Janssen’s vision is to transform patients' lives by discovering and developing innovative solutions to address the most important medical needs of our time. By delivering differentiated new treatments consistently and cost-effectively, we will also accelerate the growth of Johnson & Johnson's pharmaceutical business.
The Neuroscience Therapeutic Area is deeply committed to patients and to health care professionals and loved ones who care for them. Our research and development priorities are Neurodegenerative diseases, Mood Disorders (and related diseases), Schizophrenia and Glutamate related pathologies.
A therapeutic area focused end-to-end approach that incorporates discovery research, early development, late development, life cycle management, and customer insights into one seamless strategy for all compounds in the pipeline. We focus on five therapeutic areas with high unmet medical needs - Immunology, Oncology, Cardiovascular and Metabolism, Neuroscience, and Infectious Diseases.
We leverage our broad-based capabilities in biology, pharmacology, small molecule chemistry, biotechnology, and scientific and medical knowledge, and our global development organization across all five therapeutic areas. This allows our entire business to benefit from our science-driven approach to R&D, and, combined with our integrated global best practices, will promote flexibility and efficiency.
We augment our internal research with external innovation by implementing an open innovation scientific strategy to build collaborations with leading scientists in the world, and by continuing to strengthen our pipeline through strategic partnerships, and licensing and acquisitions.
We build close linkages with our medical affairs and commercial colleagues to ensure that we embed customer, physician, and payor insights into our compound development strategies to create optimal value and access for our products to ultimately benefit patients.
We leverage the depth and breadth of talent and expertise across our organization to help us meet the challenges that we face and will engage our workforce actively in building and shaping our future vision and organization.
The successful candidate will Oversee a broad portfolio of mood related early development projects, with input into cross-functional strategies. They Actively participate in developing and implementing strategies for the mood disease area stronghold. They will design and implements lean and innovative early clinical development strategies for new drug candidates. He/She will influence strategic decisions regarding therapeutic indications for new drug candidates from Phase I to POC
They will lead interdisciplinary clinical study teams and collaboratively conduct Phase I/IIa trials to evaluate proof-of-concept for new drug candidates. They will be responsible for the preparation of clinical development plans and clinical study protocols, and contributes to Investigator Brochures, and Ethics Committee and regulatory agency submissions.
- Provides highest level of scientific expertise through entire clinical trial process including interactions with basic research scientists; late-stage clinical development, regulatory, and commercial colleagues within Janssen Research & Development.
- Collaborates with external experts to provide in-depth biomedical expertise and strategic guidance to compound development teams and all levels of management.
- Responsible for the scientific content of status reports for upper management and clinical/project team use.
- Assists in the development, management, and tracking of project/program budgets.
- Acts as a senior internal expert with a direct impact on scientific and business objectives.
- Contributes to the development and use of clinical biomarkers to facilitate early drug evaluations.
- Contributes to in-licensing evaluations and due-diligence activities.
- Contributes towards translational science including preclinical models, in vivo imaging, and qualification of biomarkers.
- Reviews and evaluates preclinical and clinical study safety, efficacy, and pharmacokinetic data. Has ultimate responsibility for the medical management and safety aspects of the design, conduct and analysis of clinical trials for which they are responsible.
- MD with completed postgraduate training in psychiatry is required.
- A minimum of 10+ years relevant experience or equivalent by experience is required.
- Expert knowledge of and experience in moods disorder is required.
- Expert knowledge of and experience in biomarkers used for subject phenotyping and monitoring of disease progression in mood related diseases is required.
- Basic knowledge and understanding of clinical pharmacology.
- Good knowledge of quantitative methods including basic statistical tests and principles.
- Experience with writing scientific reports and manuscripts.
- Ability to critically evaluate research literature and presentations.
- Good understanding of the drug development and clinical trial process in the pharmaceutical industry, based on experience gained in pharmaceutical/biotech company or CRO.
- Consideration will also be given to candidates from academia with appropriate scientific credentials (including experience working with industry) and a strong motivation to transition into industry.
United States-California-San Diego-
Janssen Research & Development, LLC (6084)