Clincal Science Director
Pharmacyclics, Inc. - Sunnyvale, CA

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General Position Summary:
Assist in research and writing of clinical study protocols, patient informed consents, and other core documents which are central to clinical trial conduct

Coordinate Steering Committee meetings as well as independent DMC meetings

Assist clinical team addressing protocol questions, on study protocol related questions from clinical sites

Assist with protocol and study conduct training of CRAs, study coordinators, and investigators

Works with project management to coordinate review cycle process as appropriate

Assist with responding to regulatory questions as well as respond to site IRB or EC questions

Responsible for compiling clinical content and maintenance of various clinical components of regulatory documents, including Briefing documents/EOP2 packages/INDs/BLAs/NDAs

Assists in competitive intelligence and application to clinical protocol development

Serves as the clinical representative on various project subteams and addresses a broad range of problems.

Effectively collaborate with cross-functional internal groups and external partners, as well as work effectively with external key opinion leaders

Ensures that the clinical elements of documents are of quality, accuracy and format and comply with laws, regulations and corporate standards

Develop and maintain departmental processes, policies, SOPs and associated documents as needed

Education, Experience and Qualifications:
PhD, PharmD, MD or equivalent

Requires strong writing and verbal communication skills

Requires ability to work closely and effectively across functions

Requires knowledge and experience in clinical trial conduct

Pharmacyclics, Inc. - 18 months ago - save job - block