Posted:
5/30/2024, 5:00:00 PM
Location(s):
England, United Kingdom ⋅ Cambridge, England, United Kingdom
Experience Level(s):
Expert or higher ⋅ Senior
Field(s):
Legal & Compliance
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At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
As a Director, Global Regulatory Affairs, Precision Medicine you will develop and execute Precision Medicine regulatory strategies in alignment with the drug global regulatory strategy in collaboration with cross functional stakeholders across the Gilead therapeutic areas and in compliance with the appropriate regulations. You will need to work closely with the Vice President, Global Regulatory Affairs Oncology and Precision Medicine, and collaborate with the biomarker team and global/regional regulatory liaisons to provide Precision Medicine global regulatory guidance. You will provide regulatory strategy and support, ensuring communication of a clear vision for the translational discovery, development, and validation of biomarkers in clinical studies. You will provide operational and technical regulatory assistance through all stages of clinical development through global registration for IVD projects. In addition, you may be involved in the identification of predictive biomarkers that may influence drug product’s clinical development strategy and proof of mechanism.
EXAMPLE RESPONSIBILITIES:
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.
Education & Experience
BA/ BS or advanced degree in life sciences or related field with significant regulatory experience in the biopharma industry, regulatory agency, clinical research or other related healthcare environment. Experience in in vitro diagnostic development strongly preferred
Knowledge & Other Requirements
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.
Please log onto your Internal Career Site to apply for this job.
Website: https://gilead.com/
Headquarter Location: Seoul, Seoul-t'ukpyolsi, South Korea
Employee Count: 51-100
Year Founded: 2011
IPO Status: Private
Industries: Health Care ⋅ Marketing ⋅ Medical ⋅ Pharmaceutical