Job Description

Fordham Law School invites applications for an adjunct instructor position to teach a course on law and regulation in biotechnology. The expected start date is for the fall 2024 or spring 2025 semester. The Law School is particularly interested in courses that combine both theory and current legal practice.

Responsibilities:

• Teach an engaging course at the Law School exploring legal issues within biotechnology, including in-depth analysis of statues, regulations, case-law, and other practice-oriented documents as well as industry practices.
• Develop a syllabus that covers essential topics throughout the life cycle of biotechnological products, from early-stage research to clinical trials, approval, and post-approval marketing and safety.
• Shape a set of learning objectives that students will master by the end of the course.
• Evaluate and grade student course performance in alignment with the appropriate grading curves, providing constructive feedback to foster students’ understanding of core concepts.

R3. Law and Regulation in Biotechnology

Course Description

This course serves as an introduction to the intricate legal and regulatory landscape governing the biotechnology industry. Students will explore the various legal frameworks that shape the entire life cycle of biotechnological products, from early-stage research to post-approval marketing and safety. The course will delve into essential topics, including the clinical trials process, good manufacturing practices, FDA approval requirements, and regulations concerning generics and biosimilars. Additionally, the course will survey the legal considerations on the business and financing side of biotechnology, covering intellectual property, funding mechanisms for research, material transfer agreements, other contractual arrangements, and various corporate structures.

Learning Objectives

Comprehensive understanding of biotechnology principles: define and explain the fundamental principles and processes involved in biotechnology, including genetic engineering, molecular biology, and other key technologies.

Knowledge of regulatory agencies and legal frameworks: identify and describe the roles and responsibilities of regulatory agencies governing the biotechnology industry and analyze the legal frameworks that shape the development, approval, and marketing of biotechnological products.

Understand intellectual property, clinical trials, and FDA approval processes.

Apply legal principles to real-world scenarios and case studies.

Develop critical thinking and problem-solving skills in navigating complex legal issues in the biotechnology industry.

Evaluation

10% Class participation

40% Three problem sets

50% Final exam

Assignment Topics

Week 1: Introduction to biotechnology and regulatory frameworks

• of the biotechnology industry
• Regulatory agencies and their roles
• Key legal principles governing biotechnology

Week 2: Early-stage research and intellectual property

• Contractual considerations in early-stage research
• Regulatory considerations in early-stage research
• Protection of biotechnological inventions
• Patents, trade secrets and other forms of intellectual property
• Balancing innovation and disclosure

Week 3: Clinical trials process

• Regulatory requirements for conducting clinical trials
• Informed consent and ethical considerations
• Data collection, monitoring, and reporting obligations

Week 4: Good manufacturing practices (GMP)

• Ensuring product quality and safety in manufacturing
• Regulatory compliance and inspections
• GMP’s role in biotechnological product development

Week 5: FDA approval requirements

• New Drug Application (NDA) and Biologics License Application (BLA) processes
• Regulatory pathways for approval
• Expedited approval programs and breakthrough designations

Week 6: Post-approval marketing and safety

• Drug and device labeling requirements
• Post-marketing surveillance and adverse event reporting
• Risk management plans and post-approval commitments

Week 7: Generics and biosimilars

• Regulatory pathways for generic drugs and biosimilars
• Interchangeability and substitution considerations
• Legal challenges and market dynamics

Week 8: Business and financing in biotechnology

• Funding mechanisms for biotechnological research
• Material transfer agreements and other contractual agreements
• Corporate structures and governance in biotechnology companies

Week 9: Ethical and social implications

• Ethical considerations in biotechnological research and development
• Societal impact and public perception
• Legal responses to ethical challenges

Week 10: Emerging issues in biotechnology law

• CRISPR technology and gene editing
• Personalized medicine and regulatory challenges
• Global harmonization and international collaborations

Qualifications

· Juris Doctor degree with extensive expertise in biotechnology law.

· Prior teaching experience preferred.

The salary range for this job is $2,000-$15,000 per semester, dependent on the number of credits offered, experience and practice area.

We value diversity and strongly encourage individuals from a range of backgrounds to apply.

Fordham Law School is a national leader in the field, with approximately 1,600 students in our J.D., LL.M. and M.S.L. programs. Fordham is the Jesuit University of New York and serves students of all faiths, including those with no faith.

Application Instructions

Interested candidates should submit a cover letter, curriculum vitae, and a brief statement outlining their approach to teaching and the topic and goals of their proposed course(s) at this link (http://apply.interfolio.com/142931). For questions, please contact Audrey Glassman at aglassman@law.fordham.edu

Equal Employment Opportunity Statement

Fordham University is committed to excellence through diversity and welcomes candidates of all backgrounds.

Fordham University is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

Effective October 24, 2025, the University will not approve or move forward with any new faculty hires that require the filing of an H-1B petition who are foreign nationals residing outside the U.S. For all other aspects, we will continue to follow Fordham’s policy on Appointment of Nonimmigrant Faculty