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AlphaLife Sciences

AI-driven clinical development and regulatory writing

Director of Security & Compliance

Security Governance, Risk & ComplianceUpdated on Nov 5
Full-timeJersey City, NJ, USA$180k - $250k /yrHybrid

About the Job

Requirements

  • A Bachelor's or Master's degree in Computer Science, Cybersecurity, Information Systems, or a related field is required.
  • At least 10 years of experience in cybersecurity, information security, or security compliance, including experience building or leading a security program.
  • A strong technical foundation in cloud security, application security, and threat detection and response is required.
  • Experience protecting sensitive data in life sciences, pharma, biotech, or another highly regulated industry is required.
  • Experience understanding intellectual property and its value, including safeguarding proprietary scientific or commercial information, is required.
  • Working knowledge of international data protection and security regulations, such as GDPR, PIPL, and US federal and state frameworks, and cross-border data transfer requirements is required.
  • Deep familiarity with life science data protection and regulatory compliance policy, including HIPAA and GxP, and frameworks such as ISO 27001 and SOC 2, is required.
  • Experience working with outside legal counsel to draft and implement policy is required.
  • Applicants must be authorized to work in the United States without current or future visa sponsorship.

Responsibilities

  • Protect the organization from external and internal security threats across its platform, infrastructure, and corporate systems.
  • Assess risks, determine credible threats, prioritize them, and lead the response.
  • Build and formalize the company's security policies, standards, and procedures from the ground up.
  • Partner with US and international law firms to draft, implement, and enforce policies that meet legal and regulatory standards.
  • Safeguard sensitive scientific, clinical, and commercial data, with a focus on protecting the company's and its clients' intellectual property.
  • Monitor international data and security regulations and advise leadership on cross-border data sharing and geopolitical risk in key markets.
  • Represent the company at industry conferences and serve as the primary security point of contact for pharmaceutical clients, law firms, and other partners, including security reviews and due diligence.
  • Own compliance certifications and framework alignment, including ISO 27001 and SOC 2, and keep the platform and processes aligned with GxP and HIPAA requirements.

Desired Qualifications

  • Certifications such as CISSP, CISM, CISA, or CCSP are desirable.
  • Experience leading SOC 2 or ISO 27001 efforts at a startup or growth-stage company is desirable.
  • Hands-on experience with 21 CFR Part 11 and computer system validation is desirable.
  • Experience operating in or alongside the China market is desirable.
  • IT and security leadership or data protection experience at a big pharma company, or regulatory policy leadership at a life science SaaS company, is desirable.
  • Background securing AI/ML or Generative AI platforms is desirable.

About the Company

AlphaLife Sciences

AI-driven clinical development and regulatory writing

AlphaLife Sciences automates medical writing and regulatory documentation for clinical development using its AuroraPrime platform, which generates and organizes regulatory content with Agentic AI. The system streamlines creation of clinical development documents and submissions across multiple therapies. Its differentiators include strategic partnerships with Microsoft, Johnson & Johnson Innovation JLABS, Google for Startups, Nvidia Inception, and Veeva’s AI Program, plus a focused capability for automated regulatory writing across therapeutic areas. The goal is to speed drug development and regulatory submissions so patients can access therapies sooner.

Company size
11-50
Company stage
Not listed
Total funding
Not listed
Headquarters
Singapore, Singapore
Founded
2020

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