Trial Physician in Experimental Medicine Neuroscience - Janssen Pharmaceuticals - Anvers (ville)
Johnson & Johnson Family of Companies
Région
Anvers (ville)
‘Caring for the world, one person at a
time’... inspires and unites the people of Johnson & Johnson. We
embrace research and science - bringing innovative ideas, products and services
to advance the health and well-being of people.
Employees of the Johnson & Johnson Family of Companies work with
partners in health care to touch the lives of over a billion people every day,
throughout the world.
Experimental Medicine, Neuroscience
is
dedicated to bring New Molecular Entities (NME’s) derived from the discovery department
into the Clinical Phases. This entails a broad variety of clinical trials:
First-in-Human, Drug-Drug interaction, Bio-availability, PET imaging and Proof
of Concept trials both in healthy subjects and patients. We characterise the tolerability and safety of
a compound, pharmacokinetics and pharmacodynamics of a compound and wether the
latter has an impact on the defined indication. Our trials are crucial to decide
wether full development of a compound shall proceed.
Job description
The Trial Physician in Experimental
Medicine Neuroscience is a responsible member of the clinical team providing medical expertise
and medical oversight for the entire clinical trial, from initial
study design through final study close-out. The Trial Physician provides active
medical contribution to a cross-functional clinical team for each study
assigned in early development. The Trial Physician is responsible for the
medical monitoring, safety activities, assessment and understanding of drug
induced safety findings in light of patient safety for each assigned trial.
Main responsibilities
Responsible for all medical and safety aspects for the assigned neuroscience early development study(s)
Responsible for medical monitoring/reporting and evaluation of adverse events in early development clinical trials.
Act as the liaison between the clinical team and investigational site for all safety related aspects.
Provide safety/medical interpretation and reporting of clinical research results.
Takes responsibility for the the safety/medical aspects of the trial protocol and clinical study reports.
Close interactions with Clinical Leaders and Clinical Scientists across studies .
Qualifications
Education:
MD in relevant area with appropriate training and certification
Qualification
Experience in Clinical trial design, protocol development, medical monitoring, trial execution and regulatory filing is required.
At least 3 years of industry experience (or equivalent) in clinical research that has exposed the individual to the rigors of human trial conduct with pharmaceuticals or medical devices.
Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings is required.
Previous experience working on Clinical Trial and/or Compound Development Teams in a matrix management organization is desirable.
Working knowledge of the use of Microsoft suite of software products including Power Point and Word is required.
The successful candidate must be fluent in written and spoken English.
Willingness and ability to partially adjust work hours to facilitate trans-Atlantic collaboration.
The position is located in Beerse, Belgium and may require up to 20% travel (International as well as Domestic).
Growth opportunities
As Experimental Medicine Neuroscience
department, we value personal development. You will be supported in expanding
or strengthening your skills to enhance the personal development you pursue within
our department, within the Neuroscience therapeutic area or within the Johnson&
Johnson Family of Companies possible.
Primary Location
Belgium-Antwerp--
Organization
Janssen Pharmaceutica N.V. (7555)
Job Function
R&D
Requisition ID
2005800935W
time’... inspires and unites the people of Johnson & Johnson. We
embrace research and science - bringing innovative ideas, products and services
to advance the health and well-being of people.
Employees of the Johnson & Johnson Family of Companies work with
partners in health care to touch the lives of over a billion people every day,
throughout the world.
Experimental Medicine, Neuroscience
is
dedicated to bring New Molecular Entities (NME’s) derived from the discovery department
into the Clinical Phases. This entails a broad variety of clinical trials:
First-in-Human, Drug-Drug interaction, Bio-availability, PET imaging and Proof
of Concept trials both in healthy subjects and patients. We characterise the tolerability and safety of
a compound, pharmacokinetics and pharmacodynamics of a compound and wether the
latter has an impact on the defined indication. Our trials are crucial to decide
wether full development of a compound shall proceed.
Job description
The Trial Physician in Experimental
Medicine Neuroscience is a responsible member of the clinical team providing medical expertise
and medical oversight for the entire clinical trial, from initial
study design through final study close-out. The Trial Physician provides active
medical contribution to a cross-functional clinical team for each study
assigned in early development. The Trial Physician is responsible for the
medical monitoring, safety activities, assessment and understanding of drug
induced safety findings in light of patient safety for each assigned trial.
Main responsibilities
Responsible for all medical and safety aspects for the assigned neuroscience early development study(s)
Responsible for medical monitoring/reporting and evaluation of adverse events in early development clinical trials.
Act as the liaison between the clinical team and investigational site for all safety related aspects.
Provide safety/medical interpretation and reporting of clinical research results.
Takes responsibility for the the safety/medical aspects of the trial protocol and clinical study reports.
Close interactions with Clinical Leaders and Clinical Scientists across studies .
Qualifications
Education:
MD in relevant area with appropriate training and certification
Qualification
Experience in Clinical trial design, protocol development, medical monitoring, trial execution and regulatory filing is required.
At least 3 years of industry experience (or equivalent) in clinical research that has exposed the individual to the rigors of human trial conduct with pharmaceuticals or medical devices.
Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings is required.
Previous experience working on Clinical Trial and/or Compound Development Teams in a matrix management organization is desirable.
Working knowledge of the use of Microsoft suite of software products including Power Point and Word is required.
The successful candidate must be fluent in written and spoken English.
Willingness and ability to partially adjust work hours to facilitate trans-Atlantic collaboration.
The position is located in Beerse, Belgium and may require up to 20% travel (International as well as Domestic).
Growth opportunities
As Experimental Medicine Neuroscience
department, we value personal development. You will be supported in expanding
or strengthening your skills to enhance the personal development you pursue within
our department, within the Neuroscience therapeutic area or within the Johnson&
Johnson Family of Companies possible.
Primary Location
Belgium-Antwerp--
Organization
Janssen Pharmaceutica N.V. (7555)
Job Function
R&D
Requisition ID
2005800935W