Clinical leader Experimental Medicine/ neurodegenerative diseases Job

Job description

Clinical leader Experimental Medicine/ neurodegenerative diseases-00000T33DescriptionAbout Janssen R&D:Our 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.
Our strategy consists of five key elements:
- 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 our pipeline. We will focus on five therapeutic areas with high unmet medical needs
- immunology, oncology, cardiovascular and metabolism, neuroscience (including pain), and infectious diseases (virology and antibiotics).
- 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 in 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 with these conditions and to the health care professionals and loved ones who care for them. Our research priorities are Alzheimer’s disease, Mood Disorders, Schizophrenia and Pain. 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 dementias.
The department of Experimental Medicine evaluates new molecular entities within the neuroscience therapeutic group. The department focuses on translational medicine, bridges between the preclinical stage and the clinical trials, and designs and conducts clinical programs from first in human trials up to and including proof of concept trials in patients. Method development activities are also within the scope of the department.http://neuroscience.janssenrnd.com/Objectives of the positionEXPERIMENTAL MEDICINE NEUROSCIENCE
- Design and implement lean, appropriate and innovative early clinical development strategy for new drug candidates.
- Lead interdisciplinary clinical study teams and collaboratively conduct Phase I/IIa trials to evaluate proof-of-concept for new 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 basic research scientists; late-stage clinical development, regulatory, and commercial colleagues within Janssen Research & Development.
- Collaborate with external experts to provide in-depth biomedical expertise and strategic guidance to 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, and theranostic research.
- When serving as a safety physician: has ultimate responsibility for the medical management and safety aspects of the design, conduct and analysis of clinical trials for which they are responsible.
- Actively participate in developing and implementing strategies for the Alzheimer Disease Area Strongholds.
Main Accountabilities
- Develop collaborative and consulting relationships with internal and external experts within the field
- Design the early clinical development strategy for specific compounds towards proof-of-principle and proof-of-concept. This includes phasing and developing the clinical studies. This strategy will be developed in discussion with the preclinical Project team and Early Development team of the compound, and in close collaboration with relevant members of the Full Development and Early Commercial organizations.
- Align with all stakeholders proactively.
- Be an integrated and active member of the early development compound team for Janssen specific assets. Maintain a close relationship with the 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 vivo imaging, biomarkers, enrichment designs, challenge paradigms, and other novel technologies (such as ‘omics’ methods and pharmacogenetics) to expedite effective decision making in early development.
- Active contribution towards the generation of necessary documents
- e.g. investigator’s brochure, regulatory submissions.
- Evaluate and manage external collaborations.
- Responsible for all safety related activities (including defining the risk profile and risk mitigation strategies for compounds in early development.
- Contribute towards the development and implementation of short and long term scientific strategies in neurodegenerative disorders.
- Active participation in external research activities and consortia with academia, biotech and industry.
QualificationsProfile
- MD with completed postgraduate training in neurology
- Expert knowledge of and experience in neurodegenerative disorders such as Alzheimer’s Disease is highly desirable (minimum 3 years).
- Knowledge of and experience with applied health science methods such as assay use and development, discovery and/or development of therapeutics.
- Having a basic knowledge and understanding of clinical pharmacology.
- Good knowledge of quantitative methods including basic statistical tests and principles.
- Experience with 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 gained in pharmaceutical/biotech company or CRO.
- Consideration will also be given to candidates in academia with the appropriate scientific credentials (including experience working with industry) and a strong motivation to move into industry.
- Fluent in English (written and spoken).Non-Technical Skills and Competencies
- Good team member and interpersonal skills.
- The ability to advise, persuade and negotiate with colleagues in a supportive and encouraging fashion.
- Good oral, written, and presentation skills.
- Good sense of cultural sensitivity and diversity.
- Appropriate project management skills.
- Being able to work in a cross-functional team environment.
- Ability to work under pressure to meet deadlines.
- An ability to handle complex projects and to overcome delays and obstacles.
Other Requirements
- Willingness and ability to travel abroad, including trans-Atlantic travel.
- Willingness and ability to partially adjust work hours to facilitate trans-Atlantic collaboration.
What’s in it for you…?“Caring for the world, one person at a time…”As an employee we consider you as our most valuable asset. We take your career seriously.
As part of a global team in an innovative environment your development is key and our day-to-day responsibility.
Through e-university, on the job training, various projects and programs, we ensure your personal growth.
Our benefits make sure we care for you and your family now and in the future.
Primary Location:Europe/Middle East/Africa-Belgium-Antwerp-BeerseOrganization: Janssen Pharmaceutica N.V. (7555)Job Function: R&D