Associate Scientific Director - Biologics Toxicology-1372141209
Description
Janssen Research and Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Scientific Director, Biologics Toxicology, located in Spring House, PA.
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer’s disease, epilepsy, migraine prevention and treatment), pain management, and women’s health. Our ultimate goal is to help people live healthy lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market – from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visit www.janssenpharmaceuticalsinc.com
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Associate Scientific Director of Biologics Toxicology will be a part of the Biotechnology Center of Excellence and have the opportunity to participate in the development of cutting edge biotherapeutics. These may include novel, first-in-class technologies including stem cell therapies, monoclonal antibodies, alternative scaffolds, nucleic acid therapeutics, and protein molecules.
The Associate Scientific Director of Biologics Toxicology will provide strategic and scientific input on nonclinical Biologics Toxicology Programs across the J&J organization and expert advice on nonclinical safety of potential in licensing or out-licensing opportunities. This individual will represent Biologics Toxicology on Cross Functional Teams, develop and execute nonclinical toxicology strategies, and interface with Contract Research Organizations (CROs) in the design of protocols, conduct of studies, data interpretation, and preparation of final reports. The individual may also monitor studies as necessary. The Associate Scientific Director of Biologics Toxicology will participate in the compilation of the nonclinical sections of regulatory filings and be responsible for interfacing with worldwide regulatory agencies.
The Associate Scientific Director of Biologics Toxicology will have a desire for learning and innovation, and continue career development through participation in training courses and scientific meetings, and increase visibility for self and J&J through publications in peer review journal and presentations at major scientific/industry/regulatory meetings.
The Associate Scientific Director will also be 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 and provide an environment, which encourages the company's commitment to equal employment opportunity and the value of a diverse work force.
Qualifications
Ph.D. in toxicology or related discipline (immunology, pharmacology, cell/tumor/molecular biology) with at least 6 years of pharmaceutical/biotechnology research management or related experience in drug development is required
DABT certification is preferred
Knowledge of GLPs and Health Authority regulations and guidelines for the development of biologics (e.g. ICH, FDA, EMEA, PMDA) is required
Experience in the design and execution of the nonclinical safety assessment strategy for biologic therapeutics is required
Previous pharmaceutical/biotech industry experience is required
Cross-functional team interaction within a matrix environment, working with CROs, and interacting with Regulatory Agencies including experience in authoring toxicology sections of regulatory documents (e.g. IBs, INDs, EOP2, Scientific Advice, BLA) is required
Previous leadership experience is preferred
This role requires excellent communication and interpersonal skills, a high level of organizational ability and attention to detail
Some travel (domestic and international) is required dependent on project needs
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:BIO
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Primary Location:North America-United States-Pennsylvania-Spring House
Organization: Janssen Research & Development, LLC. (6084)
Job Function: R&D
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