Oslo, Clinical Research Manager

Clavis Pharma ASA is a clinical-stage oncology focused pharmaceutical company based in Oslo, Norway with a portfolio of novel anti-cancer drugs in development. These patented New Chemical Entities are novel, improved versions of widely used and commercially successful drugs, made using Clavis Pharma's Lipid Vector Technology chemistry. Data generated suggest these potential breakthrough products may offer improved efficacy and reduced side effects through enhanced pharmacokinetic properties, greater tissue penetration, altered metabolism and, in certain cases, additional modes of action.  The Company has three drug candidates in formal development studies: Elacytarabine, a leukaemia drug, currently in a randomised, controlled Phase III study (CLAVELA) in late-stage acute myeloid leukaemia; CP-4126 (also known as CO-1.01), in a Phase II randomised comparative study (LEAP) with gemcitabine for the treatment of pancreatic cancer; and CP-4200, an azacitidine derivative, will be in Phase I for treatment of myelodysplastic syndromes second half 2011.

Will you join us in developing new and improved drugs for treatment of cancers?

Medical Advisor – Oncology / Haematology
Our projects are advancing, and we are looking for a physician to strengthen our Clinical R&D team. Our new Medical Advisor will provide essential medical knowledge and support to our clinical studies and projects. You are able to work independently and in teams, and have the ability to take initiative and finalize assignments and projects as agreed. The position is Oslo based, and will report to the Chief Medical Officer (CMO).

Responsibilities

• Pharmacovigilance, medical assessments, safety signalling activities, and trend analyses
• Medical assessments related to safety reporting in ongoing clinical studies
• Collaborate in the development of safety reports and risk management plans
• Manage a clinical study or other development activities/projects
• Provide medical review and input to investigator’s brochures, clinical study protocols, clinical study reports etc.
• Remain informed of current developments with pertinent medical and scientific communities through familiarity with current literature, attendance at meetings, conventions, professional associations etc.
• Work closely with  the CMO to provide medical guidance and internal training to Clavis R&D projects
• Participate actively in the day-to-day activities in the clinical department, including extensive collaboration with external service providers

Preferred background

• Physician with clinical experience in oncology; haematology would be advantageous
• At least two years experience in pharmaceutical product development at an international level, in particular within safety / pharmacovigilance, and preferably within oncology / haematology
• Good working knowledge of ICH guidelines, GCP, and current safety reporting requirements
• Experience in safety related signalling activities and trend analysis
• Industry / Academic experience in planning, executing, and reporting clinical studies is essential
• Strong team working skills across departments and excellent networking capabilities
• Excellent initiative; driven by the sense of urgency
• Strongly motivated with high energy levels
• Results driven with entrepreneurial spirit
• Strong interpersonal, verbal and written communication skills
• Fluency in English is required. One Scandinavian language is preferable

Contact persons:
Athos Gianella-Borradori, Chief Medical Officer, e-mail: ******
Kjell Hernes, Safety officer / Clinical Research Manager, e-mail: ******

We can offer

• A challenging and exciting teamwork environment in a growing pharmaceutical company
• Opportunities for personal and professional development
• Extensive international network
• Competitive terms
• Offices centrally located in Oslo

For more information, please see:
Send your brief application with CV within 9 May to Bente Y. Robertsen (******)..
Clavis Pharma ASA, Parkveien 53 B, NO-0256 Oslo, Norway
Tel: +******  Fax: +******
 clavispharma.com • ******

Merk din ansøkan med Karriereguiden.no