Director 1, research & development job

Company Name:
J&J Family of Companies
A global leader in pharmaceutical R&D;, Janssen's Research & Development develops treatments that improve the health and lifestyles of people worldwide. Since 2009, the Company focuses on 5 therapeutic areas: neuroscience, immunology, oncology, infectious diseases and vaccines, cardiovascular/metabolic disorders.
Janssen Infectious Diseases is committed to provide a finite treatment for chronic HBV disease that will achieve long term immune control. It expects to achieve this through combinations of treatment modalities that address critical drivers of disease at the level of the viral lifecycle and of the host response. Programs addressing this issue are moving into early development while preclinical and clinical studies are identifying and evaluating biomarkers for efficacy for early proof-of-concept and strategic patient segmentation in treatment combination build up and optimisation.
The HBV Translational Medicine Leader will address the scientific, clinical and operational challenges of moving the HBV discovery programs to clinical proof-of-concept within the setting of the critical strategic and the operation teams of the Infectious Diseases Therapeutic Area. Special attention will have to be given how preclinical MOA knowledge will drive early combination treatment approaches and patient segment selection for POC that will nucleate the buildup of leading curative HBV. This includes the integration and validation of new biomarkers, the effective use of adaptive design scenario's using preclinical and clinical modeling expertise, the accommodation of key expert and regulatory views on proposed scenario's, and the orchestration within the evolving configuration of the operational support capabilities (GDO/CSO) while interfacing with China R&D; counterparts for the clinical programs on Asian patients.
The candidate will provide the scientific, medical and clinical development insights and participate in the decision making of the Hepatitis Disease senior end-to-end strategy driver team composed of senior commercial and R&D; leaders
The successful candidate will be defining target patient population and relevant clinical endpoints for early development. She/he will be responsible for the elaboration of i
investigator brochures, clinical development plan, data analysis reviews, presentation for internal and external meetings.
They will also be responsible for establishing with the clinical early development medical staff the relevant trial protocols and the orchestration of the above components within the evolving configuration of the operational support capabilities (Global Development Organization)
The candidate will support the integration of translational research on biomarkers including the analytical and clinical validation strategy for patient response and stratification. Clinical validation can include the setup of observational studies and analytical validation through the enlistment of the support of the Janssen Diagnostic Centre of Excellence.
In addition, they will assist commercial evaluation by providing understanding of disease epidemiology and medical needs in relationship with existing therapeutic choices and practices and by relaying input of key medical experts and participate in Business Development and Licensing activities.
The successful candidate will MD PhD, PhD. in immunology, pharmacology or related biosciences, postdoctoral experience and 4+ years of relevant industry experience.
The candidate will have functioned as a leader in exploratory clinical translational research in HBV or related immune mediated diseases
The candidate will have a working knowledge of clinical development , if not in hepatitis B, in immune/inflammatory disorders. In addition, they will have a solid understanding of the implementation of biomarker implementation in early development.
And a demonstrated scientific, administrative, and project management capabilities in interacting with discovery, preclinical translational research, clinical pharmacology and biostatistics.
The candidate will have experience with establishing and managing academic research collaborations and effective written communication skills and solid interpersonal skills with ability to work in team- and matrixed environments.
Primary Location: North America-United States-New Jersey-Titusville
Organization: Janssen Research & Development, LLC. (6084)
Job Function: R&D;
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Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
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Req ID
Date: Wed, 20 08 2014 00:00:00 GMT
Country: US
State: NJ
City: Titusville
Postal Code: 08560
Locale: en_US

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