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Roche
Associate Clinical Director Virology/Tamiflu
Location: Nutley,
New Jersey-Northern
07110
Posted on:
9/29/2009 10:28:44 AM
Postion type:
Full time
Job Code:
00016162
Required Education:
Salary:
DESCRIPTION
Assists the Clinical Science Leader in all areas of project and study planning, evaluation, documentation including IND and annual report, clinical NDA preparation and protocol preparation. Is responsible for at least one study (in all aspects), working with Tamiflu.
Principal functional responsibilities:
Assists in the timely medically and scientifically sound development of the clinical portions of a product development plan (PDP) the quality and timely preparation of all PDM documents submitted for approval GCP, Clinical Operating Guidelines and Standard Operating Procedures are followed within PDC and liaises with appropriate departments inside and outside PDC to define the timing of discussion with the FDA and other regulatory bodies on format of clinical NDA and submission issues.
Preparation of clinical progress reports for regulatory agencies before they are reviewed by line-managers and assures the consistency of labeling and package insert (clinical section) with database.
The preparation and contents of annual reports and safety updates and ensures corrects data interpretation including interim and Final Study Reports before they are approved and assumes protocol authorship, selects the efficacy parameters, defines the range of laboratory marked abnormality values and acceptable laboratory reference values and assumes the development and writing of protocols.
Task priorities and schedules within a project as well as time schedule in view of the next assessment point for PDM relevant sections or selects, in liaison with other departments, suitable clinical consultants when required and represents PDM at monitoring workshops when required and contributes to Project Specific Manual for clinical sections and assures that the SOPs for evaluation, documentation and reporting of SAEs are strictly followed within PDM and together with PDS assesses the etiology/causality of SAEs and laboratory abnormalities and liaises and communicates with Marketing and co-ordinates clinical efforts on the project related issues.
Preparation of abstracts, posters, oral communication for scientific meetings reviewing license applications as requested by Group Leader and contributes to the career development plans of his/her collaborators and actively ensures that they receive appropriate management and technical support and training. Contributes to orientation and training for employees and signals further educational or training requirements and selects, interviews and makes hiring recommendations in reporting area and conducts performance appraisals of subordinates.
REQUIREMENTS:
MD or comparable clinical qualification, with clinical experience ininfectious diseasepreferred.
Experience in clinical research, preference will be given to candidates with clinical research experience in Pharmaceutical industry. Significant experience in clinical research, with preference for candidates with experience as a clinical investigator in the area of viral diseases and pediatric clinical trials.Excellent written and verbal communication skills with fluency in English
Ability to work effectively within a multifunctional matrix team structure in acorporate work environment.
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