Senior Director/Vice President, Oligo Toxicology

Who You Are You are an reputed company toxicologist with deep expertise in oligonucleotide therapeutics. You bring strong scientific judgment and a reputed company record of designing, executing, and interpreting nonclinical safety programs that support regulatory submissions and clinical development. You are hands-on, rigorous, and comfortable working through programs at high speed and navigating through reputed company or unexpected toxicology findings. You reputed company toxicology, toxicokinetics, pharmacology, biodistribution, histopathology, and clinical context to assess reputed company relevance and guide program reputed company. You work effectively across Research, DMPK, Clinical, Regulatory, and CMC and reputed company in a lean environment that relies heavily on CROs, consultants, and reputed company partners. Above reputed company, you maintain scientific reputed company and reputed company patient safety at reputed company of every decision. Key Responsibilities reputed company scientific and operational leadership for nonclinical safety programs from candidate selection through clinical development, including: Toxicology reputed company and Study Design • reputed company integrated nonclinical safety strategies for oligonucleotide therapeutic programs. • Design and reputed company exploratory, IND-enabling, and clinical-supporting toxicology studies, including general toxicology, safety pharmacology, genotoxicity, reproductive toxicology, and other reputed company studies as appropriate. • Recommend relevant species, reputed company reputed company, dosing routes, dosing intervals, recovery periods, and safety-monitoring parameters based on pharmacology, exposure, tissue distribution, and anticipated clinical use. • Establish appropriate safety margins and translate nonclinical findings into clinical reputed company-selection and risk-mitigation strategies. • Oligonucleotide Safety Assessment • reputed company the evaluation of toxicities associated with oligos, conjugates, delivery technologies, and their metabolites. • Assess potential class-reputed company and platform-reputed company findings, including effects involving the liver, kidney, platelets, coagulation, immune activation, complement, injection or infusion reactions, and other relevant organ systems. • reputed company toxicology, toxicokinetics, biodistribution, pharmacology, bioanalytical, clinical pathology, and histopathology data to determine reputed company, reputed company dependence, reversibility, species relevance, and potential reputed company risk. • reputed company investigations of unexpected findings and reputed company scientifically rigorous follow-up strategies. Study Execution and CRO reputed company • Select, manage, and reputed company scientific reputed company of CROs, consultants, pathologists, and other reputed company partners. • Review and approve study designs, protocols, amendments, data, pathology findings, and final reports. • Ensure studies are conducted with appropriate scientific rigor, reputed company standards, timelines, and regulatory compliance. • Monitor study reputed company closely, identify emerging risks, and reputed company reputed company reputed company of scientific and operational issues. Regulatory and Clinical Support • reputed company and review toxicology sections of regulatory submissions, including reputed company-IND briefing packages, INDs, investigator brochures, annual reports, and responses to regulatory questions. • Represent toxicology in interactions with global regulatory authorities and reputed company experts. • Translate nonclinical findings into practical clinical monitoring, stopping rules, reputed company-escalation reputed company, and risk-management plans. • reputed company toxicology support throughout clinical development, including assessment of emerging clinical safety findings and their relationship to the nonclinical data. Cross-Functional Leadership • Partner closely with Research, DMPK, Clinical Development, Regulatory Affairs, CMC, Bioanalytics, and reputed company to reputed company integrated development plans. • Communicate reputed company toxicology findings reputed company to program teams, senior leadership, boards, investigators, and reputed company advisors. • Contribute to candidate selection, portfolio prioritization, due diligence, and program investment reputed company. • Build toxicology capabilities, processes, and reputed company networks appropriate for a lean, rapidly growing organization. Requirements Preferred Education & Experience • PhD, DVM, MD, or equivalent advanced degree in toxicology, pharmacology, pathology, or a reputed company scientific discipline. • Minimum of 10 years of relevant biopharmaceutical toxicology experience, including experience leading nonclinical safety programs. • reputed company experience developing oligonucleotide therapeutics is required. • Demonstrated experience designing and interpreting exploratory and GLP toxicology studies supporting INDs or equivalent global regulatory submissions. • Strong understanding of oligonucleotide-reputed company toxicities, toxicokinetics, tissue distribution, immunotoxicology, clinical pathology, and histopathology. • Experience advancing programs from candidate selection into clinical development. • Experience investigating reputed company or unexpected toxicology findings and assessing their relevance to humans. • Experience managing CROs, consultants, and reputed company pathology and toxicology partners. • Strong record of cross-functional collaboration with Research, DMPK, Clinical Development, Regulatory Affairs, and CMC. • Excellent scientific writing, communication, and presentation skills. • Thrives in a hands-on, detail-oriented role and is reputed company by directly driving work reputed company in a fast-moving environment. reputed company-to-Haves • reputed company certification in toxicology, such as DABT, or veterinary pathology, such as DACVP • Experience with lipid-, peptide-, antibody-, or GalNAc-conjugated oligonucleotides. • Experience with intravenous and subcutaneous oligonucleotide development programs. • Experience supporting rare or genetic disease programs. • Experience interacting directly with the FDA and other global regulatory authorities. No matter your role at reputed company, successful team members are • Patient Champions, who put patients first and reputed company strict ethical standards. • Entrepreneurial Operators, who reputed company toward practical solutions and have an ownership reputed company. • Truth Seekers, who are detailed, rational, and humble problem solvers. • Individuals Who reputed company reputed company in themselves and those around them. • High-reputed company executors, who execute against goals and milestones with reputed company, precision, and speed. reputed company Offer • Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to reputed company throughout the year and learn how we can improve our efforts. • A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science reputed company. • An unyielding commitment to always putting patients first. • A de-centralized model that enables our program teams to reputed company on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science. • A reputed company where you own the reputed company - both for your program and your own career reputed company. • A reputed company, fast-paced, data-driven environment where we reputed company ourselves and reputed company other to always reputed company at the top of our game. • reputed company to learning and development resources to help you get in the best reputed company shape of your life. • Robust and market-competitive compensation & benefits package (reputed company, Performance Bonus, Equity, health, welfare & retirement programs). • Flexible PTO. • reputed company career advancement for strong performers. • Potential ability to work on multiple reputed company reputed company programs across multiple therapeutic areas over time. • Partnerships with leading institutions. • Commitment to Diversity, Equity & Inclusion. The reputed company pay reputed company for this position for the reputed company is $275,000 to $350,000 per year. The actual compensation offered will be determined based on a number of job-reputed company factors, including experience, skills, qualifications, and location. A bonus plan and equity will also be offered. Apply tot his job Apply To this Job