Associate Director, Safety Scientist (Early Development)

Emeryville, CA, United States

**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 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:**

+ Lead the monitoring of the safety of patients on allocated clinical trials.

+ Lead the development of safety contents and contribute to Data Monitoring Committees or Safety Monitoring Committee.

+ Lead signal detection and related tasks which are high in complexity, or which concern high complexity product.

+ Lead execution of signal assessment strategy and assess potential impact to the product safety profile with recommendation for action.

+ Lead signal assessment and documentation following BeiGene signal management and safety governance framework.

+ Demonstrated ability to strategic apply PV principles and regulations to related tasks that are high in complexity.

+ Lead the preparation of safety-related sections and associated documentation for safety, clinical and regulatory documents, with appropriate assessment of impact, dependencies, and proposal for Safety Management Team.

+ Lead safety science contributions, critically review documents (e.g., Protocols, IBs, ICFs, SAPs/ TFLs, Medical Monitoring Plans, CSRs (incl. China ADR Summary), ad-hoc safety queries, health authority questions, etc.), proactively resolve issues, propose solutions, and escalate to PSL accordingly.

+ Collaborate with Data Analytics, Biostats and Data Management to ensure that outputs of safety data from both safety and clinical trial databases are standardized and of high quality to meet the need for preparation of aggregate safety reports including DSUR, PBRER and other required aggregate safety analyses required by regulatory authorities.

+ Contribute/ author to safety sections and review of aggregate safety reports.

+ Author and review 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.

+ Contribute high quality content to Storyboards and Briefing Books for HA interactions.

+ Contribute to the authoring and maintenance of the Safety Surveillance Plans.

+ Provide analysis and insight for integrated Benefit/Risk assessments.

+ Actively contribute to product safety surveillance, coordinating aspects of signal evaluation/safety review activities e.g., Scheduled review of scientific literature, SAE listings, data-mining and data outputs from the safety database and the clinical database to identify potential risks, emergent safety issues and signals.

+ Lead evaluation of safety topics and issues and author safety assessment reports under

+ Author and maintain RSI for use in IBs.

+ Contribute to the development and maintenance of the Company Core Safety Information (CCSI), propose edits, manage approval of amendments and contribute to safety summaries to support changes to the CCDS.

+ Contribute to development of Package Insert and labeling updates, develop labeling prose text updates, based on internal aggregated reports.

+ Develop labeling update impact summaries, justification documents and regulatory responses for use by RA for PI/ SmPC Type II variations.

+ Contribute to the authoring and maintenance of core RMPs and local Risk Management Plans/ REMS.

+ Assist in leading and improving the oversight and monitoring of effectiveness of the risk minimization measures.

+ Assist in the internal and external dissemination of important new safety information or actions (e.g. DHCP/DHPC letters) and improvement of notification processes.

+ Present to the Safety Management Team (SMT) and actively participate and take minutes at Company Safety Committee (SCS) when required.

+ Maintain and enhance knowledge of safety profiles for allocated products, including both BeiGene and competitor products.

+ Lead liaison with commercial/ marketing team(s) to evaluate safety impact and provide input and improvement into program design (e.g., Non-Interventional Programs, market research, patient support programs).

+ Lead the evaluation of current processes and assesses alignment with regulatory expectations, guidelines, mandates for regulatory inspections.

+ Support an environment of continuous improvement within the team and contributes to continuous improvement initiatives and inspection readiness across GPS.

+ Assist with the creation of safety sciences processes for BeiGene and competitor products.

+ Coach junior safety scientists. Train and mentor staff to deliver high quality outputs and documents.

+ Any other tasks assigned by manager to assist in departmental activities.

**Required Education:**

+ PharmD, NP, RN or PhD in a medical field or biological science and 8+ years in pharmacovigilance in an analytical role.

+ MS in a medical field or biological science and 7+ years in pharmacovigilance in an analytical role.

+ BA degree with 10+ years overall experience.

**Required Qualifications:**

+ Prior experience as a Safety Scientist and competency around safety scientist core responsibilities including:

+ Signal detection and signal management strategy and execution.

+ Aggregate safety analysis with a particular focus on early development for Phase I, Phase II/III, and filing pharmacovigilance activities.

+ Pharmaceutical product development experience.

+ Experienced in global regulatory requirements for pharmacovigilance.

+ Prior people management experience is a plus.

+ Prior experience with Regulatory Agency interactions preferred but not essential.

**Supervisory Responsibilities:**

+ None at the onset.

**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.

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