Director of Drug Safety - Newark

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.