BioSpace
Director, Toxicology, Non-clinical Development
BioSpace, San Diego, California, United States, 92189
Director, Toxicology, Non-clinical Development
Profoundly Improve People’s lives by Revolutionizing the Delivery of RNA Therapeutics At Avidity Biosciences, we are passionate about the impact of every employee in realizing our vision of improving people’s lives by delivering a new class of RNA therapeutics. Avidity is revolutionizing the field of RNA with its proprietary AOCs, which are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to address targets and diseases previously unreachable with existing RNA therapies. Avidity Biosciences, Inc.'s mission is to profoundly improve people's lives by delivering a new class of RNA therapeutics - Antibody Oligonucleotide Conjugates (AOCs). Utilizing its proprietary AOC platform, Avidity demonstrated the first-ever successful targeted delivery of RNA into muscle and is leading the field with clinical development programs for three rare muscle diseases: myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). The Opportunity
Avidity is seeking an experienced Non-clinical Development Scientist to lead a team of toxicologists that spans research and development. In this role, the successful candidate will work cross-functionally in a matrixed environment to define and implement non-clinical development strategies and successfully execute plans for programs from discovery to late-stage development. The Director will bring early and late-stage drug development experience across multiple therapeutic areas and will be relied upon as an in-house subject matter expert (SME) in regulatory toxicology strategy, dossier writing, and health authority interactions. Responsibilities
Serve as a key member of multidisciplinary research and development teams representing the toxicology function to define and implement non-clinical safety evaluation strategy for novel candidate molecules. Lead the evaluation of potential safety and toxicity liabilities of biologic pathways of interest from early development (screening toxicity) through filing (Repro, Carcinogenicity, etc.). Lead the design and conduct of experiments to inform the potential translatability and relevance of non-clinical safety findings to humans. Manage non-clinical development studies in-house and at contract research organizations. Closely partner and interact cross-functionally with Avidity’s Biology, Biomarkers, and PKPD leaders in the design and interpretation of non-clinical pharmacology and efficacy studies related to the assessment of PKPD and human dose projection. Draft and review non-clinical sections of regulatory documents (IND, IMPD, CTA & IB briefing packages) including non-clinical pharmacology, pharmacokinetics, and toxicology. Participate in and lead non-clinical strategy discussions in meetings with various 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 and have matrix management responsibilities for other toxicology program representatives by providing scientific guidance and by leading by example. Manage a team of toxicologists. Requirements
Minimum of 10+ years of relevant experience in toxicology, pathology, pharmacology, or a related discipline, with either a PhD or MS; post-doctoral experience preferred. Excellent interpersonal skills, ability to work in a matrix environment and develop relationships with key stakeholders Excellent communication and presentation skills to efficiently inform project teams, senior management team and other key stakeholders Experience with large molecules (monoclonal antibody) and/or oligonucleotide based therapeutic modalities in drug discovery and development desired Experience as a company representative on outsourced toxicology studies managing CRO selection, contracting, budgeting, evaluation, timelines, communication, monitoring, protocol design, study execution, reporting, and regulatory compliance Experience working in a regulated environment and knowledge of GLP regulations and relevant FDA, EMA, and ICH guidelines Experience with late-stage development regulatory tox strategy Proven ability to work independently and be self-motivated What We Offer
The base salary range for this role is $228,000 - $252,000. Avidity offers competitive compensation and benefits, including the opportunity for annual and spot bonuses, stock options, RSUs, and a 401(k) with an employer match. A commitment to learning and development, including a variety of internal programming developed by and for Avidity employees, opportunities for job-specific training offered by industry, and an education reimbursement program.
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Profoundly Improve People’s lives by Revolutionizing the Delivery of RNA Therapeutics At Avidity Biosciences, we are passionate about the impact of every employee in realizing our vision of improving people’s lives by delivering a new class of RNA therapeutics. Avidity is revolutionizing the field of RNA with its proprietary AOCs, which are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to address targets and diseases previously unreachable with existing RNA therapies. Avidity Biosciences, Inc.'s mission is to profoundly improve people's lives by delivering a new class of RNA therapeutics - Antibody Oligonucleotide Conjugates (AOCs). Utilizing its proprietary AOC platform, Avidity demonstrated the first-ever successful targeted delivery of RNA into muscle and is leading the field with clinical development programs for three rare muscle diseases: myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). The Opportunity
Avidity is seeking an experienced Non-clinical Development Scientist to lead a team of toxicologists that spans research and development. In this role, the successful candidate will work cross-functionally in a matrixed environment to define and implement non-clinical development strategies and successfully execute plans for programs from discovery to late-stage development. The Director will bring early and late-stage drug development experience across multiple therapeutic areas and will be relied upon as an in-house subject matter expert (SME) in regulatory toxicology strategy, dossier writing, and health authority interactions. Responsibilities
Serve as a key member of multidisciplinary research and development teams representing the toxicology function to define and implement non-clinical safety evaluation strategy for novel candidate molecules. Lead the evaluation of potential safety and toxicity liabilities of biologic pathways of interest from early development (screening toxicity) through filing (Repro, Carcinogenicity, etc.). Lead the design and conduct of experiments to inform the potential translatability and relevance of non-clinical safety findings to humans. Manage non-clinical development studies in-house and at contract research organizations. Closely partner and interact cross-functionally with Avidity’s Biology, Biomarkers, and PKPD leaders in the design and interpretation of non-clinical pharmacology and efficacy studies related to the assessment of PKPD and human dose projection. Draft and review non-clinical sections of regulatory documents (IND, IMPD, CTA & IB briefing packages) including non-clinical pharmacology, pharmacokinetics, and toxicology. Participate in and lead non-clinical strategy discussions in meetings with various 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 and have matrix management responsibilities for other toxicology program representatives by providing scientific guidance and by leading by example. Manage a team of toxicologists. Requirements
Minimum of 10+ years of relevant experience in toxicology, pathology, pharmacology, or a related discipline, with either a PhD or MS; post-doctoral experience preferred. Excellent interpersonal skills, ability to work in a matrix environment and develop relationships with key stakeholders Excellent communication and presentation skills to efficiently inform project teams, senior management team and other key stakeholders Experience with large molecules (monoclonal antibody) and/or oligonucleotide based therapeutic modalities in drug discovery and development desired Experience as a company representative on outsourced toxicology studies managing CRO selection, contracting, budgeting, evaluation, timelines, communication, monitoring, protocol design, study execution, reporting, and regulatory compliance Experience working in a regulated environment and knowledge of GLP regulations and relevant FDA, EMA, and ICH guidelines Experience with late-stage development regulatory tox strategy Proven ability to work independently and be self-motivated What We Offer
The base salary range for this role is $228,000 - $252,000. Avidity offers competitive compensation and benefits, including the opportunity for annual and spot bonuses, stock options, RSUs, and a 401(k) with an employer match. A commitment to learning and development, including a variety of internal programming developed by and for Avidity employees, opportunities for job-specific training offered by industry, and an education reimbursement program.
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