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Associate Director, Safety Scientist
3 months ago
**Company Overview:**
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) is a global, commercial-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. With a team of over 7,700 employees across China, the United States (Cambridge, MA; Ridgefield Park, NJ; Emeryville, CA & San Mateo, CA), Switzerland, Australia and Brazil, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for the treatment of cancer. BeiGene is working to create combination solutions aimed at having both a meaningful and lasting impact on cancer patients
**General Description:**
This role will focus on early development (phase I) and late stage (phase II-III) safety science activities. The position has no direct reports. The Associate Director Safety Scientist is part of a team that performs high quality and timely scientific and operational 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, based on ICH standards.
The person in this position provides safety expertise for assigned developmental and/or marketed products in conjunction with Product Safety Physician Leads (PSLs) and Safety Physicians. Represents GPS department internally and externally at a global level and functions as an authoritative and professional member of relevant teams. Leads signal evaluation/safety monitoring activities and contributes and assists in pharmacovigilance activities including benefit/risk and regulatory activities and interactions.
**Essential Functions of the Job:**
**Signal and Safety Data Evaluation**
+ Lead the identification, analysis, and evaluation of safety signals that arise from multiple internal and external data sources to determine signals or risks that could result in changes to labels and/or benefit-risk profile
+ Propose and lead data acquisition strategy, methodology, and approach for safety evaluations
+ Lead analysis of safety data and author safety assessment reports
+ Collaborate with PSLs, scientists, pharmacoepidemiologists, and other cross-functional personnel as appropriate to ensure thorough evaluation and aggregate analysis of safety data, demonstrating the ability to understand and communicate scientific issues and strategy
+ Execute signal assessment analysis per strategy and assist with the preparation of presentations for Safety Management Team and Company Safety Committee
+ Lead the preparation and presentation of safety data at safety governance meetings (Safety Management Team and Company Safety Committee) and for Safety Monitoring Committee (SMC), Data Monitoring Committee (DMC)/Data and Safety Monitoring Board (DSMB)
+ Apply judgment-based decision-making principles to contribute to key scientific/clinical discussions
+ Apply effective communication skills to lead and facilitate safety team meetings
+ Communicate relevant safety information to core team, business partners, and key stakeholders in a timely manner
+ Lead the development, update, and review of safety communication documents (e.g., Dear Investigator Letter, Informed Consent Form, Investigators 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
+ Perform signal detection and signal assessment along with required documentation following BeiGene process and applicable regulations.
**Clinical Trial Support**
+ Lead the review of safety data and monitor the safety of patients on allocated clinical trials
+ Lead the writing 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
+ Lead the authoring and review of safety sections of regulatory submissions, e.g., IND/CTA
+ (General Investigational Plans, China Risk Control Plans), NDA/MAA (SCS/ISS, RMPs, initial Package Inserts) collaborating with Safety Physicians and other CST members
+ Lead the authoring of Storyboards and Briefing Books for HA interactions
+ Lead with writing and maintenance of the Safety Management Plans
+ Lead Safety Science specific investigator training
**Risk Assessment, Regulatory Inquiries, and Periodic Reporting**
+ Lead the 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
**Promote and Advance the Field of Pharmacovigilance**
+ Any other tasks assigned by manager to assist in departmental activities
**Supervisory Responsibilities:**
+ The position has no direct reports. The Associate Director, Safety Scientist is part of a team that performs high quality and timely scientific and operational safety analysis. This position works closely with the Safety Scientist group as part of a matrix team to conduct safety assessment and safety risk management activities per BeiGene process and applicable regulations.
**Required Education:**
+ PharmD or PhD in a medical field or biological science and 4+ years of experience in pharmacovigilance in an analytical role
+ RN with 8+ years in pharmacovigilance in an analytical role.
+ 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 2+ years of pharmaceutical/biotechnology industry experience in Safety Science, Clinical Development, or Clinical Research is preferred.
+ US trained physicians must have achieved board eligibility or certification. Physicians trained outside the US who are not US board eligible or certified may be hired directly for employment in the US at the discretion of the Chief Safety Officer or appropriate delegate.
**Travel:**
+ Less than 10%.
**Computer Skills:**
+ Intermediate knowledge working with a safety database for retrieval of safety information.
+ Advanced knowledge of MedDRA.
+ MS Office Suite: Advanced application capability with Excel, PowerPoint, and Word.
+ Familiarity with data mining tools and exploratory analyses tools such as Spotfire.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
