Head of Legal and Business Operations

3 weeks ago


New York, New York, United States Volastra Therapeutics Full time
Duties and Responsibilities:
Our ideal candidate will have a minimum of 10 years of relevant legal experience, preferably both at a firm and at least one recent leadership role in-house for a biotechnology or pharmaceutical company. Key responsibilities include:
  • Oversight of standard legal matters, including intellectual property, corporate governance, contracts, employment law, and litigation.
  • Management of litigation and dispute resolution matters, including coordinating with external counsel, conducting investigations, and representing the company in legal proceedings as necessary.
  • Development and implementation of compliance programs to adhere to FDA, EMA, and other regulatory requirements related to clinical trials and eventual product commercialization.
  • Leadership and optimization of the company's operational functions, including IT, facilities management, and general corporate services.

Requirements:
To succeed in this role, you must have in-depth knowledge of FDA regulations, EMA guidelines, and other global regulatory requirements for clinical-stage and commercial-stage biotechnology companies. You should also be familiar with data privacy laws impacting clinical trial data and biospecimen handling, including state-specific data privacy laws, EEA GDPR, and UK GDPR. Additional qualifications include strong analytical and problem-solving skills, excellent communication and interpersonal skills, and the ability to analyze complex legal issues, identify creative solutions, and make sound recommendations to senior leadership.

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