Sr. Associate Clinical Development Director (Oncology)
Company: Gilead Sciences, Inc.
Location: San Mateo
Posted on: November 25, 2022
Sr. Associate Clinical Development Director (Oncology)United
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
- 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
- Provides ongoing clinical 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 &
- PharmD or PhD in clinical research or clinical pharmacology
with 5+ years' scientific and/or drug development experience in the
biopharma industry, healthcare, consulting, academia or a related
- MS with 9+ years' relevant scientific and/or drug development
- BS or RN with 11+ years' relevant scientific and/or drug
- Relevant experience in Oncology is preferred.
- Experience in the biopharma industry is preferred.
- 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
- 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
- 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.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 , Sr. Associate Clinical Development Director (Oncology), Healthcare , San Mateo, California
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