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Regulatory / Clinical Affairs Specialist

Employer
Gladstone Institutes
Location
San Francisco, CA
Start date
Dec 4, 2023

View more

Discipline
Clinical, Clinical Medicine, Clinical Research
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay

Job Details

Category:Science
Lab/Area:Weinberger Lab

Description:

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.

Qualifications:

  • Experience authoring, assembling, and submitting IND applications

  • BA/BS degree

  • 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.

Hiring Range:

$90K- $120K (DOE)


Additional Information:
  • Title and salary will be commensurate with education and experience.
  • Gladstone is an equal opportunity employer.

Company

Gladstone is an independent, nonprofit life science research organization located in the epicenter of biomedical and technological innovation in the San Francisco Bay Area. Gladstone has created a research model that disrupts how science is done, funds big ideas, and attracts the brightest minds. Gladstone Institutes leads the way for innovative research in the biomedical field. We always seek dedicated and talented individuals to join our team.

Scientists know that using a diversity of approaches is often the most efficient strategy for solving a problem. New and different perspectives engender the very innovation that Gladstone prizes. This is one of the many reasons why we value diversity at Gladstone—be that a diversity of race, culture, religion, mental or physical ability, heritage, age, gender, sexual orientation or other characteristics. Our employees hail from more than 30 countries around the globe and we seek to hire the best and brightest for our diverse team of scientists and administrators. Career opportunities are available in both our administrative offices and our research areas.

Our Benefits
Gladstone offers eligible employees—and their dependents—a comprehensive range of benefits, including health insurance, retirement savings, and professional development.

Highlights

  • Health and Retirement
    • A choice of medical plans, flexible spending account, and retirement account options that include employer contributions help you take care of your health and your future.
  • Time Away from Work
    • More than just vacation days, our paid and unpaid leave policies offer flexibility to help you confront different stages of life including maternity and paternity leave, as well as other types of family leave.
  • Professional Development
    • Gladstone encourages employees to seek the skills they need to remain at the forefront of their profession. By supporting professional development workshops and continuing education, Gladstone provides employees with the resources they need to evolve in their role and in their career.
  • Gladstone Cares
    • A specially selected suite of benefits to support you in and out of the workplace. Includes resources for dealing with the many stages of life to specific coverage for family planning, and back-up child or elder care coverage.
Company info
Website
Location
1650 Owens Street
San Francisco
California
94158
United States

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