Associate Director of Clinical Development (Non-MD) - Inflammation / Respiratory

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POST DATE 9/13/2016
END DATE 1/13/2017

Gilead Sciences, Inc Foster City, CA

Foster City, CA
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Mid-Career (2 - 15 years)
Doctoral Degree



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.


* 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.


* 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 for assistance.

For more information about equal employment opportunity protections, view the EEO is the Law poster at :