Medivation, Inc. (NASDAQ: MDVN – www.medivation.com), a publicly traded biopharmaceutical company located in San Francisco, is currently seeking a qualified, highly motivated individual for the position of Clinical Research Associate III, reporting directly to the Clinical Project Manager.

The company is currently focused on three programs in late stage clinical development, targeting large, unmet medical needs.  Dimebon is in two global Phase 3 trials in Alzheimer’s and Huntington disease.  The company’s second compound, MDV3100 is in two global Phase 3 trials in castration-resistant prostate cancer.

The successful candidate will have the skills necessary to thrive in a small company environment, as he/she assists Clinical Research staff in the conduct of clinical trial activities in accordance with Standard Operating Procedures and all applicable regulations governing the conduct of clinical trials. Particularly important skills include intelligence, logical thinking, ability to prioritize, “can-do” attitude, the ability to adapt quickly to changing business conditions, and strong interpersonal and team building skills.

Overall responsibilities for managing the full scope of clinical operations (protocol development to final report, regulatory filing and/or publications) and coordinating cross functional efforts in the administration and progress of a clinical trial(s) in order to achieve study objectives and corporate goals. 

ESSENTIAL FUNCTIONS
Essential functions include but are not limited to the following:

• Assist in managing defined aspects of clinical studies at Medivation to ensure studies are completed on time, within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines
• Perform the activities associated with the implementation and monitoring of clinical trials
• Oversee drug accountability at investigator sites and assist with the projection and management of both clinical and non-clinical supplies
• Assist in the preparation of clinical study reports, annual reports, IND updates, etc…
• Prepares and updates study drug forecasts
• Works with Medical Monitor and CPM to select investigative sites, train investigators and investigative site staff, preparation of materials for investigator meetings, clinical supplies
• Maintains study timelines.  Identifies and communicates study issues that will impact budget, resources and timelines. 
• Reviews and critiques CRF for accuracy and completeness.  Oversees data discrepancy management and assists with mapping as needed
• Provides training to internal and external customers as needed
• Makes recommendation on appropriate study vendor(s) to Director or CPM and manages vendor to achieve project goals
• Ensures that supportive study documents are completed (e.g., IVRS, specific scripts, non-clinical supply materials)
• Contributes to wider organizational goals and/or activities as assigned.

Desired Background and Experience:
BS/BA in Life Science or related discipline; or equivalent experience
3-5 years industry experience in drug development;
Phase III Oncology experience preferred but not required

Disclaimer
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Equal Employment Opportunity, M/F/D/V