- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
-
Senior Engineering Director
5 days ago
BHO Tech San Mateo, United States Full timeSenior Director Engineering - Game Engine, Sa n Mateo, CA · WHY US? · Our imagination platform is ushering in the next generation of entertainment. We enable kids of all ages to imagine, create, and play together in immersive experiences on their phones, desktops, consoles, and ...
-
Senior Director, Scientific Publications
3 weeks ago
Gilead Sciences, Inc. Foster City, United States Full timeDescription · Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the w ...
-
Senior Director, Scientific Publications
1 week ago
Gilead Sciences Foster City, United States RegularJob Description · 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 therap ...
-
Senior Director, Clinical Operations
11 hours ago
Gilead Sciences Foster City, United States RegularJob Description · For Current Gilead Employees and Contractors: · Please log onto your to apply for this job. · 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 ...
-
Senior Director, Engineering
3 days ago
GEICO San Mateo, United States Full timeThis role is part of Enterprise Engineering. We are looking for a leader that has experience in productivity & collaboration toolset. Responsibilities include domain expertise with O365, audio, web conferencing, messaging tooling. The ideal candidate will have demonstrated track ...
-
Senior Director, Legal
1 week ago
Cellanome Job Board Foster City, United StatesWe are looking for a strong generalist with broad legal expertise to support multiple aspects of the company including commercial, operations, contracts, employment, licensing and collaborations. You will be responsible for developing effective legal strategies that contribute to ...
-
Senior Director, Medical Review
1 day ago
Gilead Sciences, Inc. Foster City, United States Full timeDescription · You will establish visions and objectives for the Medical Review (MR) group taking into consideration of the departmental short- and long-term goals, lead the MR group to deliver timely and high-quality medical review, ensure the MR process and procedure in alignme ...
-
Senior Director, Clinical Operations
3 days ago
Gilead Sciences, Inc. Foster City, United States Full timeDescription · The Clinical Operations Oncology Franchise Head reports into the Vice President, Oncology Clinical Operations and is a critical leadership role accountable for management of a large group of Clinical Operations professionals ( ͂ 50 FTEs) and people leaders across a ...
-
Senior Director Field Access
3 days ago
Dompé San Mateo, United StatesGeneral Job Description / Purpose: · Reporting to the VP of Market Access, the Senior Director ("Sr. Dir.") of Field Access and Reimbursement is the national lead for field based healthcare providers ("HCP") and patient facing access and reimbursement efforts within the Market A ...
-
Senior Director, Finance
2 days ago
Freshworks San Mateo, United StatesCompany Description · Freshworks makes it fast and easy for businesses to delight their customers and employees. We do this by taking a fresh approach to building and delivering software that is affordable, quick to implement, and designed for the end user. Headquartered in San ...
-
Senior Medical Director
3 weeks ago
Mirum Pharmaceuticals Inc Foster City, United StatesMISSION · Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases affecting children and adults. Propelled by our passion for patients and their families, we're focused on turning possibilities into realities. Using data and m ...
-
Senior Director, Legal
1 week ago
Cellanome Belmont, United StatesWe're a well-funded start-up. You'll get a chance to wear many hats, be a part of a growing team, and have the potential for exciting financial and career growth. · Here's what sets us apart. We've set our sights on some of the biggest challenges facing biology today. We're amas ...
-
Senior Director Engineering
1 week ago
Roblox San Mateo, United StatesEvery day, tens of millions of people come to Roblox to explore, create, play, learn, and connect with friends in 3D immersive digital experiences– all created by our global community of developers and creators. · At Roblox, we're building the tools and platform that empower our ...
-
Senior Director, Legal
2 days ago
Cellanome San Mateo, United StatesWere a well-funded start-up . Youll get a chance to wear many hats, be a part of a growing team, and have the potential for exciting financial and career growth. · Heres what sets us apart. · Weve set our sights on some of the biggest challenges facing biology today. Were amass ...
-
Senior Director, Legal
1 week ago
Cellanome Job Board San Mateo, United StatesWe're a well-funded start-up. You'll get a chance to wear many hats, be a part of a growing team, and have the potential for exciting financial and career growth. · Here's what sets us apart. We've set our sights on some of the biggest challenges facing biology today. We're amas ...
-
Senior Medical Director
3 weeks ago
Iovance Biotherapeutics Inc San Carlos, United StatesJob Description · Job DescriptionSalary: $305,000 - $337,000 · Overview · The Senior Medical Director is primarily responsible for overseeing the direction, planning, execution, and interpretation of clinical trials and the data collection. · Essential Functions and Responsibili ...
-
Senior Director
1 day ago
Gilead Sciences, Inc. Foster City, United States Full timeSenior Director - Analytical Regulatory Science · United States - California - Foster City · Gilead 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 discove ...
-
Senior Director, Medical Review
4 days ago
Gilead Sciences Foster City, United StatesJob Description · 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 therap ...
-
Senior Medical Director
3 weeks ago
Iovance Biotherapeutics Inc. San Carlos, United StatesOverview · The Senior Medical Director is primarily responsible for overseeing the direction, planning, execution, and interpretation of clinical trials and the data collection. · Essential Functions and Responsibilities · * Directs protocol implementation including site identifi ...
-
Gilead Sciences Foster City, United StatesSenior Director, Purification Process Development – Pivotal & Commercial Biologics · Senior Director, Purification Process Development – Pivotal & Commercial Biologics · United States - California - Foster City · Process/Product Development & Operations · Regular · Job Descri ...
Senior Director - Foster City, United States - Gilead Sciences
![Default job background](https://contents.bebee.com/public/img/bg-user-ex-1.jpg)
Description
Senior Director - Analytical Regulatory Science page is loadedSenior Director - Analytical Regulatory Science
Bewerben
locations
United States - California - Foster City
time type
Full time
posted on
Vor mehr als 30 Tagen ausgeschrieben
job requisition id
R
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site
to apply for this job.
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.
We empower our leaders to step up, share ideas, listen, learn, and lead.We're welcoming bright, diverse, and imaginative minds; we're nurturing them to foster an environment of inclusion and growth where innovation is encouraged.
We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.
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.
Join Gilead and help create possible, together.Job Description
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.Senior Director - Analytical Regulatory Science
KEY RESPONSIBILITIES
The Sr Director, Analytical Regulatory Science, is responsible for supervising a team of scientists, who collaborate with product development, manufacturing and quality teams on the construction, documentation and defense of the analytical control strategies in regulatory submissions preparation, review and approval.
By balancing analytical knowledge and evolving regulatory expectations with manufacturing and analytical flexibility the incumbent will support "right first time" global approvals for CMC control strategies and maintain "right to operate" throughout the product lifecycle.
In addition, the Sr Director will be accountable for leading the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure approvability globally.
The incumbent will report directly to Head of CMC Regulatory Affairs – Systems and Operations at Gilead.JOB DESCRIPTION
Drives and supervises team members to drive analytical control strategy development and justification in regulatory filings for projects throughout product lifecycle.
Guides project teams on preparation of analytical filing content, and participates in authoring and reviewing of complex submissions and responses to questions from health authorities.
Exercises expertise in the interpretation and implementation of ICH and regional guidelines with the goal of right first time approval of regulatory control strategies.
Evaluates and drives the implementation of new regulatory and quality requirements for analytical control strategy in partnership with technical and manufacturing teams.
Promotes continual improvement for analytical control strategies, quality compliance/business processes, and regulatory filing content taking into consideration internal experience and learning from the externalenvironment.
Ensures conformance to regulatory and quality requirements and internal procedures in the management of filing content and changes.
Evaluates and communicates risks for CMC control strategies and quality compliance to CMC RA and PDM leadership.
Develops meaningful and collaborative relationships with cross-functional teams and leaders across CMC RA and PDM.
Works with CMC RA Team Leads to provide one CMC RA voice to PDM project teams regarding regulatory strategy and technical and quality risks.
Demonstrates success in influencing without positional authority within a highly matrixed organization.Mentors and coaches team members to accelerate learning and professional development.
Demonstrates and models Gilead's Core Values, Leadership Commitments, and People Leader
Accountabilities.
May have cross-functional leadership roles, and may participate in business process development initiatives or represent the company in industry consortia.
QUALIFICATIONS
A scientific degree with directly relevant professional experience in analytical chemistry or chemistry, with at least 14 years with a BA/BS or 12 years with an MA/MS, PhD, or PharmD.
Demonstrated track record defining analytical control strategy approaches for products taking into consideration existing and emerging ICH and regional guidance.
Experience creating appropriate analytical control strategies attributes through product lifecycle.Experience with clinical, premarket and post market submissions preparation including resolution of complex regulatory questions while maintaining manufacturing and analytical flexibility.
Strong strategic thinking, decision making, prioritization skills, and communication skills (written and verbal) including experience presenting to senior leaders.Ability to influence cross-functionally to integrate regulatory and quality thinking and requirements into development plans and activities.
Experience leading or participating in cross-functional initiatives.
Experience leading or participating in cross-functional initiatives.
Demonstrated organizational leadership skills at a functional level.
Demonstrated commitment to creating inclusion, developing talent and empowering teams.
Gilead Core Values
Integrity (Doing What's Right)
Inclusion (Encouraging Diversity)
Teamwork (Working Together)
Excellence (Being Your Best)
Accountability (Taking Personal
Responsibility)
The salary range for this position is:
$237, $307, 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:
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.
for assistance.
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.
Ähnliche Stellen (5)
Senior Manager, Global Regulatory Operations Quality Review
locations
2 Standorte
time type
Full time
posted on
Vor 11 Tagen ausgeschrieben
Senior Director, Scientific Publications - Oncology
locations
United States - California - Foster City
time type
Full time
posted on
Vor mehr als 30 Tagen ausgeschrieben
Senior Director, RWE Innovation & External Partnerships
locations
3 Standorte
time type
Full time
posted on
Vor mehr als 30 Tagen ausgeschrieben
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.#J-18808-Ljbffr