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Director, Clinical Research-Inflammation Job
Date: Jul 21, 2010
Location: Princeton, NJ, US
Auto req ID 2517BR
Title Director, Clinical Research-Inflammation
Job Description Develop, implement and monitor Clinical Development Strategy and Clinical Development Plan (CDP) for a drug candidate and then help author and implement clinical studies (registrational Phase II and III trials) in therapies for chronic immune-mediated inflammatory diseases, working in a team setting, where effective interaction with highly skilled colleagues, and with internal and external stakeholders, is critical. Provide medical expertise in the therapeutic area with focus on a specific project and be the internal and external spokesperson for medical aspects of a given therapeutic area Provide medical and scientific support in other aspects of company activities in the assigned therapeutic area.
Member of Global Development Inflammation, the first headquarters' program to be sited in US, in Princeton. Reports directly to the Vice President, Medical & Science- Inflammation in NJ. Internal relationships also include working closely with Headquarters, Clinical Trial Operations, Outcomes Research, Statistics, Regulatory Affairs and Marketing and Sales organizations. External relationships will evolve with the drug candidate's development and will include expert advisory board members, investigators, other consultants, and key customer groups.
CLINICAL STUDY MANAGEMENT
•As chairman of the Medical & Science team, establish the Clinical Development Strategy and CDP of a drug candidate.
•Assume the overall medical responsibility during the execution of the Phase II and III studies described in the CDP
•Provide medical input, and act as the medical expert in the global project team, acting as the driving factor in the cross-organisational implementation of clinical strategies.
•Establish and maintain an external support network including investigators, key opinion leaders, and outstanding research scientists
•Establish relevant external advisory boards, in cooperation with relevant stakeholders
•Develop trial outlines and support the development of complete protocols. Cooperate in the development of other necessary documents, for clinical studies, e.g. IMPDs, CTAs, providing expert medical input throughout.
•Assist in identification and recruitment of investigators for clinical studies.
•Assure timely initiation of studies.
•Act as liaison with Regulatory, project teams, and investigators.
•Manage development of medical aspects of all protocol amendments/ deviations.
•Maintain close collaboration with Clinical Operations personnel involved in studies. Actively monitor clinical studies, providing full and timely support for all medical issues raised in the day-to-day activities of protocols, taking the lead in dealing with all medically related issues, especially adversities.
•Provide high-quality input at meetings and interactions with health authorities and in response to questions posed by health authorities worldwide.
•Generate high-level clinical documents for submission of new drug applications worldwide and experts' reports. Support post-submission activities to achieve regulatory approval and optimal labelling to allow successful launch of the drug
•Provide treatment algorithms if applicable
•Participate in Project core group and/or Global Project Team (GPT)
•Be a member of an asset project team, when appropriate
•Participate in relevant safety committees
•Perform Clinical Lab surveillance and all medical consistency checks
•Provide timely and authoritative medical support to Clinical Research, and cooperate fully with Clinical Research, to ensure appropriate trial execution, evaluation, and reporting
PROJECT MANAGEMENT
•Chair the cross-functional Medical- Scientific team of internal and, if required, external researchers involved in the different phases of drug development
•Through the project development team, assure timely initiation and completion of studies of qualified patients.
•Assist in developing clinical program time lines, budgets, and strategies.
•Provide medical input to, and assist in the updating of, Investigator's Brochure, PBPs and CDPs
•Ensure needed medical content of the individual study reports and publications
•Generate “story-line” for the clinical part of the submission dossier
•Generate high-level clinical documents for submission of new drug applications worldwide and Experts reports
•Present aspects of the Clinical Development Program of a given project at in- and external meetings
•Provide scientific support to NN Congresses, exhibitions and symposia
REGULATORY
•Write and/or review clinical sections of clinical/statistical reports, including investigator's brochures, INDs Pediatric Investigative Plans and NDA.
•Provide medical input to the design, updating and implementation of NDA database structures.
•Assume overall medical responsibility for the content and quality of the Clinical Part of the Submission Dossier
•Provide medical content of the individual study reports and publications based on results from the clinical development program
•Present medical aspects of the clinical development program at internal and external meetings (including regulatory agencies, congresses, investigator meetings etc.)
•Assist in providing medical representation at Regulatory meetings.
•Assist in the interpretation of regulatory guidelines and directives to judge risk and causality
MEDICAL AND SCIENTIFIC SUPPORT FOR OTHER COMPANY ACTIVITIES:
•Medical liaison with the Marketing/Business Developments. Support ongoing sales and marketing objectives by making presentations, as appropriate, to external groups, e.g. academic and community medical departments (grand rounds), professional associations, and P&T committees.
•Review medical content of company education of sales staff and promotional materials and be part of their educational program.
•Oversee company interactions with the expert community.
•Stay abreast of regulatory requirements and guidelines and current trends and medical practice in the fields of immunology, gastroenterology, and rheumatology, including reports and intelligence on key and critical new technologies or treatment advances.
•Represent NN medical department in regulatory interactions, investigators' and expert advisory board meetings, external professional societies, seminars, and conventions
•Must maintain necessary credentials and remain in good standing with the medical community and medical ethics boards.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
•M.D. or D.O. required
•4-6 years pharmaceutical experience preferred, especially with strategy and planning of trials involving monoclonal antibodies or other large proteins.
•Prior clinical research or related experience, e.g. monitoring the conduct of clinical studies and knowledge of Phases I through III.
•Documented clinical expertise in the field of auto-immunity is a definite advantage, especially in inflammatory bowel disease. Prior experience in SLE or rheumatoid arthritis is also very relevant.
•Documented ability to thrive within a matrixed organization
•Ability and willingness to quickly adjust to new situations in a continuously developing environment, in an international organization
•Good teamwork skills; the ability to accept coaching a must
•Fluent in written and spoken English with excellent communication skills.
•Proven presentation skills, with oral and written communication expertise
•High energy, excellent coordination and planning skills, considerable flexibility and a keen sense of quality and purpose.
Department CMR - GD INFLAMMATION (1)
Position Location Princeton, NJ
Job/Position State NJ
Degree Required Doctorate Degree Required
Percent Travel 20 - 30%
Title Director, Clinical Research-Inflammation
Job Description Develop, implement and monitor Clinical Development Strategy and Clinical Development Plan (CDP) for a drug candidate and then help author and implement clinical studies (registrational Phase II and III trials) in therapies for chronic immune-mediated inflammatory diseases, working in a team setting, where effective interaction with highly skilled colleagues, and with internal and external stakeholders, is critical. Provide medical expertise in the therapeutic area with focus on a specific project and be the internal and external spokesperson for medical aspects of a given therapeutic area Provide medical and scientific support in other aspects of company activities in the assigned therapeutic area.
Member of Global Development Inflammation, the first headquarters' program to be sited in US, in Princeton. Reports directly to the Vice President, Medical & Science- Inflammation in NJ. Internal relationships also include working closely with Headquarters, Clinical Trial Operations, Outcomes Research, Statistics, Regulatory Affairs and Marketing and Sales organizations. External relationships will evolve with the drug candidate's development and will include expert advisory board members, investigators, other consultants, and key customer groups.
CLINICAL STUDY MANAGEMENT
•As chairman of the Medical & Science team, establish the Clinical Development Strategy and CDP of a drug candidate.
•Assume the overall medical responsibility during the execution of the Phase II and III studies described in the CDP
•Provide medical input, and act as the medical expert in the global project team, acting as the driving factor in the cross-organisational implementation of clinical strategies.
•Establish and maintain an external support network including investigators, key opinion leaders, and outstanding research scientists
•Establish relevant external advisory boards, in cooperation with relevant stakeholders
•Develop trial outlines and support the development of complete protocols. Cooperate in the development of other necessary documents, for clinical studies, e.g. IMPDs, CTAs, providing expert medical input throughout.
•Assist in identification and recruitment of investigators for clinical studies.
•Assure timely initiation of studies.
•Act as liaison with Regulatory, project teams, and investigators.
•Manage development of medical aspects of all protocol amendments/ deviations.
•Maintain close collaboration with Clinical Operations personnel involved in studies. Actively monitor clinical studies, providing full and timely support for all medical issues raised in the day-to-day activities of protocols, taking the lead in dealing with all medically related issues, especially adversities.
•Provide high-quality input at meetings and interactions with health authorities and in response to questions posed by health authorities worldwide.
•Generate high-level clinical documents for submission of new drug applications worldwide and experts' reports. Support post-submission activities to achieve regulatory approval and optimal labelling to allow successful launch of the drug
•Provide treatment algorithms if applicable
•Participate in Project core group and/or Global Project Team (GPT)
•Be a member of an asset project team, when appropriate
•Participate in relevant safety committees
•Perform Clinical Lab surveillance and all medical consistency checks
•Provide timely and authoritative medical support to Clinical Research, and cooperate fully with Clinical Research, to ensure appropriate trial execution, evaluation, and reporting
PROJECT MANAGEMENT
•Chair the cross-functional Medical- Scientific team of internal and, if required, external researchers involved in the different phases of drug development
•Through the project development team, assure timely initiation and completion of studies of qualified patients.
•Assist in developing clinical program time lines, budgets, and strategies.
•Provide medical input to, and assist in the updating of, Investigator's Brochure, PBPs and CDPs
•Ensure needed medical content of the individual study reports and publications
•Generate “story-line” for the clinical part of the submission dossier
•Generate high-level clinical documents for submission of new drug applications worldwide and Experts reports
•Present aspects of the Clinical Development Program of a given project at in- and external meetings
•Provide scientific support to NN Congresses, exhibitions and symposia
REGULATORY
•Write and/or review clinical sections of clinical/statistical reports, including investigator's brochures, INDs Pediatric Investigative Plans and NDA.
•Provide medical input to the design, updating and implementation of NDA database structures.
•Assume overall medical responsibility for the content and quality of the Clinical Part of the Submission Dossier
•Provide medical content of the individual study reports and publications based on results from the clinical development program
•Present medical aspects of the clinical development program at internal and external meetings (including regulatory agencies, congresses, investigator meetings etc.)
•Assist in providing medical representation at Regulatory meetings.
•Assist in the interpretation of regulatory guidelines and directives to judge risk and causality
MEDICAL AND SCIENTIFIC SUPPORT FOR OTHER COMPANY ACTIVITIES:
•Medical liaison with the Marketing/Business Developments. Support ongoing sales and marketing objectives by making presentations, as appropriate, to external groups, e.g. academic and community medical departments (grand rounds), professional associations, and P&T committees.
•Review medical content of company education of sales staff and promotional materials and be part of their educational program.
•Oversee company interactions with the expert community.
•Stay abreast of regulatory requirements and guidelines and current trends and medical practice in the fields of immunology, gastroenterology, and rheumatology, including reports and intelligence on key and critical new technologies or treatment advances.
•Represent NN medical department in regulatory interactions, investigators' and expert advisory board meetings, external professional societies, seminars, and conventions
•Must maintain necessary credentials and remain in good standing with the medical community and medical ethics boards.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
•M.D. or D.O. required
•4-6 years pharmaceutical experience preferred, especially with strategy and planning of trials involving monoclonal antibodies or other large proteins.
•Prior clinical research or related experience, e.g. monitoring the conduct of clinical studies and knowledge of Phases I through III.
•Documented clinical expertise in the field of auto-immunity is a definite advantage, especially in inflammatory bowel disease. Prior experience in SLE or rheumatoid arthritis is also very relevant.
•Documented ability to thrive within a matrixed organization
•Ability and willingness to quickly adjust to new situations in a continuously developing environment, in an international organization
•Good teamwork skills; the ability to accept coaching a must
•Fluent in written and spoken English with excellent communication skills.
•Proven presentation skills, with oral and written communication expertise
•High energy, excellent coordination and planning skills, considerable flexibility and a keen sense of quality and purpose.
Department CMR - GD INFLAMMATION (1)
Position Location Princeton, NJ
Job/Position State NJ
Degree Required Doctorate Degree Required
Percent Travel 20 - 30%
Nearest Major Market: New Jersey
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