IMI EPAD Clinical Leader/ clinical leader experimental medicine-00000SIS
Description
About 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:
1. 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).
2. 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.
3. 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.
4. 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.
5. 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.
http://neuroscience.janssenrnd.com/
IMI EPAD [Innovative Medicines Initiative (IMI) - European Prevention of Alzheimer’s Dementia consortium (EPAD)]
Alzheimer’s disease (AD) is the leading cause of dementia globally affecting ~7M people in Europe. Attempts to impact on disease progression pharmacologically in symptomatic populations remain ongoing, but recent results have been disappointing. The key challenge is not only to develop new drugs but rather to accurately identify the high risk, asymptomatic individual suitable for trial inclusion who is willing to participate in secondary prevention studies. Risk may be modelled, defined, re-modelled and redefined on the basis of new data emerging from both trials and observational cohort studies and the capacity to engineer this remodelling is one of the two critical elements to the EPAD Programme. This though is subordinate to the second critical element which is the ability to make early, definitive and correct go/no-go decisions about continuing the development of an intervention or combination of interventions into confirmatory trials. A large scale, continuous, adaptive trial with multiple agents, multiple doses and across multiple arms is required that runs in a well characterized high risk population of people. The EPAD Project will develop a sustainable, pan-European scientific, analytical and adaptive trial delivery machine specifically and uniquely developed with the singular aim of undertaking Proof-of–Concept trials for the secondary prevention of Alzheimer’s dementia.
Objectives of the position (combining IMI EPAD and Exp. Med.) duties
IMI EPAD
• Represent EFPIA and Janssen Research & Development in the IMI EPAD consortium for clinical matters.
• Ensure that the sponsor’s obligations with respect to adequate clinical design/management are being upheld.
• Work closely with the Academic leads and the Janssen EPAD coordinator.
• Potentially co-lead work packages together with the academic co-leaders.
• Provide clinical, scientific and strategic guidance to the different work packages.
EXPERIMENTAL 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.
Qualifications
Profile
• MD with (industrial) experience in Neuroscience. Specialization in neurodegenerative disorders is desirable.
• Minimal 5 years of related experience.
• Having a good knowledge and understanding of clinical pharmacology, regulatory requirements, and preclinical drug testing.
• Having 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 (incl. experience in working with industry) and a strong motivation to move into the 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.
Primary Location:Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization: Janssen Pharmaceutica N.V. (7555)
Job Function: Clinical Research MD
Description
About 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:
1. 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).
2. 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.
3. 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.
4. 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.
5. 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.
http://neuroscience.janssenrnd.com/
IMI EPAD [Innovative Medicines Initiative (IMI) - European Prevention of Alzheimer’s Dementia consortium (EPAD)]
Alzheimer’s disease (AD) is the leading cause of dementia globally affecting ~7M people in Europe. Attempts to impact on disease progression pharmacologically in symptomatic populations remain ongoing, but recent results have been disappointing. The key challenge is not only to develop new drugs but rather to accurately identify the high risk, asymptomatic individual suitable for trial inclusion who is willing to participate in secondary prevention studies. Risk may be modelled, defined, re-modelled and redefined on the basis of new data emerging from both trials and observational cohort studies and the capacity to engineer this remodelling is one of the two critical elements to the EPAD Programme. This though is subordinate to the second critical element which is the ability to make early, definitive and correct go/no-go decisions about continuing the development of an intervention or combination of interventions into confirmatory trials. A large scale, continuous, adaptive trial with multiple agents, multiple doses and across multiple arms is required that runs in a well characterized high risk population of people. The EPAD Project will develop a sustainable, pan-European scientific, analytical and adaptive trial delivery machine specifically and uniquely developed with the singular aim of undertaking Proof-of–Concept trials for the secondary prevention of Alzheimer’s dementia.
Objectives of the position (combining IMI EPAD and Exp. Med.) duties
IMI EPAD
• Represent EFPIA and Janssen Research & Development in the IMI EPAD consortium for clinical matters.
• Ensure that the sponsor’s obligations with respect to adequate clinical design/management are being upheld.
• Work closely with the Academic leads and the Janssen EPAD coordinator.
• Potentially co-lead work packages together with the academic co-leaders.
• Provide clinical, scientific and strategic guidance to the different work packages.
EXPERIMENTAL 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.
Qualifications
Profile
• MD with (industrial) experience in Neuroscience. Specialization in neurodegenerative disorders is desirable.
• Minimal 5 years of related experience.
• Having a good knowledge and understanding of clinical pharmacology, regulatory requirements, and preclinical drug testing.
• Having 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 (incl. experience in working with industry) and a strong motivation to move into the 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.
Primary Location:Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization: Janssen Pharmaceutica N.V. (7555)
Job Function: Clinical Research MD