Clinical Program Manager - Hepatitis

Company:	Gilead Sciences, Inc. Company Profile \| Current Opportunities (140)
Job Location(s):	Foster City
Employment Term:	Regular
Employment Type	Full Time
Start Date:	As soon as possible
Starting Salary Range:	Not Provided
Required Experience:	Open
Related Categories:	Healthcare - Practitioner/Technician

Position Description

Job Posting Title:	Clinical Program Manager - Hepatitis
Requisition Number:	4920
Country:	US
State:	California
Job Location:	Foster City
Functional Area:	CLINICAL
Position Type:	Regular
Full-Time / Part-Time:	Full-Time
Shift:	Days
Specific Responsibilities:	This positions supports Hepatitis B/C development located at our corporate campus in Foster City, California - SF Bay Area. Typically requires a BS or BA in a relevant scientific discipline and minimum 8 years relevant clinical experience in the pharmaceutical industry or equivalent.
Essential Duties and Job Functions:	Must meet all requirements for Principal Clinical Research Associate position and have demonstrated proficiency in all relevant areas. Provides guidance and oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines. Responsible for development and monitoring of study budgets and timelines. Partners with functional peers to manage, adjust, and revise project timelines/budgets as necessary. Develops RFPs, select CROs/vendors, and manages external resources. Communicates project status and issues and ensure project team goals are met. Participates in development of SOPs, Clinical Study Reports, INDs, NDAs, and other clinical, regulatory, safety documents. Contributes to development of abstracts, presentations, and manuscripts. Recruit, hire, mentor, and manage CPA/CRA direct reports and support their professional development. Participate in training of CPAs and Crass. Successfully develops, implements, and completes clinical trials. Manages designated program budget and timelines. May determine activities critical to company success and priorities within functional area. Anticipates moderately complex obstacles and client difficulties and implements solutions to achieve project goals. May design and use all available vehicles for scientific communication within company. With limited supervision may participate in or lead departmental strategic initiatives. Travel is required.
Knowledge, Experience and Skills:	Excellent interpersonal skills, and demonstrated ability to lead is required. Experience in managing staff as well as mentoring and developing junior staff is required. Strong communication and influence skills and ability to create a clear sense of direction is necessary. Must be able to resolve problems using national and international regulations, guidelines, and investigator ineration. Must have a demonstrated ability to successfully develop, implement, manage and complete clinical trials. Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is required. Experience in developing RFPs and selection and management of CROs/vendors. Ability to write study protocols, study reports, sections for investigator brochures, and regulatory documents (e.g. IND, DNA, etc.) with little supervision. Ability to examine functional issues from a broader organizational perspective. Ability to participate in and/or lead departmental or interdepartmental strategic initiatives under limited supervision. Functional expertise to initiate, author, or contribute to SOP development, implementation, and training.