Director of Drug Safety Job at Albion Rye Associates, New Jersey

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  • Albion Rye Associates
  • New Jersey

Job Description

Job Title: Director / Snr Director of Drug Safety

Company: Mid-Sized Biotechnology Company

Location: New Jersey On-site

 

Albion Rye Associates are delighted to be exclusively partnering with a dynamic and well-funded mid-sized biotechnology company. With a rich and diverse pipeline, this client is one of the most desirable within the Biotech world across the world to join.

 

We are seeking a Director of Drug Safety to play a pivotal role in ensuring the safety of our investigational and marketed products. Mandarin-speaking capabilities are highly desired to support our global operations, including collaborations in Asia.

 

Key Responsibilities:

  • Strategic Leadership:
  • Develop and implement comprehensive drug safety strategies across the company’s pipeline and marketed products.
  • Serve as the subject matter expert on safety and pharmacovigilance matters in cross-functional teams.
  • Safety Oversight:
  • Lead the collection, evaluation, and reporting of safety data to ensure compliance with global regulations (FDA, EMA, NMPA, etc.).
  • Oversee signal detection, risk assessment, and mitigation activities.
  • Regulatory and Compliance:
  • Ensure compliance with all applicable pharmacovigilance and drug safety regulations, including the preparation of regulatory safety submissions (DSURs, PSURs, RMPs, etc.).
  • Represent the company during interactions with regulatory authorities and external partners.
  • Team Leadership:
  • Build and mentor a high-performing drug safety team to support both development and post-marketing activities.
  • Foster a culture of collaboration and excellence in safety science.
  • Global Collaboration:
  • Partner with global stakeholders, including Asian collaborators, to ensure alignment on safety practices and communication.
  • Utilize Mandarin language skills to facilitate effective communication and understanding in international settings (if applicable).

 

Qualifications:

  • MD, PharmD, PhD, or equivalent advanced degree in a related field.
  • Minimum of 8-10 years of experience in drug safety/pharmacovigilance within the biotechnology or pharmaceutical industry.
  • Proven expertise in global safety regulations and guidelines (FDA, EMA, ICH, NMPA).
  • Strong leadership and strategic thinking capabilities.
  • Exceptional communication and presentation skills.
  • Mandarin fluency (preferred) to support global collaborations and regulatory submissions in Asia.

Job Tags

Permanent employment,

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