Director, Safety Scientist

About the role

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. This role represents GPS Safety Science internally and externally at a global level and functions as an authoritative and professional member of relevant teams.

Responsibilities

• Signal and Safety Data Evaluation
  • Identify, analyze, and evaluate safety signals from multiple internal and external data sources.
  • Determine signals or risks that could result in changes to labels and/or benefit-risk profile.
  • Define data acquisition strategy, methodology, and approach for safety evaluations.
  • Analyze safety data and lead authoring of safety assessment.
  • Collaborate with PSLs, Safety Scientists, Pharmacoepidemiologists, and cross-functional personnel to ensure thorough evaluation and aggregate analysis of safety data.
  • Lead execution of signal assessment strategy and assess potential impact on the product safety profile with recommendation for action.
  • Initiate proposal for Safety Management Team.
• Execution of Safety Governance Meetings
  • Prepare and present safety data at safety governance meetings (Safety Management Team and Company Safety Committee).
  • Present safety data at Safety Monitoring Committee (SMC), Data Monitoring Committee (DMC)/Data and Safety Monitoring Board (DSMB).
• Communication and Influence
  • Communicate relevant safety information to core team, business partners, and key stakeholders in a timely manner.
  • Facilitate safety team meetings and drive decision making.
• Safety Communication Documents
  • Develop, update, and review safety communication documents (e.g., Dear Investigator Letter, Informed Consent Form, Investigator’s Brochure, Healthcare Professional communications (DHCP letter or DHPC), Labelling documents, Risk Management Plan, etc.) in collaboration with Safety Science team members and relevant cross-functional team members.
• Risk Assessment, Regulatory Inquiries, and Periodic Reporting
  • Lead analysis of safety data and author relevant safety sections of global regulatory inquiries and periodic reports including Development Safety Update Reports (DSURs), Periodic Adverse Drug. Experience Report (PADER)/ Periodic Adverse Experience Report (PAER), Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and Risk Management Plans (RMPs).
  • Lead and demonstrate ability to resource, plan, and fulfill additional evaluation requests with quality from health authorities (e.g., PRAC PSUSA).
  • Identify safety related questions from the review of inquiries and assess the impact to applicable safety documents or safety section of clinical or regulatory documents.
  • Lead strategy development, analysis, and response to safety questions from health authorities, IRBs/ECs.
  • Author Health Hazard Evaluations.
• Support Clinical Trials
  • Review safety data and monitor the safety of patients on allocated clinical trials.
  • Write and review safety sections and provide safety expertise for development of Protocols, IBs, ICFs, SAPs, TFLs, Medical Monitoring Plans, CSRs (incl. China ADR Summary), and other relevant project/study documents and answer ad-hoc safety queries from ethics committees.
  • Author safety sections of regulatory submissions, e.g., IND/CTA (General Investigational Plans, China Risk Control Plans), NDA/MAA (SCS/ISS, RMPs, initial Package Inserts).
  • Lead the authoring of Storyboards and Briefing Books for HA interactions.
  • Support ad-hoc review of the Safety Management Plans.
  • Lead Safety Science specific investigator training.
• Supervisory Responsibilities
  • Provide key support as an experienced safety scientist that leads and performs high quality and timely scientific, operational, and applicable medical safety analysis.
  • Work 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.
  • Support assigned compounds and line manager.

Qualifications

• 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.
• Education Required: 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 and 6+ years of pharmaceutical/biotechnology industry experience in Safety Science, Clinical Development, or Clinical Research is preferred.

Benefits

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. Packages may vary by location due to differences in the cost of labor.

The recruiter can share more about the specific salary range for a preferred location during the hiring process.

Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan.

All Company 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.

The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.