Vice President, Analytical Development

Gilead Sciences; Foster City (CA); On-site; USD 200,000 - 350,000; Full time

Job summary

A leading biotechnology company, Gilead Sciences, is seeking a Vice President for Analytical Development in Foster City, California. The role involves providing strategic leadership across the product lifecycle, driving innovation in analytical methodologies, and managing a large team of scientists. Ideal candidates will possess extensive experience in CMC, with a proven track record in leading high-performing teams and a strong strategic vision.

Qualifications

• Typically requires a PhD, MS, or BS in chemistry or related fields with 20+ years of experience.
• Must have CMC experience with a range of modalities, including biologics.

Responsibilities

• Provide leadership and direction to the Analytical Development organization.
• Set strategies and develop plans for all modalities.
• Oversee analytical method development and data generation.

Skills

Leadership

Collaboration

Strategic Vision

Business Acumen

Education

PhD in Chemistry or related field

Job description

Vice President, Analytical Development

United States - California - Foster City Clinical Development & Clinical Operations Regular

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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Job Requisition ID R0045290

Full Time/Part Time Full-Time

Job Level Vice President

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