Medical Director Rheumatology
Date Posted: Wednesday, 22nd of February 2012
Salary: Competitive
Start Date: ASAP
Telephone: 01438 743047
Location: Switzerland
Discipline:Pharmacovigilance
Consultant Name: Moin Din
Description
Medical Director - Rheumatology - Switzerland
This company is the division for innovative small molecules and biopharmaceuticals of the company. Its Headquarters in Switzerland, consist mostly of Research, Clinical, Marketing, Support Functions and the Divisional Management.
Description
PURPOSE OF THE ROLE
Act as Leader of clinical development strategies for rheumatology products with particular emphasis on osteoarthritis.
Medical Director to develop and execute Clinical Development strategy.
Provide scientific expertise/input to Business Development activities, to launch/post launch activities and Marketing strategies, to Medical Communications, Exploratory Medicine, Preclinical Pharmacology, and Global Drug Safety related to this therapeutic area.
KEY TASKS & RESPONSIBILITIES
Functional Tasks
Act as medical director of clinical development strategies with regard to current and future rheumatology development;
Develop (or support development) and propose the Clinical Development Plan for assigned product(s);
Provide medical/scientific input and drive the creation of relevant clinical documents or parts thereof to ensure high quality of e.g., study concept sheets, study protocols and reports, Investigator Brochures, submission/registration documents, publications, etc;
Review and sign off all clinical documents related to the clinical studies (e.g. study protocols and study reports) within area of responsibility;
Oversee allaspects related to the scientific and medical risks in collaboration with the safety representative;
Supervise the review, analysis and interpretation of study data;
Support communication of study results as assigned;
Collaborate with Clinical Trial Management members in the selection of principal investigators and recruitment of clinical study sites.
MAIN INTERFACES (in alphabetical order)
INTERNAL: Biostatistics, Business Development, Business Unit/Marketing, Chief Medical Officer, Clinical Trial Management & Monitoring, Data Management, Drug Safety, Exploratory Medicine, Legal, Medical Information, Medical Writing, Project Management, Regulatory Affairs, R&D Quality Assurance
EXTERNAL: Health Authorities, Opinion/Thought Leaders, Clinical Investigators, Academic Institutions, Scientific and Patients’ Organizations
Qualifications
CANDIDATE’S PROFILE
EDUCATION/LANGUAGES
Medical Doctor (MD) specialized in the therapeutic area with experience in direct patient care
Global recognition as expert in clinical drug development with sound knowledge in osteoarthritis or cartilage injury development
Fluency in English
PROFESSIONAL & TECHNICAL SKILLS
Solid experience in pharmaceutical product development within the pharmaceutical and/or biotech industry at an international level
Strong immunology or osteoarthritis background preferred
Extensive experiences in interaction with Health Authorities in US, Europe and possibly Japan and/or China
Experience in NDA / MAA filing would be an asset
Ability to work and manage people in a matrix environment
CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL23615 in all correspondence.
