Vice President, Analytical Development

GILEAD; Foster City (CA); On-site; USD 200,000 - 300,000; Full time

Job summary

A leading company in biotechnology is seeking a Vice President of Analytical Development to provide strategic direction across product lifecycles. The ideal candidate will lead a large team, drive innovation, and ensure alignment with regulatory standards while fostering a collaborative environment. This role is pivotal in advancing Gilead's diverse portfolio of therapies and ensuring quality across all modalities.

Qualifications

• 20+ years of relevant experience in Analytical Development.
• Experience with small molecules, peptides, ADCs, and biologics.
• Recognized leader in the field with extensive external experience.

Responsibilities

• Provide leadership to a department of 200+ scientists.
• Set strategies for all modalities in line with Gilead's priorities.
• Oversee analytical method development and data integrity.

Skills

Leadership

Collaboration

Strategic Vision

Accountability

Business Acumen

Education

PhD in Chemistry

MS in Chemistry

BS in Chemistry

Tools

Lab Automation

Computer Validation

Data Governance

Job 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 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

The Vice President, Analytical Development will be responsible for providing strategic and technical direction across the entire product lifecycle, from early development to commercialization for all modalities. With Gilead’s diverse portfolio, including small molecules, peptides, and biologics, this leader will have the opportunity to identify synergies across modalities to efficiently support our full development portfolio and serve as a pioneer to develop a strategic vision to seamlessly bring small molecules and large molecules together. In addition, this role will ensure we are leveraging state of the art technology to support the diverse portfolio. This leader will directly report to the SVP of Technical Development and be a member of the Technical Development Leadership Team responsible for providing leadership and decisions for the development and commercialization strategies of all modalities.

Responsibilities:

• Provide leadership and direction to the Analytical Development organization, a department of 200+ scientists

• Set strategies and develop long-range plans for all modalities in line with Gilead strategic priorities to deliver on Gilead’s long-term ambitions

• Provide technical guidance and drive alignment of near-term deliverables and long-range plans with respect to analytical control strategies and regulatory strategies for drug substance and drug product quality attributes across all PDM (Pharmaceutical Development & Manufacturing) functions

• Oversee analytical method development and analytical characterization for all drug substances and drug products in R&D programs;

• Oversee data generation / data integrity,

• Lead analytical team leads for Gilead Development Team and Commercial PDM sub-teams

• Direct AD leads for all PDM project teams and all commercial project teams

• Serve as a key advisor for the review of relevant PDM project reviews

• Serve as a senior member of the Technical Development Leadership Team responsible for developing and establishing PDM development strategies

• Evaluate and implement new technologies to drive innovation in Analytical Development and testing

• Drive development and implementation of new systems to improve project execution and data management

• Lead collaborations with Gilead PDM functions such as Quality Assurance, CMC Regulatory Affairs, Manufacturing and Technical Operations, Product and Portfolio Management, Finance, and Supply Chain

• Ensure strong relationships with key stakeholder functions including Research, Clinical Development, Clinical Supply Management, and Program Strategy Teams by providing technical and strategic input as a key advisor

• Hire, mentor, and develop team members within the organization

• Support regulatory filings by guiding the draft, review, and approval of CMC sections; support associated agency interactions and product-related inspections

• Provide technical support to internal and external cGMP manufacturing operations

• Develop and manage department budget

Qualifications:

• Typically requires a PhD, MS, or BS in chemistry or related fields with 20+ years of relevant experience

• Must have CMC experience with a range of modalities, including small molecules, peptides, ADCs, and biologics – with 15+ years of relevant experience in biologics preferred

• Recognized as leader in the field of Analytical Development with extensive external experience with relevant multi-national scientific organizations, conferences, associations, and health authorities

• Sound knowledge of chemistry, analytical technologies, computerized systems, and data integrity

• Well-versed in FDA and ICH guidelines relating to registration, quality, and compliance concerning drug substance, drug product, and devices

• Well-versed in analytical control strategies

• Experience with analytical testing networks

• Strong business acumen, including business contracting expertise

• Working knowledge of lab automation, computer validation, data governance, data science, knowledge management, and data protection

• Proven ability to lead high performing teams

• Leadership qualities of the successful candidate include the following: collaboration, building and developing high performing teams, accountability, cross functional engagement and influence, program management, and strategic vision

People Leader Accountabilities

• Create Inclusion - knowing the business value of diverse teams, modelling inclusion and embedding the value of diversity in the way they manage their teams.

• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.

• Empower Teams - connect the team to the organization by aligning goals, purpose, organizational objectives and holding to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

Gilead Core Values

• Integrity (Doing What’s Right)

• Inclusion (Encouraging Diversity)

• Teamwork (Working Together)

• Excellence (Being Your Best)

• Accountability (Taking Personal Responsibility)

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