Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies is recruiting for an Associate Director, located in Spring House, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/ for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
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 Janssen BioTherapeutics and will support the development of novel biotherapeutic therapies which may include first-in-class technologies, stem cell therapies, monoclonal and bispecific antibodies, alternative scaffolds, nucleic acid therapeutics, and protein molecules. 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, JBIO and J&J through publications, participation in external organizations, and presentations at major scientific, industry, and regulatory meetings.
Responsibilities include but are not limited to:
Providing strategic and scientific input to multidisciplinary Project Teams progressing biotherapeutics through the development process from discovery to marketing and life cycle management
Identify and analyze high-impact, complex, and cross-department scientific and technical issues and gaps
Lead cross-functional subteams
Interface with worldwide regulatory agencies and prepare nonclinical sections of regulatory filings
Collaborate with Contract Research Organizations in the design of protocols, conduct of studies, data interpretation, and preparation of final reports
Contribute to scientific and technical decisions on the acquisition of new products and projects
Have a desire for learning and innovation, and continue career development through participation in training courses and scientific meetings, and increase visibility for self, JBIO and J&J through publications, participation in external organizations, and presentations at major scientific, industry, and regulatory meetings
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
• Ph.D. in toxicology or related discipline (immunology, pharmacology, cell/tumor/molecular biology, or related field) 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
• Prior experience serving as a Study Director and/or Study Monitor for nonclinical safety studies of biopharmaceuticals is preferred
• Experience 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 (coaching, mentoring, leading projects and subteams) is preferred
• Some travel (domestic and international) is required dependent on project needs
United States-Pennsylvania-Spring House
Janssen Research & Development, LLC. (6084)
A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.