Sr. Director, Global Regulatory Affairs, Oncology

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
 

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. Headquartered in Foster City, California, Gilead has operations in North, South and Central America, Europe, Africa, Asia and Australia. Gilead makes it a priority to increase access to its medicines for people who can benefit from them, regardless of where they live or their economic status. 

POSITION OVERVIEW:

As a Sr. Director, Early Oncology Global Regulatory Affairs, you will develop and execute Oncology regulatory strategies in alignment with the global regulatory strategies in collaboration with Franchise Lead and cross functional stakeholders in compliance with the appropriate regulations. You will act as the Global or Regional Regulatory Lead on complex or multiple products, compounds, indications or projects in the assigned therapeutic area. You will typically be assigned a portfolio of products or projects in early Oncology to lead, manage and oversee simultaneously. You will define the regulatory strategy, plans and objectives for assigned products or projects. Though the role is primarily focused on early oncology assets, you may act as the Global Regulatory Lead for early-stage, late-stage, or other programs depending on business needs. You will lead Regulatory Submissions Teams or other Regulatory Project Teams and represent Global TA Regulatory on cross-functional core and sub-teams including Project Strategy Teams. You will oversee preparation and maintenance of regulatory submissions, regulatory labeling and packaging for assigned products or projects; guiding and advising other colleagues in the thorough and compliant completion of these activities. You will provide operational and technical regulatory assistance through all stages of clinical development through global registration, as needed. You will play a leadership role in ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities. You will also help develop the TA's Regulatory leadership pipeline through coaching and mentoring other Regulatory colleagues and regional leads. 

Location: Parsippany, NJ

FUNCTION: Global Therapeutic Area (TA) Regulatory Liaisons

RESPONSIBILITIES:

• Accountable for the successful oversight and completion of a broad spectrum of regulatory activities and deliverables for products, compounds, indications and/or other projects in the oncology therapeutic area.  

• As needed, represents Gilead in negotiations with regulatory authorities. Oversees contacts for local regulatory authorities. 

• Works on extremely complex problems and provides solutions that have significant impact. 

• Makes significant contributions to the ongoing development and refinement of regulatory strategies, processes, standards, practices, efficiencies and capabilities.  

• Represents Regulatory Affairs and may serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory Submission Teams and Project Strategy Teams. Provides strategic advice and guidance to Regulatory Affairs and cross-functional leaders and teams.  

• Advises other functions on short- and long-range regulatory strategies, plans, resources and tactics as the global regulatory representative in cross functional meetings such as the program strategy team and global development team.