Associate Director of Clinical Research (MD) - Inflammation / Respiratory 9/10/2016

Gilead Sciences, Inc Foster City, CA

Company
Gilead Sciences, Inc
Job Classification
Full Time
Company Ref #
34304
AJE Ref #
576130641
Location
Foster City, CA
Experience
Mid-Career (2 - 15 years)
Job Type
Regular

JOB DESCRIPTION

APPLY
SPECIFIC RESPONSIBILITIES

* The clinical research physician will play a key role at all stages of development for product programs from the drug discovery stage through product registrations world-wide.

* The successful candidate will have oversight for ongoing and planned product trials within the Inflammation therapeutic area.

* The Clinical Research MD will report to a more senior member of the Inflammation clinical team, who has direct responsibility for the overall research strategy and clinical and scientific development activities.

ESSENTIAL DUTIES AND JOB FUNCTIONS

* Will be part of a team responsible for all scientific aspects of conceptualizing and planning trials.

* Will be part of a team responsible for the preparation/review of regulatory documents, IND annual reports, IND safety reports, investigator brochures, and development plans.

* Provides ongoing medical monitoring for clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance.

* Ensures adherence to regulatory requirements of study conduct and industry standards of Good Clinical Practice.

* Coordinates the collection and analysis of clinical data for internal analysis and review.

* Will be part of a team responsible for managing the preparation and/or review of data listings, summary tables, study results, study reports, and clinical NDA sections.

* Prepares presentations for scientific conferences as well as for clinical study investigator meetings and expert advisory meetings.

* Develops manuscripts for publication in peer-reviewed journals.

* Will be part of a team responsible for defending the clinical development program before regulatory authorities.

* Serves as a scientific and clinical resource within Gilead Clinical Research

* Provides scientific and clinical guidance to Biology, Toxicology, Clinical Trials Management, Biometrics, Global Drug Safety, Regulatory, and Project Management staff.

* Assists in the clinical evaluation of business development opportunities.

KNOWLEDGE, EXPERIENCE AND SKILLS

MD or equivalent.

* Zero (0) to three (3) years experience with a proven success record in clinical research studies and trial design is required.

* Relevant industrial or academic experience in clinical research with basic understanding of Good Clinical Practices.

* Experience in Inflammation drug development.

* Ability to think analytically and strategically to formulate, develop, and execute clinical plans.

* Strong leadership skills with an ability to set vision, lead change, and mentor others.

* Ability to work effectively in a multidisciplinary team to cultivate an inclusive environment of respectful, open, and honest dialogue and to foster a robust sharing of ideas and creative problem solving.

* Excellent scientific written and oral communication skills.

* Facility with engaging internal and external experts in constructive scientific and clinical dialog around study design, study conduct, and interpretation of clinical results.

* Well-developed sense of integrity, strong work ethic, scrupulous attention to detail, clear ability to establish and maintain timelines, and persistent commitment to ensuring a high level of quality.

* Ability to travel domestically and internationally to company, scientific, regulatory, investigator, and other meetings (~20-30% travel expected).

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 careers@gilead.com for assistance.

For more information about equal employment opportunity protections, view the EEO is the Law poster at :
http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf