Dr. Leor Weinberger, director of the Gladstone-UCSF Center for Cell and Viral Circuitry, seeks a highly motivated Regulatory / Clinical Affairs Specialist to manage regulatory affairs, author and assemble IND applications, and help manage FIH studies on new antiviral gene therapeutic candidates.
The successful candidate will work in a dynamic academic environment collaborating closely with industry partners and supporting a group of enthusiastic and high-performing scientists and clinicians across institutions. The position requires coordinating regulatory activities including manufacturing, toxicology, and clinical aspects of the studies. The candidate must be able to work with a prolific, high-energy team in a fast-paced environment and will participate in regulatory strategy and execution. This position requires a high degree of confidentiality and is charged with handling and relaying sensitive information and findings.
Tasks include but are not limited to:
Author, assemble, and submit IND applications to FDA
Coordinating preparation of GMP, toxicology, and clinical sections as part of a collaborative multi-institutional project
Communicating with multiple entities effectively and often to meet project short-term and long-term goals
Coordinating with Gladstone Intellectual Property Department the execution of MTAs, patent filings, sponsored research and service agreements.
Assisting with preparation of study reports and presentations
Attending regular scientific collaboration meetings to stay abreast of research activities
Assisting PI with regulatory and clinical budgets and subcontract preparation
Coordinating with administrative and research assistants and managers to coordinate operations.
Experience authoring, assembling, and submitting IND applications
2+ years of experience in regulatory or clinical affairs
Ability to thrive in a fast-paced research environment and highly skilled in multitasking, time management, delegation, and prioritization.
Writing experience is required; examples to demonstrate successful writing preferred.
Ability to multitask and quickly prioritize work assignments
Ability to research, write and manipulate data through knowledgeable use of online technologies.
Ability to communicate effectively with information sources and colleagues in a professional and affable manner.
Ability to work across teams and with a variety of projects and constituencies.
Commitment to a professional culture that promotes diversity, safety, and environmental consciousness and that is conducive to effective relationships among diverse groups of employees.
Ability to problem-solve and analyze issues without precedent.
Knowledge of a variety of administrative operational activities.
$90K- $120K (DOE)Additional Information:
- Title and salary will be commensurate with education and experience.
- Gladstone is an equal opportunity employer.