[Hiring] Director, Safety Scientist @BeiGene

Role Description

The Director, Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages clinical and scientific expertise to lead the detection of safety signals, evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and regulatory-required periodic reporting. Physicians in this role are also expected to provide medical safety assessment. In this role, you will apply effective prioritization, critical thinking, and judgment-based decision making to execute these key deliverables in compliance with global regulations and internal processes. Effective communication and influence with internal and external stakeholders are important capabilities for this role. This role represents GPS Safety Science internally and externally at a global level and functions as an authoritative and professional member of relevant teams.

Qualifications

• PharmD, NP, RN, or PhD in a medical field or biological science and 8+ years of experience as a Safety (Pharmacovigilance) Scientist.
• MD (or internationally recognized equivalent) plus accredited residency or have completed a comparable level of post-medical school clinical training relevant to the country of hiring.
• 4+ years of clinical experience with patients in a relevant therapeutic area specialty, with significant knowledge of general medicine.
• 6+ years of pharmaceutical/biotechnology industry experience in Safety Science, Clinical Development, or Clinical Research is preferred.

Requirements

• Advanced knowledge working with a safety database (i.e., Argus) for retrieval of safety information.
• Advanced knowledge of MedDRA and signal management system.
• Advanced application capability with Excel, PowerPoint, Word, and electronic document management system (i.e., Veeva).
• Advanced knowledge of data mining tools and analyses tools such as Spotfire and PowerBI.
• Prior matrix management team experience.
• Clinical knowledge of various disease states, drug effects, human physiology and pharmacology.
• Demonstrated ability to prioritize and manage multiple deliverables simultaneously.
• Demonstrated leadership, organizational and administrative skills.
• Prior experience with Regulatory Agency interactions.
• Pharmaceutical product development experience, including individual study design and filing plans.
• Experienced in global regulatory requirements for pharmacovigilance.

Benefits

• Comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
• All employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan.
• Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan.

Supervisory Responsibilities

This position may have direct reports depending on the program/portfolio being led. The Director, Safety Scientist provides key support as an experienced safety scientist that leads and performs high quality and timely scientific, operational, and applicable medical safety analysis. This position works closely with the Safety Science group as part of a matrix team to conduct safety assessment and safety risk management activities per BeiGene process and applicable regulations and provides a high degree of support to assigned compounds and line manager.

Travel

Less than 10%

Global Competencies

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Salary Range

$185,100.00 - $245,100.00 annually. BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location.