BioSpace, Inc.
Director, Toxicology, Non-clinical Development
BioSpace, Inc., San Diego, California, United States, 92189
Overview
Director, Toxicology, Non-clinical Development Avidity Biosciences, San Diego, CA (Onsite) At Avidity Biosciences, we are passionate about the impact of every employee in realizing our vision of improving peoples lives by delivering a new class of RNA therapeutics. Avidity is developing Antibody Oligonucleotide Conjugates (AOCs) and leading clinical programs in several rare muscle diseases. This role leads a team of toxicologists across research and development and provides in-house subject matter expertise in regulatory toxicology strategy, dossier writing, and health authority interactions. The Director will manage a team of toxicologists, mentor staff, and collaborate with cross-functional partners to define and implement non-clinical development strategies from discovery to late-stage development. The Opportunity
Avidity is seeking an experienced non-clinical development scientist to lead a team of toxicologists and work in a matrixed environment to define and execute non-clinical development plans for programs from discovery to late-stage development. The Director will interact with senior leadership and contribute to regulatory strategy and health authority engagements. What You Will Contribute
Serve as a key member of multidisciplinary R&D teams to define and implement non-clinical safety evaluation strategy for novel candidate molecules. Lead evaluation of potential safety and toxicity liabilities of biologic pathways from early development through filing (Repro, Carcinogenicity, etc.). Lead design and conduct of experiments to inform translatability of non-clinical safety findings to humans. Manage non-clinical development studies in-house and at contract research organizations. Partner cross-functionally with Biology, Biomarkers, and PKPD to design and interpret non-clinical pharmacology and human dose projection studies. Draft and review non-clinical sections of regulatory documents (IND, IMPD, CTA & IB) including pharmacology, pharmacokinetics, and toxicology. Participate in and lead non-clinical strategy discussions with health authorities (FDA, EMA, PMDA, etc.) from pre-IND through pre-BLA. Represent Avidity with external vendors to manage budgets, timelines, monitoring, protocol design, reporting, and compliance. Mentor toxicology staff and provide scientific guidance within a matrix-management framework. Manage a team of toxicologists and contribute to program decisions as a toxicology SME.
What We Seek
Minimum of 10+ years of relevant experience in toxicology, pathology, pharmacology, or related discipline, with PhD or MS; post-doctoral experience preferred. MS candidates typically bring 15+ years of experience. Excellent interpersonal skills and ability to work in a matrix environment with key stakeholders. Strong communication and presentation skills for project teams and senior leadership. Experience with large molecules (monoclonal antibody) and/or oligonucleotide modalities in drug discovery/development is desirable. Experience representing a company on outsourced toxicology studies, including CRO selection, contracting, budgeting, timelines, protocol design, and regulatory compliance. Experience in a regulated environment with knowledge of GLP, FDA/EMA/ICH guidelines. Experience with late-stage development regulatory toxicology strategy. Proven ability to work independently, multi-task, and influence scientific strategy across the organization.
What We Will Provide You
The base salary range for this role is $228,000 - $252,000. Final compensation will reflect relevant experience, skillset, internal equity, and market factors. Competitive compensation and benefits, including annual and spot bonuses, stock options/RSUs, and a 401(k) with employer match. Wellness program with medical, dental, vision, LTD coverage and four weeks of vacation. Commitment to learning and development, including internal programming and education reimbursement.
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Director, Toxicology, Non-clinical Development Avidity Biosciences, San Diego, CA (Onsite) At Avidity Biosciences, we are passionate about the impact of every employee in realizing our vision of improving peoples lives by delivering a new class of RNA therapeutics. Avidity is developing Antibody Oligonucleotide Conjugates (AOCs) and leading clinical programs in several rare muscle diseases. This role leads a team of toxicologists across research and development and provides in-house subject matter expertise in regulatory toxicology strategy, dossier writing, and health authority interactions. The Director will manage a team of toxicologists, mentor staff, and collaborate with cross-functional partners to define and implement non-clinical development strategies from discovery to late-stage development. The Opportunity
Avidity is seeking an experienced non-clinical development scientist to lead a team of toxicologists and work in a matrixed environment to define and execute non-clinical development plans for programs from discovery to late-stage development. The Director will interact with senior leadership and contribute to regulatory strategy and health authority engagements. What You Will Contribute
Serve as a key member of multidisciplinary R&D teams to define and implement non-clinical safety evaluation strategy for novel candidate molecules. Lead evaluation of potential safety and toxicity liabilities of biologic pathways from early development through filing (Repro, Carcinogenicity, etc.). Lead design and conduct of experiments to inform translatability of non-clinical safety findings to humans. Manage non-clinical development studies in-house and at contract research organizations. Partner cross-functionally with Biology, Biomarkers, and PKPD to design and interpret non-clinical pharmacology and human dose projection studies. Draft and review non-clinical sections of regulatory documents (IND, IMPD, CTA & IB) including pharmacology, pharmacokinetics, and toxicology. Participate in and lead non-clinical strategy discussions with health authorities (FDA, EMA, PMDA, etc.) from pre-IND through pre-BLA. Represent Avidity with external vendors to manage budgets, timelines, monitoring, protocol design, reporting, and compliance. Mentor toxicology staff and provide scientific guidance within a matrix-management framework. Manage a team of toxicologists and contribute to program decisions as a toxicology SME.
What We Seek
Minimum of 10+ years of relevant experience in toxicology, pathology, pharmacology, or related discipline, with PhD or MS; post-doctoral experience preferred. MS candidates typically bring 15+ years of experience. Excellent interpersonal skills and ability to work in a matrix environment with key stakeholders. Strong communication and presentation skills for project teams and senior leadership. Experience with large molecules (monoclonal antibody) and/or oligonucleotide modalities in drug discovery/development is desirable. Experience representing a company on outsourced toxicology studies, including CRO selection, contracting, budgeting, timelines, protocol design, and regulatory compliance. Experience in a regulated environment with knowledge of GLP, FDA/EMA/ICH guidelines. Experience with late-stage development regulatory toxicology strategy. Proven ability to work independently, multi-task, and influence scientific strategy across the organization.
What We Will Provide You
The base salary range for this role is $228,000 - $252,000. Final compensation will reflect relevant experience, skillset, internal equity, and market factors. Competitive compensation and benefits, including annual and spot bonuses, stock options/RSUs, and a 401(k) with employer match. Wellness program with medical, dental, vision, LTD coverage and four weeks of vacation. Commitment to learning and development, including internal programming and education reimbursement.
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