Chief of Staff - R&D
Addepar$143,000 - $224,000/year
Full Time
Expert & Leadership (9+ years)
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, BiotechnologyIndustries
Requirements
- Strong leadership skills
- Expert drug development and GCP knowledge
- Advanced understanding of the application of Quality Risk Management principles
Responsibilities
- Design and implement an integrated Quality Operations Strategy for the Gilead R&D portfolio
- Establish standards, tools & performance indicators for key activities including quarterly metrics & risk reporting for Program/Study Quality Briefs, Due Diligence, Quality Oversight Plans, critical quality event management, serious breach assessment and reporting
- Lead the analysis and interpretation of key quality data in Program/Study Quality Briefs for the presentation and reporting to functional and executive leadership
- Lead and oversee lessons learned activities driving continuous improvement
- Optimize R&D Program Quality performance by implementing a flexible centralized resourcing model for high-demand activities
- Oversee and lead critical quality event investigations and serious breach assessments
- Act as point of contact (PoC) for due diligence activities ensuring collaboration with Regulatory and Safety leads
- Collaborate with Oncology, Virology and Inflammation Program Leads in assessing cross therapeutic area risks
- Act as PoC for Program Quality for key initiatives within Global R&D Quality and RSQ
- Provide guidance and training for core quality management capabilities such as risk management, quality event management and issue escalation, and deviation and CAPA management
- Establish strong partnership with key business stakeholders, including Clinical Development, Clinical Operations, Regulatory, Safety, and Clinical Data Science
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What is the salary or compensation for the Sr Director, R&D Quality role?
This information is not specified in the job description.
Is this Sr Director, R&D Quality position remote or does it require office work?
This information is not specified in the job description.
What skills are required for the Sr Director, R&D Quality role?
The role requires strong leadership skills, expert drug development and GCP knowledge, and advanced understanding of the application of Quality Risk Management principles.
What is the company culture like at Gilead for this role?
Gilead promotes a culture of collaboration, determination, and relentless drive to make a difference, with People Leaders driving an inclusive environment where employees feel developed and empowered. The R&D Quality team strives to be trusted business partners and promotes a culture of Quality in all they do.
What makes a strong candidate for the Sr Director, R&D Quality position?
Strong candidates will have strong leadership skills, expert knowledge in drug development and GCP, and advanced understanding of Quality Risk Management principles, enabling them to lead strategy and drive optimized performance in R&D Quality.
Gilead Sciences
Develops and commercializes biopharmaceuticals
About Gilead Sciences
Gilead Sciences focuses on discovering, developing, and commercializing medicines for various medical conditions, including HIV/AIDS, liver diseases, cancer, inflammatory and respiratory diseases, and cardiovascular issues. The company conducts extensive research and development to create new therapies, which are then marketed to healthcare providers, hospitals, and pharmacies after receiving regulatory approval. Gilead differentiates itself from competitors through its strong commitment to R&D and strategic partnerships, such as with SAP Ariba, to enhance its operations and product offerings. The company's goal is to improve health equity and access to care globally, working with communities to ensure that its medicines reach those in need.
Foster City, CaliforniaHeadquarters
1987Year Founded
$15,873.6MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees
Benefits
Paid family time off and paid parental time off
Generous 401(k) contribution matching
Comprehensive medical plans that cover both physical and mental healthcare
Global Wellbeing Reimbursement
Time Off
Global Volunteer Day
Giving Together Program
Employee Support Programs
Flexible Work Options
Risks
Increased competition in HIV treatment from ViiV Healthcare's expanding drug portfolio.
Regulatory scrutiny over drug pricing could impact Gilead's U.S. market operations.
Patent expirations, like Truvada's, lead to increased generic competition and revenue loss.
Differentiation
Gilead's lenacapavir is recognized as the 2024 Breakthrough of the Year for HIV care.
Partnerships with LEO Pharma and Tubulis enhance Gilead's focus on inflammatory and cancer therapies.
Gilead's commitment to health equity initiatives like COMPASS and HepConnect sets it apart.
Upsides
Gilead's strategic partnerships expand its reach in inflammatory and oncology drug markets.
Investment in digital health technologies enhances Gilead's R&D and patient engagement.
Focus on sustainability improves Gilead's operational efficiency and corporate reputation.
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