Head of Commercial Development

Senior Director-Biologics Analytical Development (Pivotal and Commercial) United States - California - Foster City
Process/Product Development & Operations Regular
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.
Join Gilead and help create possible, together.
Senior Director in Biologics Analytical Development (Pivotal and Commercial) Foster City, CA
The Senior Director in Biologics Analytical Development (Pivotal and Commercial) will be responsible for leading analytical development activities encompassing physicochemical method development and qualification, testing of process related impurities, and the establishment of analytical testing strategies for drug substance and drug product. Additionally, they will be accountable for ensuring that product quality targets and specifications are established based on robust patient-centric considerations throughout pivotal development. Through these activities they will play an instrumental role in ensuring successful regulatory filing strategies.
Provide leadership to a group of analytical development scientists
Oversee budgeting for capital equipment
Analytical Methods: Development, Technical Support to QC, validations, and transfers, life-cycle management
High throughput analytical testing for drug substance and drug product development
Guide the authoring, review and approval of CMC sections in regulatory filings, and support interactions with health agencies
Collaborate across Gilead Pharmaceutical Development & Manufacturing (PDM) and partner with Quality, Supply Chain, Manufacturing, CMC Regulatory Affairs, Clinical Development and Technical Development to ensure timely delivery and successful commercialization of the late-stage Biologics portfolio
Act as a key member of the Analytical Development leadership team to shape late-stage development strategies
Set organizational goals that align with broader objectives while balancing immediate and long-term priorities
Recruit, hire, and mentor talent to help cultivate a world class Biologics AD organization
S. with 15+ years in Analytical Chemistry or related fields of industrial experience in biologics analytical development with people leader accountabilities.
Extensive experience with analytical method development and control strategies of biologics products.
UHPLC, CE-SDS, iCIEF) commonly used for biologics analytical development
Expertise in the development/qualification of various assays, including for purity and process related impurities
Well versed in FDA and ICH guidelines relating to registration, quality, and compliance concerning drug substance and drug product.
Proven track record in drafting regulatory documentation at all stages, including IND, BLA, and PAS filings.
Demonstrated ability of building strong collaborations with other CMC functions.
Working knowledge of lab automation, computer validation, data governance, data science, knowledge management and data protection.
Leadership qualities of the successful candidate include the following: collaboration, building and developing high performing teams, accountability, cross functional engagement and influence, program management, strategic vision, executive presence. Ability to build high performing teams and to set clear and measurable goals for staff and prioritize projects and resources.
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. Empower Teams - connect the team to the organization by aligning goals, purpose, organizational objectives and holding to account. Inclusion (Encouraging Diversity)
Accountability (Taking Personal Responsibility)