Sr. Manager, Medical Affairs - HCV

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POST DATE 8/9/2016
END DATE 10/15/2016

Gilead Sciences, Inc Foster City, CA

Company
Gilead Sciences, Inc
Job Classification
Full Time
Company Ref #
33838
AJE Ref #
575818789
Location
Foster City, CA
Experience
Mid-Career (2 - 15 years)
Job Type
Regular
Education
Bachelors Degree

JOB DESCRIPTION

APPLY
SPECIFIC RESPONSIBILITIES

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia. We have the following exciting opportunity in our Foster City, CA location:

ESSENTIAL DUTIES AND JOB FUNCTIONS

Essential Duties and Job Functions

* Support the development of clinical data through Medical Affairs Sub-Team to include Gilead-sponsored, investigator-sponsored and collaborative studies

* Assist in assigned aspects of study management for HCV investigator-sponsored and collaborative trials. Develop and track quarterly and annual reports for the HCV Phase 4 Studies Program

* Provide scientific expertise into study concepts; participate in building study synopsis, protocols, and other study documents; and liaise with affiliates and investigators

* Maintain regular contact with investigators to track study progress and publication deliverables; liaise with Scientific Communications colleagues to share information regarding planned publications

* Review abstracts, manuscripts, posters and oral presentations for Gilead-sponsored, investigator-sponsored and collaborative studies; collate Gilead Sciences review comments and share with external author(s) and internal review committees

* Serve as an information resource to Gilead colleagues, including the Medical Scientists, regarding viral hepatitis and related investigator-sponsored/collaborative studies

* Assist with Gilead-sponsored Phase 4 studies

* Participate in the HCV Publications Subteam to share information on anticipated publications from Gilead HCV phase 4 studies; maintain study timelines

* Provide strategic input to US Medical Plan of Action, and monitor performance against HCV team annual goals and objectives

* Prepare presentation materials and present scientific data at Internal and External Meetings involving Medical Affairs (e.g., including at Advisory Boards and Investigator Meetings)

* Serve as an educational resource to both medical and commercial disease and product training

* Provide medical and scientific leadership at key scientific meetings involving HCV e.g., AASLD, EASL

* Lead the medical affairs review of promotional material for HCV (Promotional Review Committee)

* Lead the medical affairs review of drug safety materials for HCV

* Develop effective working relationships with internal and external customers, including Clinical Research, Biometrics, Commercial and Marketing, Contracts/Finance, Virology, Pharmacology, Legal, Medical Scientists and other Gilead Medical Affairs colleagues, Medical Directors/Medical Managers in affiliate offices, investigators, research organizations

* Other activities, as assigned, to support HCV Medical Affairs

KNOWLEDGE, EXPERIENCE AND SKILLS

Knowledge, Experience and Skills

* Experience in infectious diseases, virology or clinical virology is desirable.

* Experience in clinical patient care

* Experience in developing effective abstracts, manuscripts, posters and slides and presenting at scientific meetings

* Excellent organizational skills to support project planning across multiple activities, anticipate and prioritize workload

* Excellent written, verbal and interpersonal, relationship-building and negotiating communication skills

* Excellent analytical skills, demonstrated ability to identify and understand complex issues and problems and identify and query key findings from study data and publications

* Excellent teamwork skills. Organized; attention to detail and able to meet timelines in a fast-paced environment

* Ability to suggest solutions for issues encountered with clinical studies and other projects in area of responsibility

* Able to work with a level of autonomy and independence

* Must be fully cognizant and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities; thorough knowledge of FDA regulations, ICH guidelines and GCPs governing the conduct of clinical trials



Education

M.D., D.O., PhD (biological or pharmaceutical sciences) or PharmD; with greater than 3 years Industry experience in Medical Affairs, Clinical Development, or Research; clinical trials management, scientific expertise desirable

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, please view the EEO is the Law poster.

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