Expert Clinical Manager / Clinical Trial Head

Description Novartis Oncology – Join an Industry LeaderAt Novartis Oncology, our mission is to become the world’s premier oncology company by consistently discovering, developing and producing broadly available novel therapies that improve and extend the lives of cancer patients.Our portfolio provides a broad range of innovative therapies and practical solutions that enhance the lives of patients and their families.  Our efforts to discover and develop innovative approaches for the treatment of cancer have produced breakthrough medicines such as the leukaemia therapy Gleevac®/ Glivec®; the breast cancer agent Femara® and Zometa® for the treatment of cancer-related bone complications.At this time, we are looking for both Expert Clinical Managers and  Clinical Trial Heads for our NJ, MA and Switzerland offices.  An Expert Clinical Manager serves as a Clinical Trial Leader for selected trials in Novartis Oncology. Responsible for preparation and delivery of Clinical Trial Protocol Summaries under minimal supervision. Makes recommendations regarding monitoring safety, eligibility, enrollment and data consistency. Contributes to overall trial processes and programs including continuous improvement process.The Clinical Trial Head serves as a Clinical Research Manager and Clinical Trial Leader for selected trials, including support to other Clinical Trial Leaders. Managers are responsible for overall process and projects and are expected to help design and contribute to continuous improvement processes. Responsible for preparation of Clinical Trial Protocol Summaries and Clinical Trial Protocols. Make recommendations regarding monitoring safety, eligibility, enrollment and data consistency. Requirements Expert Clinical Manager - Phase I Oncology clinical trial experience is a requirement. On an exception basis highly-qualified candidates with strong oncology experience with Phase 2/3 clinical trial experience might also be considered. Candidates should have 3-5 years of experience in clinical environment (2+ pharma). University degree in Biological Sciences/Nursing/Pharmacy is a minimum. Candidates must demonstrate: * strong oral and written communications skills and experience in medical scientific writing protocols and Clinical Trial Reports independently * experience and ability to recognize safety and efficacy data trends independently * knowledge of clinical trial design, statistics and pharmacokinetics * experienced with all aspects of the drug development process * knowledge of medical, scientific and clinical research techniques of the assigned areas * knowledge of GCP and local regulatory requirementsClinical Trial Head - Phase I Oncology clinical trial experience is a requirement. Candidates should have 5+ years of experience in clinical environment (2+ pharma). University degree in Biological Sciences/Nursing degree/Pharmacy is a minimum. Advanced degree or equivalent experience preferred. Candidates must demonstrate: * ability and prior experience writing protocols and Clinical Trial Reports independently * excellent medical-scientific writing skills * ability to assess and recognize safety and efficacy data trends independently * excellent knowledge of clinical trial design, statistical and pharmacokinetics * thoroughly familiar with all aspects of the drug development process * deep knowledge of the medical, scientific and clinical research techniques and processes * strong knowledge of GCP and local regulatory requirementsAll successful candidates will posses a strong professional drive and commitment to excellence, ability to work effectively in a team, and have a comfort level working in a global, highly matrixed environment with a strong performance-driven culture Link to Novartis Pharmaceuticals opportunities Send this Job to a Friend EEO Novartis is committed to embracing and leveraging diverse backgrounds. Novartis is an equal opportunity employer M/F/D/V.