What are the responsibilities and job description for the Principal Toxicologist position at Initial Therapeutics, Inc.?
About the DepartmentDicerna, a Novo Nordisk company, is focused on driving innovation in RNAi (ribonucleic acid interference) to selectively target and silence genes that cause or contribute to disease. Our proprietary GalXC and GalXC-Plus RNAi technologies have the potential to address conditions that are difficult or impossible to treat with other modalities. Established as a Transformational Research Unit (TRU) following Novo Nordisk’s acquisition of Dicerna Pharmaceuticals, Inc. in December 2021, the Dicerna TRU is a unique new organization within Novo Nordisk that brings together the best of both worlds – the agility, collaborative pioneering spirit and calculated risk-taking profile of a biotech along with the scale, resources and capabilities of a global leader in drug development. With approximately 200 researchers, scientists, drug developers and operational staff, we are a team of inventive and entrepreneurial thinkers pushing the boundaries of science to create and drive new RNAi-based therapies for both rare and more prevalent diseases from the bench to the clinic. Together, we are driving change. Are you ready to make a difference?The PositionWe are seeking a Principal Toxicologist to help advance the development of our growing pipeline of product candidates. The individual in this position will be responsible for the design and oversight of toxicology studies conducted internally or externally, interpretation of toxicology data, and writing of regulatory submissions.RelationshipReports to : Executive Director, Toxicology, Program Development.Essential FunctionsIn conjunction with program teams, design and oversee conduct of external non-GLP investigative or GLP toxicology studies to support novel therapeutic agents through the drug development process.Review and provide feedback on related toxicology study protocols and reports.Contribute to the writing and preparation of nonclinical components for regulatory submissions.Collaborate on design of internal non-GLP investigative toxicity studies in support of development compounds as needed.Independently summarize and communicate toxicology data to program teams and executive leadership.Communicate toxicology timelines and budgets to stakeholders as needed.May monitor CRO toxicology studies.Independently manage complete toxicology programs (nonGLP and IND enabling).May participate in CRO evaluation or site visits.Collaborate cross-functionally with Research, Regulatory, Clinical, and Manufacturing and relevant program teams.Some travel may be required depending on project needs.Physical RequirementsApproximately 0-10% overnight travel. Ability to lift 0-10 lbs.QualificationsPh.D in a scientific discipline with 4 years or Master’s degree in a scientific discipline with 8 years of relevant pharmaceutical industry experience required. Degree in a toxicology-related discipline is preferred.Experience as a toxicologist supporting drug development programs required.Experience with oligonucleotides preferred.Knowledge of global regulatory guidances (e.g. ICH and geography-specific) and Good Laboratory Practice (GLP) standards required.Strong attention to detail, ability to critically evaluate all study documentation (eg. protocols, data, reports) required.Ability to critically evaluate written toxicology documents for overall quality and acceptability of scientific interpretation required.Effective organization skills and ability to work in a multi-tasking, fast-paced environment required.Experience in developing toxicology programs to support early and later stage drug development and in preparing regulatory filings such as INDs / CTAs. Experience in conducting GLP repeat-dose, reproductive, and genetic toxicology studies is preferred.Goal oriented, highly self-motivated and self-directing individual who enjoys working in different environments and multiple capacities preferred.Ability to work well in a team setting / matrix-type organization and to build strong cross-functional relationships preferred.Enthusiasm for meeting program timelines and goals preferred.We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.#J-18808-Ljbffr
