SCIENTIFIC DIRECTOR-8557140411
Description
Janssen Research and Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for a 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.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Scientific Director of Biologics Toxicology will provide strategic and scientific input on Biologics Toxicology Programs across the J&J organization. The Scientific Director of Biologics Toxicology will provide expert advice on nonclinical safety across the organization and on potential in licensing or out-licensing opportunities. The Scientific Director will represent Biologics Toxicology on Cross Functional Teams and be responsible for interfacing with worldwide regulatory agencies. This position is also responsible for interfacing with Contract Research Organizations in the design of protocol, conduct of studies, data interpretation, and preparation of final reports. The individual may also monitor studies as necessary.
This individual will represent Biologics Toxicology on multidisciplinary Project Teams; Develop strategy for development of Biopharmaceuticals; Interface with Contract Research Organizations in the development of study protocols, study conduct, data interpretation, and completion of final reports; Participate in the compilation of the non-clinical sections of regulatory filings; Educate Project Teams and other functional areas on toxicology requirements for drug development and the role of biologics toxicology in the development process; Continue education through participation in training courses and scientific meetings; Increase visibility for self and J&J through publications in peer review journal and presentations at major scientific/industry/regulatory meetings.
The 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. Provide an environment, which encourages the company's commitment to equal employment opportunity and the value of a diverse work force.
Qualifications
This position requires a Ph.D. in toxicology or related discipline (immunology, pharmacology, cell/tumor/molecular biology) with at least 12 years of pharmaceutical/biotechnology research management or related experience in drug development OR a MS in toxicology or related discipline (immunology, pharmacology, cell/tumor/molecular biology) with at least 15 years of pharmaceutical/biotechnology research management or related experience in drug development. Experience in design and execution of the nonclinical safety assessment strategy for biologics is required. Experience with the development of biologics therapeutics is required. This may include: monoclonal antibodies, alternative scaffolds, nucleic acid therapeutics and protein molecules. Cross-functional team interaction within a matrix environment is required. Interaction with Regulatory Agencies is required including experience in authoring toxicology sections of regulatory documents (e.g. IBs, INDs, EOP2, Scientific Advice, BLA). Experience interacting with CROs is preferred. Leadership experience is a plus. This role will require 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:LI NA
Primary Location:North America-United States-Pennsylvania-Spring House
Organization: Janssen Research & Development, LLC. (6084)
Job Function: Toxicology Research
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement