[Remote] Director, Safety Scientist

Note: The job is a remote job and is open to candidates in USA. BeOne Medicines is a company focused on fighting cancer, seeking experienced professionals for their growing team. The Director, Safety Scientist will lead safety signal detection, evaluation of safety data, and regulatory reporting while collaborating with various stakeholders. Responsibilities • 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 • Define data acquisition strategy, methodology, and approach for safety evaluations • Perform analysis of safety data and lead authoring of safety assessment • Drive collaboration with PSLs, Safety Scientists, Pharmacoepidemiologists, and 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 • Lead execution of signal assessment strategy and assess potential impact on the product safety profile with recommendation for action and initiate proposal for Safety Management Team • 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 and drive decision making • 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, 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 • Lead signal assessment documentation following BeiGene signal management and safety governance framework • 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, Safety Analysis Plans (SAPs), Tables Figures and Listings (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 PSLs and other Clinical Study Team (CST) members • Lead the authoring of Storyboards and Briefing Books for HA interactions • Support ad-hoc review of the Safety Management Plans • 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) for assigned compounds • 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 • Contribute to integrated Benefit/Risk assessments • Responsible for effective execution, communication and influence with internal stakeholders (e.g., clinical development, medical, regulatory, labeling) and external stakeholders (e.g. FDA, MHRA, EMA, other regulatory agencies) • Contribute to continuous employee development programs, such as mentoring, coaching, and peer-to-peer learning • Contribute to and provide Safety Science training to support team development • Identify and develop innovative approaches to continuously improve organizational effectiveness and productivity • Demonstrate knowledge and application of pharmacovigilance principles to related tasks that are high in complexity • Adhere to requirements in quality system document and process improvement initiatives to ensure compliance with internal processes, local laws and regulations • Execute any other tasks assigned by manager to assist in departmental activities • 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 • 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 Skills • 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 • 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 • Medical • Dental • Vision • 401(k) • FSA/HSA • Life Insurance • Paid Time Off • Wellness Company Overview • BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more accessible to cancer patients worldwide. It was founded in 2010, and is headquartered in Cambridge, Massachusetts, US, with a workforce of 10001+ employees. Its website is Company H1B Sponsorship • BeOne Medicines has a track record of offering H1B sponsorships, with 14 in 2025. Please note that this does not guarantee sponsorship for this specific role. Apply tot his job