Senior Associate Clinical Development Director (MD) - Clinical Development IBD/Inflammation
Company: Gilead Sciences
Location: San Mateo
Posted on: May 27, 2023
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Job Description:
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site
(https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI-/cacheable-task/2997$2151.htmld#backheader=true)
to apply for this job.
At Gilead we believe every employee deserves a great leader. As a
people leader now or in the future, we expect that you will model
and create an environment of inclusion, be intentionally focused on
the hiring, development, growth and retention of talent, and
empower teams to align and achieve goals.
Job Description
POSITION OVERVIEW:
You will typically lead multiple components of clinical trial
programs in IBD/inflammation clinical development. You may also act
as the Physician Responsible on certain projects. For the assigned
projects, you are accountable for various aspects of ongoing
clinical trial program-related activities. These activities
include, but are not limited to, study protocol preparation,
additional study or investigator documentation, contributions to
data analysis plans, study reporting, and clinical development
inputs into regulatory documentation, publications and scientific
presentations.
EXAMPLE RESPONSIBILITIES:
Provides input into or leads the development of the Target Product
Profile and Clinical Development Plan for assigned molecules
/products.
Provides scientific and clinical guidance to cross-functional teams
and colleagues to meet clinical development project deliverables
and timelines.
Provides input into, or otherwise leads, clinical trial protocol
design, clinical study reports and health authority inquiries.
Provides ongoing medical monitoring for clinical trials, including
but not limited to assessment of eligibility criteria, toxicity
management, and drug safety surveillance.
Manages the clinical development component(s) in the
preparation/review of regulatory documents, investigator brochures
and development plans.
Coordinates the collection and assimilation of ongoing data for
internal analysis and review.
Coordinates and manages the preparation and/or review of data
listings, summary tables, study results and scientific
presentations.
Presents scientific information at scientific conferences as well
as clinical study investigator meetings.
Adheres to regulatory requirements of study conduct and industry
standards of Good Clinical Practice as well as Gilead SOPs.
REQUIREMENTS:
We are all different, yet we all use our unique contributions to
serve patients. Please see the following for the qualifications and
skills we seek for this role.
Minimum Education & Experience
MD or equivalent with 2+ years' clinical, scientific and/or drug
development experience in the biopharma industry, healthcare,
consulting, academia or a related environment.
Board certification in gastroenterology is preferred, including
familiarity with IBD management.
Experience in the biopharma industry is preferred but not
required.
Experience leading small cross-functional project teams in clinical
research or development.
Experience taking the lead on study concept and protocol design,
regulatory filings, clinical publications and presentations is
preferred.
Proven effectiveness managing clinical project deliverables through
matrix management.
Knowledge & Other Requirements
Demonstrated ability to be a fast learner.
Demonstrated ability to be flexible and adaptable to change, to
move between projects easily and provide support/expertise where
needed.
Proven analytical abilities as demonstrated through past experience
and/or academic research.
Understands drug development phases and the nature of associated
clinical trials across phases.
Knowledge of FDA and EMA regulations, ICH guidelines, GCP and
familiarity with standard clinical procedures.
Has advanced knowledge of R&D and major disease areas, as
evidenced by effectiveness supporting clinical projects.
Strong communication and organizational skills.
When needed, ability to travel.
The salary range for this position is: $230,860.00 - $298,760.00.
Gilead considers a variety of factors when determining base
compensation, including experience, qualifications, and geographic
location. These considerations mean actual compensation will vary.
This position may also be eligible for a discretionary annual
bonus, discretionary stock-based long-term incentives (eligibility
may vary based on role), paid time off, and a benefits package.
Benefits include company-sponsored medical, dental, vision, and
life insurance plans*.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed
to a diverse workforce. Employment decisions regarding recruitment
and selection will be made without discrimination based on race,
color, religion, national origin, gender, age, sexual orientation,
physical or mental disability, genetic information or
characteristic, gender identity and expression, veteran status, or
other non-job related characteristics or other prohibited grounds
specified in applicable federal, state and local laws. 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.
Following extensive monitoring, research, consideration of business
implications and advice from internal and external experts, Gilead
has made the decision to require all U.S., Canada, Australia,
Singapore, and Hong Kong employees and contractors to receive the
COVID-19 vaccines as a condition of employment. "Full vaccination"
is defined as two weeks after both doses of a two-dose vaccine or
two weeks since a single-dose vaccine has been administered. Anyone
unable to be vaccinated, either because of a sincerely held
religious belief or a medical condition or disability that prevents
them from being vaccinated, can request a reasonable
accommodation.---
For more information about equal employment opportunity
protections, please view the 'Know Your Rights'
(https://www.eeoc.gov/employers/eeo-law-poster) poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
(http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf)
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
(https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf)
Our environment respects individual differences and recognizes each
employee as an integral member of our company. Our workforce
reflects these values and celebrates the individuals who make up
our growing team.
Gilead provides a work environment free of harassment and
prohibited conduct. We promote and support individual differences
and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site
(https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI-/cacheable-task/2997$2151.htmld#backheader=true)
to apply for this job.
Gilead Sciences, Inc. is a biopharmaceutical company that has
pursued and achieved breakthroughs in medicine for more than three
decades, with the goal of creating a healthier world for all
people. The company is committed to advancing innovative medicines
to prevent and treat life-threatening diseases, including HIV,
viral hepatitis and cancer. Gilead operates in more than 35
countries worldwide, with headquarters in Foster City,
California.
Following extensive monitoring, research, consideration of business
implications and advice from internal and external experts, Gilead
has made the decision to require all Canada, Australia, Singapore,
and Hong Kong employees and contractors to be fully vaccinated
against COVID-19 as a condition of employment. T he health of our
employees, contractors, their loved ones, our partners and the
communities and people we serve is a top priority. Vaccination is
the most effective way currently available to deliver on that
priority.
The purpose of the vaccination requirement is to minimize the
spread of COVID-19 in the workplace and support the health and
safety of our communities. A person is considered fully vaccinated
two weeks after the second dose of a two-dose vaccine or two weeks
after a single-dose vaccine has been administered. Anyone unable to
be vaccinated, either because of a sincerely held religious belief
or a medical condition or disability that prevents them from being
vaccinated, can request an accommodation.
Keywords: Gilead Sciences, San Mateo , Senior Associate Clinical Development Director (MD) - Clinical Development IBD/Inflammation, Executive , San Mateo, California
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