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Job Field: Environmental Jobs
Location: United States, CA
Salary: $Not stated

JOB SUMMARY:

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<tr><td valign="top" width="450"><b>Job ID:00397203Job333of371Medical Director TDM1South San Francisco, CaliforniaJob factsJob functionClinical DevelopmentLocationUnited States - CaliforniaSouth San FranciscoCompany / DivisionPharmaceuticalsScheduleFull-timeJob typeRegular EmployeeJob levelExperiencedServiceDirect linkApply OnlinePrintWho We AreAt the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we''ve become one of the world''s leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.The PositionAs the Medical Director you will be responsible for the design, implementation, monitoring, analysis, and reporting of studies conducted within one or more programs. You will also participate in developing the long-range strategic plans for the molecule or molecules within the area of OncologyKey Accountabilities will be:Assisting the Medical Director in the overall management, planning, evaluation and documentation of projects and studiesParticipation in on-going medicine development activities including:* Preparation of regulatory documents and interaction with global regulatory authorities* Monitoring and reviewing incoming data* Analysis, presentation and interpenetration of on-going studies and published data* Interactions with health authorities and expert bodies* Close collaboration with drug safety, regulatory affairs, medical affairs and clinical trial operations* Participation in the preparation of abstracts, posters and presentations for scientific meetings and congresses* Developing and writing clinical plans and protocols ensuring that they are scientifically soundTo be successful in this role, you will have the following skills and experience:* Solid experience in medical research including writing clinical study reports and interpreting clinical data* Good communication and collaborative skills with experience at working with cross functional and external groups, including researchers, clinicians and other stakeholders.* Proven track record of delivery of experimental or novel studies* Confidence at presenting at internal and external strategy meetingsWho You AreMD (Board Certified Oncology/Medical Oncology) with clinical practice experience required (rare exceptions) and strong scientific/development competence in the relevant therapeutic area demonstrated by peer reviewed publications or production of clinical expert reports. Sub specialization in relevant therapeutic area (equivalent to board eligible or board-certified) is highly desirable.-     Minimum of 5 years experience in clinical research, at least 3 years must have been spent in the pharmaceutical industry. Must have past work experience of confirmatory drug development and evidence of having played a significant part in the preparation of international regulatory submissions or work with health authorities. Exceptional candidates without this level of filing experience may be considered on an individual basis. Work with health authorities in outcomes measures, presentations, negotiations and submissions are considered to be important.

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