Associate Director of Clinical Development (Non-MD) - Inflammation / Respiratory 9/13/2016
Gilead Sciences, Inc
Foster City, CA
JOB DESCRIPTIONAPPLY SPECIFIC RESPONSIBILITIES
This position will play a key role in Inflammation clinical development. Working in collaboration with the Clinical Research lead, the position is responsible for various aspects of ongoing clinical trial program-related activities within the Inflammation therapeutic area. These activities include, but are not limited to, program planning, integration of functional area activities during program implementation, clinical study execution, data analysis/reporting and NDA/MAA filings.
ESSENTIAL DUTIES AND JOB FUNCTIONS
* Working in collaboration with the project(s) Clinical Lead and assigned Project Management staff, supports overall planning and implementation of assigned development program(s)
* Interfaces with departmental staff to share scientific and clinical information and ensure implementation of consistent and best practices.
* Supports protocol review discussions concerning scientific and procedural aspects of study design, and integration into the overall program plan.
* Serves as resource for non-clinical research staff concerning program related questions and issues.
* Adheres to strict regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.
* Contributes to the development of study protocols, amendments, specific sections of study manuals and Investigator meeting notebooks, and other documents as needed.
* Provides writing and review function for clinical aspects for regulatory documentation, INDs, IND annual reports, IND safety reports, Investigator Brochures, NDAs/MAAs, product labeling .
* May contribute to the design and development of Case Report Forms, Data Management Manuals and Data Analysis Plans, as required.
* Helps insure consistency across protocols. Presents scientific information if needed.
* May contribute to the preparation and/or review of data listings, summary tables, and study results.
* Writes and/or provides critical review for scientific presentations (abstracts, orals and posters) and manuscripts for publication.
* Determines the functions most critical to company success and supports priorities within functional area.
* Anticipates fairly complex obstacles and client difficulties and implements solutions that meet goals.
KNOWLEDGE, EXPERIENCE AND SKILLS
* Pharm.D or Ph.D. in a relevant field with 7-10 years related experience, with knowledge of clinical development and product registration, is preferred.
* Excellent verbal and written communication skills and interpersonal skills are required to maintain working relationship with team members to ensure scientific integrity of clinical studies.
* Must be able to design and use all available vehicles for effective scientific communication within the company.
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact firstname.lastname@example.org for assistance.
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