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Associate Scientific Director, Immunological Toxicology

The Associate Scientific Director, Immunological Toxicology will evaluate potential immune system-related effects associated with large and small molecule therapeutics in our pipeline.  The Associate Scientific Director will work with Project Toxicologists and nonclinical safety team to provide strategic and scientific input - to progress therapeutics from discovery to first-in-human and through development. As an Associate Scientific Director additional responsibility will include: Provides immunological expertise to nonclinical safety teams, designs strategies to evaluate potential immunotoxicology risks, and participates in assessments. Strategies will include literature evaluation, as well as, direct experimental approaches performed in-house and at Contract Research Organizations (CROs).  Interacts with CROs at multiple levels, including: transferring methods developed at Janssen, monitoring CRO validations, and the monitoring of immune endpoints during both GLP and non-GLP studies. Independently designs, conducts and leads studies to evaluate the effects of immunomodulatory compounds using various in vivo and in vitro model systems including, but not limited to, cytokine assessment, immune response, flow cytometry and functional cell-based assays following Data Integrity standards, and writes reports for regulatory submission.    Investigates and develops novel experimental methods/technologies, contributes to improvement of existing methods and develops new in vitro/in vivo models to enhance our understanding of potential immunotoxicology risk and translatability to humans in the clinic. Participates in communication of information and data presentation in oral and written format both in-house and at appropriate external forums. Maintains an industry leading expertise in Immunotoxicology. Represents the organization to senior management and peer groups within Janssen and Johnson & Johnson. Maintains strong scientific network in academia and the pharmaceutical/biotechnology industry to enable external interactions, consulting and recruiting. Be a mentor/coach to key scientific staff and guide/enable their career/professional development. Responsible for the development of all employees within the department by supporting the development of Human Resources Planning (HRP) programs including management development and training to meet current and future business needs.  Provide an environment, which encourages the company's commitment to equal employment opportunity and the value of a diverse work force. Qualifications PhD in immunology, immunotoxicology, toxicology or related discipline with 3 years of relevant experience OR M.S. degree in immunology, immunotoxicology, toxicology or related discipline with 7 years of relevant experience OR a professional degree (DVM, VMD) with 3 years of relevant experience is required Established expertise in Immunotoxicology is required Expertise in immunological techniques (e.g. flow cytometry, immunoassays) is required Deep scientific expertise in immunology is preferred Experience in pharmaceutical/biotechnology research management or related experience in drug development is required  Knowledge of GLPs is required Knowledge of Health Authority regulations and guidelines for drug development (e.g. ICH, FDA, EMEA, PMDA) is preferred Previous experience managing external partnerships (CRO's) is required Strong leadership skills with highly collaborative instincts This role requires excellent communication and interpersonal skills, a high level of organizational ability and attention to detail. 3859180612
Salary Range: NA
Minimum Qualification
Less than 5 years

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