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Clinical Leader Experimental Medicine/Neurodegeneration
Requisition ID: 1700208649W
About Janssen Research and Development
- A therapeutic area focused end-to-end approach that incorporates research, early development, late development, life cycle management, and customer insights into one seamless strategy for all compounds in the pipeline. We will focus on five therapeutic areas with high unmet medical needs - Immunology, Oncology, Cardiovascular and Metabolism, Neuroscience, and Infectious Diseases.
- We will 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 will allow 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 will 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 will 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 will 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 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 Alzheimer’s disease, Mood Disorders, and Schizophrenia. Across neuroscience, our researchers are exploring the emerging science of synaptic plasticity and cellular resilience, with an emphasis on developing novel therapeutics for the treatment of severe mood disorders and neurodegenerative disorders.
The department of Experimental Medicine evaluates new molecular entities within the neuroscience therapeutic area. The department focuses on translational medicine, bridges between the preclinical stage and clinical trials, and designs and conducts clinical programs from first in human studies up to and including proof of concept trials in patients. Experimental medicine method development activities are also within the scope.
Position Role and Responsibilities
- Actively participate in developing and implementing strategies for the Alzheimer Disease Area Strongholds.
- Design and implement lean, appropriate and innovative early clinical development strategies for new chemical entities.
- Lead multidisciplinary clinical teams and collaboratively execute Phase I/IIa studies to evaluate proof-of-concept efficacy for novel drug candidates. Lead the preparation of clinical development plans and clinical study protocols, and contribute to informed consents, Investigator Brochures, and Ethics Committee and regulatory agency submissions.
- Review and evaluate clinical study safety, efficacy, and pharmacokinetic data.
- Contribute to the development and use of clinical biomarkers to facilitate early drug evaluations.
- Actively collaborate with preclinical research scientists; late-stage clinical development, regulatory, and commercial colleagues within Janssen.
- Collaborate with external experts to provide in-depth biomedical expertise and strategic guidance to the compound development teams.
- Contribute to in-licensing evaluations and due-diligence activities.
- Contribute towards translational science including preclinical models, in vivo imaging, qualification of biomarkers.
- Represent Janssen and contribute expert guidance and support to private-public partnerships devoted to neurodegenerative disease, such as ADNI, IMI, and EPAD.
- When acting as a safety physician: has ultimate responsibility for the medical management and safety aspects of the design, conduct and analysis of clinical studies for which they are responsible.
- Develop collaborative and consulting relationships with internal and external experts within the relevant scientific field.
- Design early clinical development strategies for compounds towards proof-of-principle and proof-of-concept studies. This includes the phasing and developing of appropriate clinical studies. Strategy will be developed in discussion with the preclinical project and early development teams, and in close collaboration with relevant members of the full development and commercial organizations.
- Align with all stakeholders proactively.
- Be an integrated and active member of the early development compound team for specific assets. Maintain a close relationship with other team members so that any data that may impact ongoing or future studies or functional activities are communicated within the team and beyond as appropriate.
- Develop and apply novel methodologies including in imaging, biomarkers, enrichment designs, challenge paradigms, and other novel technologies (such as ‘omics’ methods and pharmacogenetics) to expedite effective decision making. This may be through external collaborations, Discovery resources, or the in-house Biomarker group.
- Actively contribute towards the generation of required regulatory documentation - e.g. investigator’s brochure, regulatory submissions etc.
- Identify, evaluate and lead external collaborations.
- Accountable for all safety related activities, including defining the risk profile and risk mitigation strategies for compounds.
- Contribute towards the development and implementation of short and long term scientific strategies within neurodegenerative disorders.
- Active participation in external research activities and consortia with academia, biotech and industry.
- MD or equivalent with relevant experience with completed postgraduate training in neurology and/or psychiatry.
- Expert knowledge of and experience in neurodegenerative disorders is desirable.
- Knowledge of and experience with applied health science methods such as assay use and development, biomarkers of disease and pharmacology, discovery and/or development of therapeutics.
- Possess a good understanding of clinical pharmacology and quantitative methods including basic statistical tests and principles.
- Experienced in the writing and composition of scientific reports and manuscripts.
- The ideal candidate will have a good understanding of the drug development and clinical trial process in the pharmaceutical industry, based on experience derived from prior employment 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.
- Fluent in English (written and spoken).
Non-Technical Skills and Competencies
- Strong team integration and interpersonal skills. The ability to advise, persuade and negotiate with colleagues in a supportive and encouraging manner.
- High level of oral, written, and presentation skills.
- Broad sense of cultural sensitivity and diversity.
- Project management and leadership skills.
- Able to work within cross-functional team environments.
- Ability to work under pressure to meet deadlines.
- An ability to handle complex projects and to overcome delays and obstacles.
- Willingness and ability to travel, including trans-Atlantic travel.
- Willingness and ability to partially adjust work hours to facilitate global and trans-Atlantic collaborations.
Janssen Pharmaceutica N.V. (7555)
Clinical Research MD