Job Details: Sr Director, Clinical Research


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Sr Director, Clinical Research
Gilead Sciences is continuing to hire for all open roles. Our
interview process may be conducted virtually and some roles will be
asked to temporarily work from home. Over the coming weeks and months,
we will be implementing a phased approach to bringing employees back
to site to ensure the health and safety of our teams.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.
Job Description

The Sr Director MD, Clinical Research, position will design, conduct,
and evaluate Phase 1, 2, and 3 clinical trials and provide scientific
expertise on pediatric viral infectious diseases.

ESSENTIAL FUNCTIONS:

* Interfaces with staff to share scientific and clinical information
and consistent practices.
* Leads/supports protocol review discussions concerning scientific
and procedural aspects of study design.
* Serves as resource for junior staff.
* Oversees the scientific aspects of clinical studies throughout
duration of study.
* Adheres to regulatory requirements of study conduct and industry
standards of Good Clinical Practice as well as Gilead SOPs.
* Prepares study protocols, amendments, specific sections of study
manuals and Investigator meeting notebooks, and other documents as
needed.
* Supervises or assists other CR staff with preparation of above.
Contributes to the design and development of CRFs, Data Management
Manuals and Data Analysis Plans.
* Helps ensure consistency across protocols.
* Presents scientific information if needed.
* Addresses questions regarding scientific and related procedural
issues from Investigators.
* Coordinates and implements ongoing data for internal analysis and
review.
* Coordinates/supports the preparation/review of regulatory
documents, PIPs/PSPs, safety reports, Investigator Brochures, and
NDAs.
* Determines the functions most critical to company success and
supports priorities within functional area.
* Anticipates fairly complex obstacles and implements solutions that
meet goals.
* Creates effective teams with a clear sense of direction.
* May lead two or more specific components of departmental strategic
initiatives.

KNOWLEDGE, EXPERIENCE & SKILLS:

ESSENTIAL:

* Typically requires a higher degree MD, with significant years in
clinical research or clinical pharmacology in a pharmaceutical
company, contract research organization or academic institution
* Experience in pediatric medicine and/or pediatric drug development
will be highly desirable but not required
* 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.
* Examines functional issues from a broader organization
perspective.
* Knowledge of clinical trial design to develop specific study
concept sheets and protocols is required.

DESIRABLE SKILLS:

* Familiarity with virology and HIV medicine preferred
* Clinical or translational research experience preferred
* Pharmaceutical/Biotech industry experience in clinical development
preferred
* Successful leadership and management experience
* Excellent organizational and communication skills are critical

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and
affiliates (collectively "Gilead" or the "Company") to recruit select
and employ the most qualified persons available for positions
throughout the Company. ?Except if otherwise provided by applicable
law, all ?employment actions relating to issues such as compensation,
benefits, transfers, layoffs, returns from layoffs, company-sponsored
training, education assistance, social and recreational programs are
administered on a non-discriminatory basis (i.e. without regard to
protected characteristics or prohibited grounds, which may include an
individual?s gender, race, color, national origin, ancestry,
religion, creed, physical or mental disability, marital status, sexual
orientation, medical condition, veteran status, and age, unless such
protection is prohibited by federal, state, municipal, provincial,
local or other applicable laws). ?Gilead also prohibits
discrimination based on any other characteristics protected by
applicable laws.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

_THIS EMPLOYER IS A CORPORATE MEMBER OF MYGWORK, THE BUSINESS
COMMUNITY FOR LGBTQ+ PROFESSIONALS, GRADUATES, INCLUSIVE EMPLOYERS &
ANYONE WHO BELIEVES IN WORKPLACE EQUALITY._
Gilead Sciences is continuing to hire for all open roles. Our
interview process may be conducted virtually and some roles will be
asked to temporarily work from home. Over the coming weeks and months,
we will be implementing a phased approach to bringing employees back
to site to ensure the health and safety of our teams.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.
Job Description

The Sr Director MD, Clinical Research, position will design, conduct,
and evaluate Phase 1, 2, and 3 clinical trials and provide scientific
expertise on pediatric viral infectious diseases.

ESSENTIAL FUNCTIONS:

* Interfaces with staff to share scientific and clinical information
and consistent practices.
* Leads/supports protocol review discussions concerning scientific
and procedural aspects of study design.
* Serves as resource for junior staff.
* Oversees the scientific aspects of clinical studies throughout
duration of study.
* Adheres to regulatory requirements of study conduct and industry
standards of Good Clinical Practice as well as Gilead SOPs.
* Prepares study protocols, amendments, specific sections of study
manuals and Investigator meeting notebooks, and other documents as
needed.
* Supervises or assists other CR staff with preparation of above.
Contributes to the design and development of CRFs, Data Management
Manuals and Data Analysis Plans.
* Helps ensure consistency across protocols.
* Presents scientific information if needed.
* Addresses questions regarding scientific and related procedural
issues from Investigators.
* Coordinates and implements ongoing data for internal analysis and
review.
* Coordinates/supports the preparation/review of regulatory
documents, PIPs/PSPs, safety reports, Investigator Brochures, and
NDAs.
* Determines the functions most critical to company success and
supports priorities within functional area.
* Anticipates fairly complex obstacles and implements solutions that
meet goals.
* Creates effective teams with a clear sense of direction.
* May lead two or more specific components of departmental strategic
initiatives.

KNOWLEDGE, EXPERIENCE & SKILLS:

ESSENTIAL:

* Typically requires a higher degree MD, with significant years in
clinical research or clinical pharmacology in a pharmaceutical
company, contract research organization or academic institution
* Experience in pediatric medicine and/or pediatric drug development
will be highly desirable but not required
* 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.
* Examines functional issues from a broader organization
perspective.
* Knowledge of clinical trial design to develop specific study
concept sheets and protocols is required.

DESIRABLE SKILLS:

* Familiarity with virology and HIV medicine preferred
* Clinical or translational research experience preferred
* Pharmaceutical/Biotech industry experience in clinical development
preferred
* Successful leadership and management experience
* Excellent organizational and communication skills are critical

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and
affiliates (collectively "Gilead" or the "Company") to recruit select
and employ the most qualified persons available for positions
throughout the Company. ?Except if otherwise provided by applicable
law, all ?employment actions relating to issues such as compensation,
benefits, transfers, layoffs, returns from layoffs, company-sponsored
training, education assistance, social and recreational programs are
administered on a non-discriminatory basis (i.e. without regard to
protected characteristics or prohibited grounds, which may include an
individual?s gender, race, color, national origin, ancestry,
religion, creed, physical or mental disability, marital status, sexual
orientation, medical condition, veteran status, and age, unless such
protection is prohibited by federal, state, municipal, provincial,
local or other applicable laws). ?Gilead also prohibits
discrimination based on any other characteristics protected by
applicable laws.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

_THIS EMPLOYER IS A CORPORATE MEMBER OF MYGWORK, THE BUSINESS
COMMUNITY FOR LGBTQ+ PROFESSIONALS, GRADUATES, INCLUSIVE EMPLOYERS &
ANYONE WHO BELIEVES IN WORKPLACE EQUALITY._


We need : English (Good)

Type: Permanent
Payment:
Category: Others

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