Gileadhot
Sr Director, Analytical Development
United States - California - Foster City · Director
Sponsorship not specified$243k-$315kDetected 6 hours ago
Product ManagementPerformance ManagementGMPFDA RegulatoryResearchMass SpectrometryLeadershipCommunicationCollaborationMentoringRegulatory Affairs
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About the role
- Director of Analytical Development (AD) provides strategic and technical leadership for analytical development across the pipeline, from discovery through marketing approval and product lifecycle management.
Responsibilities
- Lead and develop an organization, from Directors to Research Associates, accountable for designing and executing science‑based, phase‑appropriate analytical strategies spanning raw materials through drug product to advance pipeline programs in alignment with clinical development plans, business objectives, and regulatory expectations.
- Lead strategic efforts to develop and continuously enhance analytical methods and technologies, translating innovation into robust, scalable commercial testing platforms.
- Partner with the Advanced Analytical Technology subfunction to define and execute the AD technology roadmap and drive phase‑appropriate deployment of innovative technologies that modernize control strategies, accelerate development, improve quality, and enable next‑generation manufacturing and analytical testing.
- Establish and maintain project plans, timelines, budgets, and resource/capacity plans
- manage headcount assignments by program and proactively identify/escalate delivery risks.
- Lead and develop a diverse organization of scientists and leaders through hiring, coaching, performance management, succession planning, and talent development.
- build strong alliances with Drug Substance, Drug Product, Regulatory, Quality, Manufacturing, and external partners/CMOs/CTLs.
- Establish and maintain project plans, timelines, budgets, and resource/capacity plans; manage headcount assignments by program and proactively identify/escalate delivery risks.
- Represent the function in cross-functional governance and leadership forums; build strong alliances with Drug Substance, Drug Product, Regulatory, Quality, Manufacturing, and external partners/CMOs/CTLs.
- Lead cross-functional teams and influence peers and senior management; effectively lead both with and without formal authority.
Requirements
- 12+ years with a graduate degree (either MS or PhD) or 14+ years with a BA/BS.
- Expertise in pharmaceutical/biopharmaceutical analytical development/product characterization.
- Demonstrated senior leadership experience leading highly technical organizations, with a track record of delivering through others.
- Deep expertise in phase-appropriate control strategy development and analytical method development and transfer to Quality organizations.
- Working knowledge of cGMP, data integrity expectations, and global regulatory requirements, with experience supporting successful US and international regulatory filings.
- Strong communication and presentation skills with the ability to distill complex technical content for diverse audiences.
- Ph.D. in Chemistry, Analytical Chemistry, Chemical Engineering, Biochemistry, or a related scientific discipline
- 12+ years with a graduate degree (either MS or PhD) or 14+ years with a BA/BS. Expertise in pharmaceutical/biopharmaceutical analytical development/product characterization.
- Small molecule analytical development across the lifecycle (discovery through commercial), including chromatography (HPLC/UPLC), mass spectrometry, impurity methods, stability, comparability, method validation, and test transfer.
- Proven ability to craft technical and innovation strategies and implement new methodologies to improve capability, robustness, and productivity.
- Demonstrated capability to solve complex quality, regulatory, and scientific problems under aggressive timelines.
- The salary range for this position is: $243,100.00 - $314,600.00. 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:
- https://www.gilead.com/careers/compensation-benefits-and-wellbeing
- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
- For jobs in the United States:
Compensation
- $243,100.00 - $314,600.00.
- 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*.
- 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.
- Manage Module 3 analytical content and data packages in collaboration with CMC Regulatory Affairs for IND/CTA, NDA/MAA/BLA and lifecycle submissions, including responses to health authority questions.
Company info
- At Gilead, we're creating a healthier world for all people.
- 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.
- 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.
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This listing is sourced directly from Gileadhot's careers page and normalized into a canonical job model.