Director, Clinical Development (MD)-Oncology Early Development
Company: Gilead Sciences, Inc.
Location: San Mateo
Posted on: January 24, 2023
Director, Clinical Development (MD)-Oncology Early
DevelopmentUnited States - California - Foster CityGilead Sciences,
Inc. is a research-based bio-pharmaceutical company that discovers,
develops and commercializes innovative medicines in areas of unmet
medical need. With each new discovery and investigational drug
candidate, we seek to improve the care of patients living with
life-threatening diseases around the world. Gilead's therapeutic
areas of focus include HIV/AIDS, liver diseases, cancer and
inflammation, and serious respiratory and cardiovascular
conditions.Making an impact on a global scaleInclusion is one of
the company's five core values. That's because we know that we are
stronger and more innovative at Gilead when we are informed by a
diverse set of backgrounds, experiences and points of view. 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. When
you join Gilead, you join our mission to change the world by
enabling people to live healthier and more fulfilling lives. Come
join a mission-driven bio-pharmaceutical organization that values
inclusion and diversity, has a strong portfolio of products, and is
constantly For Current Gilead Employees and Contractors:Please log
onto your Internal Career Site to apply for this job.Job
DescriptionPOSITION OVERVIEW: You will typically lead multiple
components of clinical trial programs in Oncology clinical
development. You may also act as the Physician responsible on
certain projects. For the assigned projects, you are accountable or
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
- Provides input into or leads the development of the Target
Product Profile and Clinical Development Plan for assigned
- 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
- 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
- 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 &
- MD or equivalent with 4+ years' clinical, scientific and/or
drug development experience in the biopharma industry, healthcare,
consulting, academia or a related environment.
- Board certification in Oncology is preferred, including
familiarity with clinical solid tumor and/or hematologic
- Experience in the biopharma industry is preferred.
- Significant experience working on, with and leading
cross-functional project/program teams in life sciences,
healthcare, consulting or academia.
- Experience taking the lead on study concept and protocol
design, regulatory filings, clinical publications and
- Demonstrated excellence in complex project management and
effectively managing multiple clinical project deliverables and
priorities through matrix management and leadership.Knowledge &
- Proven analytical abilities as demonstrated through past
experience and/or academic research.
- Has core expertise in the assigned or related disease area, as
evidenced by ability to independently lead clinical development for
deliverables for one or more projects.
- Has thorough understanding of pharmaceutical regulatory
requirements and impact on development and execution of clinical
- Strong communication and organizational skills. Demonstrable
abilities to effectively communicate project direction and status
to varying organizational levels, including leadership teams,
executives and steering committees.
- When needed, ability to travel.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 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' poster. NOTICE:
EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND
MEDICAL LEAVE ACT PAY TRANSPARENCY NONDISCRIMINATION PROVISION 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 to apply for this job.
Keywords: Gilead Sciences, Inc., San Mateo , Director, Clinical Development (MD)-Oncology Early Development, Executive , San Mateo, California
Didn't find what you're looking for? Search again!