Description Johnson & Johnson, through its 250 operating companies, is the world's most comprehensive and broadly based manufacturer of health care products with over 120,000 employees worldwide. Advanced Technologies and Regenerative Medicine LLC, (ATRM) is a results-driven R&D organization dedicated to delivering innovative products through convergence of core capabilities, applied research and technology solutions in the areas of cells, biomaterials, nanotechnologies, localized drug delivery systems and bioactives. Our research and technology platforms are applied toward generating new product concepts through collaborations with our R&D and commercial colleagues across Johnson & Johnson. Advanced Technologies and Regenerative Medicine LLC, (ATRM), is recruiting for a Principal Scientist, PK/PD, located in Somerville, NJ.
The PK/PD Principal Scientist will be providing preclinical and clinical support for a portfolio of large and small molecules as well as cell therapy. The Principal Scientist will be responsible for design, conduct and interpretation of pharmacokinetic studies supporting discovery and early development projects and the application of pharmacokinetic and pharmacodynamic (PK/PD) principles to aid in the interpretation of in vivo pharmacology data for the selection and advancement of drug and cell therapy discovery projects. The candidate will implement modeling and simulation research initiatives to support preclinical and clinical studies to enable the ultimate development of innovative technologies and products including implantable devices, drug enhanced devices, bioactives and regenerative medicine products. This position represents PK/PD on multidisciplinary project teams.
The PK/PD Principal Scientist will assist in preparation of the preclinical and clinical pharmacology development plans; support projects in the ATRM portfolio. Responsible for the preparation of PK analysis plan, data analysis, and preparation of PK/PD study reports; assist in the preparation of briefing documents, INDs, representing preclinical and clinical pharmacology to regulatory agencies; collaborate with functional groups and project management in the delivery of specific functional milestones to meet ATRM goals and timelines. Specifically, the PK/PD Principal Scientist will provide hands on leadership and support for the design and execution of PK/PD studies for a number of large and small molecule programs in various stages of development.; participate in bioanalytical, including immunological methods for marker development and validation; perform preclinical and clinical PK/PD data analysis using a variety of programs, i.e. WinNonlin, NONMEM, and SAS and using external resources as necessary; develop and apply PK/PD modeling strategies, including identification of necessary internal and external resources including consultants, computer programs and software; write preclinical and clinical study reports; interface with cell biology, formulation, drug delivery, toxicology, regulatory and clinical research; support the preparation of PK/PD briefing documents, INDs with minimal supervision from department management.
Represent Preclinical and Clinical pharmacology in meetings with FDA and other regulatory agencies as needed; participate in project reviews, create and deliver clear presentations regarding PK/PD to senior management; network outside J&J to establish a resource for the identification and selection of external PK/PD experts; understand APUS SOPs, regulations/guidelines for drug development (FDA, ICH, cGCP) and ensure that they are followed. QualificationsA minimum of a PhD or Pharm D in Pharmacy, Pharmaceutical Sciences or a related field, and at least 7 years experience with PK/PD modeling of large and small molecules in the healthcare industry is required. Previous experience must include hands-on experience with PK/PD modeling and development of mathematical PK/PD models. Experience in application of software such as WinNonlin, NONMEM, and S-Plus is required.
Experience in the design and execution of PK/PD studies and development of mathematical PK/PD is required. PK/PD expertise in a dynamic discovery and product development environment and experience with PK/PD, biomarker and immunological tests of various therapeutic areas, pharmacokinetics and pharmacodynamics are required. Strong technical and preclinical/clinical background with demonstrated integration of PK/PD needs in the development of large and small molecules and cells if possible, as well as a track record of PK/PD contributions to innovative products' development demonstrated by preclinical /clinical publications, project leadership etc. is valuable.
Ability to forge strong collaborative working relationships with project teams as well as internal and external PK/PD groups and experience in successfully leading technical as well as clinical efforts that led to successful product development are a plus. Knowledge of product development life cycle and preparation of relevant PK/PD documents for regulatory filings in the US and Europe, significant experience in GLP, GMP and GCP requirements for pharmaceuticals and experience in supporting innovative therapeutics through various stages of development including commercialization are preferred. Ability to manage complex technical issues and acts decisively, ability to make complex issues and facts clear to others and impact outcomes with limited authority and ability to live with ambiguity and maintain focus on achieving key milestones and delivering to the organization are critical in this role. Utilizing a style that enhances the value of others, providing leadership in explaining the importance of PK/PD to preclinical and clinical colleagues, practicing credo values and behaving with honesty and integrity, treating others with dignity and respect are also desired.
Other abilities include excellent PK/PD technical skills, excellent influencing & communication skills, excellent organizational skills, exposure to change management, strong analytical skills and abilities, as well as high energy, a customer orientation (internal/external), and a personal passion and commitment to creating a high performance culture. This role requires about 10% travel and is based in Somerville, NJ. BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
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