Part-Time Faculty: Biotechnology Law, School of Law
Listed on 2026-01-02
-
IT/Tech
Data Scientist, Data Security
Part‑Time Faculty:
Biotechnology Law, School of Law
1 day ago – be among the first 25 applicants.
Fordham University:
Office of the Provost:
Law
Location:
Lincoln Center Campus
Open Date:
Mar 14, 2024
Salary Range: $2,000–$15,000 per semester (dependent on credits and experience)
DescriptionFordham 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 statutes, 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.
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.
- 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.
- 10% Class participation
- 40% Three problem sets
- 50% Final exam
Introduction to biotechnology and regulatory frameworks
- Overview of the biotechnology industry
- Regulatory agencies and their roles
- Key legal principles governing biotechnology
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
Clinical trials process
- Regulatory requirements for conducting clinical trials
- Informed consent and ethical considerations
- Data collection, monitoring, and reporting obligations
Good manufacturing practices (GMP)
- Ensuring product quality and safety in manufacturing
- Regulatory compliance and inspections
- GMP’s role in biotechnological product development
- New Drug Application (NDA) and Biologics License Application (BLA) processes
- Regulatory pathways for approval
- Expedited approval programs and breakthrough designations
Post‑approval marketing and safety
- Drug and device labeling requirements
- Post‑marketing surveillance and adverse event reporting
- Risk management plans and post‑approval…
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).