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Associate General Counsel, Regulatory & Technology

Confidential

Indianapolis, IN

Associate General Counsel, Regulatory & Technology

About the Company

AI-enabled precision oncology biotech firm

Industry
Biotechnology

Type
Privately Held, VC-backed

Founded
2022

Employees
11-50

Funding
$200+ million

Specialties

  • ai
  • biotechnology
  • drug development
  • oncology
  • precision medicine
  • cancer biology
  • data science
  • machine learning
  • clinical trials
  • drug discovery
  • precision oncology
  • biopharma
  • pharma
  • and computational biology

About the Role

The Company is seeking an Associate General Counsel with a focus on Regulatory and Technology. This role is pivotal in the application of legal expertise to the development of innovative cancer treatment technologies. The successful candidate will serve as the primary legal advisor to the engineering, product, clinical, and operations teams, with a specific emphasis on regulatory matters including FDA drug development law, privacy, corporate compliance, and AI guidelines. Key responsibilities include advising on regulatory strategy, maintaining the company's compliance program, and engaging with regulatory bodies. The role demands a deep understanding of the technical stack to effectively represent it in legal and regulatory discussions, as well as the ability to learn and adapt to new technologies. Applicants must have a J.D. from a top law school, active bar admission, and at least 7 years of legal experience, with a significant portion in-house, preferably in a high-growth technology or biotech environment. Essential qualifications include expertise in drug development law, experience in advising engineering or product teams, and a proven track record of building regulatory strategy. The ideal candidate will be proactive, detail-oriented, and comfortable working in a fast-paced, ambiguous environment. Familiarity with clinical data standards, real-world evidence, and biomarker qualification is a plus, as is a background in AI-in-drug-development, precision medicine, or genomics. The role requires a candidate who can thrive in a dynamic, innovative setting and is adept at problem-solving and process development.

Hiring Manager Title
General Counsel

Functions

  • Legal
Confidential
Apply
Vacancy posted 3 days ago
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