recommend and implement process improvements and SOP updates to optimize program efficiency Stay current with global regulatory guidance and proactively inform stakeholders Collaborate across multidisciplinary teams and support technical documentation and database management Mentor junior scientists, and lead/contribute to intellectual property development Lead the development of intellectual property Support additional strategic initiatives as needed Qualifications
Required: BS/BA in Toxicology, Pharmacology, Biology, or related discipline with 15+ years of CRO and/or pharmaceutical industry experience, including Safety Pharmacology Required: MS/MA with 13+ years Required: PhD with 7+ years in similar fields and roles Required: Extensive experience in Safety Pharmacology, Toxicology, and Pathology across small molecules, peptides, and biologics (gene therapy knowledge a plus) Required: Proven leadership in managing preclinical CROs and regulatory submissions (IB, IND, CTA, NDA/BLA/MAA) Required: Strong knowledge of ICH and FDA guidance Preferred: DABT certification Skills
Strong knowledge of ICH and FDA guidance
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As a scientific leader, develop and lead Toxicology/Safety Pharmacology projects, oversee studies from planning through to final reporting. Participate in formulating the strategic and operational direction of the function ensuring all studies are conducted in line and adhere to appropriate guidelines and regulatory testing standards and individual program objectives. Recommend scientific strategies for overall programs and/or department. Represent Toxicology on Development teams and may advise senior technical leadership of Toxicology/Safety pharmacology findings and recommendations. Responsibilities
Lead toxicology strategy and execution for new and existing drug candidates Design, evaluate, and manage Toxicology and Safety Pharmacology studies, including protocol development, budgeting, oversight, and reporting Analyze and interpret study data; prepare technical reports and oral presentations for internal key stakeholders Own preparation and quality control of regulatory documents (IB, IND, CTA, NDA/BLA), including annual updates and submissions Recommend and implement process improvements and SOP updates to optimize program efficiency Stay current with global regulatory guidance and proactively inform stakeholders Collaborate across multidisciplinary teams and support technical documentation and database management Mentor junior scientists, and lead/contribute to intellectual property development Lead the development of intellectual property Support additional strategic initiatives as needed Qualifications
Required: BS/BA in Toxicology, Pharmacology, Biology, or related discipline with 15+ years of CRO and/or pharmaceutical industry experience, including Safety Pharmacology Required: MS/MA with 13+ years Required: PhD with 7+ years in similar fields and roles Required: Extensive experience in Safety Pharmacology, Toxicology, and Pathology across small molecules, peptides, and biologics (gene therapy knowledge a plus) Required: Proven leadership in managing preclinical CROs and regulatory submissions (IB, IND, CTA, NDA/BLA/MAA) Required: Strong knowledge of ICH and FDA guidance Preferred: DABT certification Skills
Strong knowledge of ICH and FDA guidance
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