Current jobs related to Head of Safety Science - Emeryville, California - BeiGene

  • Director of Safety Science

    2 weeks ago

    Emeryville, California, United States BeiGene Full time

    Job DescriptionGeneral Description:The Director of Safety Science will support assigned compounds in conjunction with Product Safety Leads (PSLs) and leverage 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...

  • Director of Safety Science

    2 weeks ago

    Emeryville, California, United States BeiGene Full time

    Job Title: Director, Safety ScientistJob Summary:The Director, Safety Scientist is a critical role within BeiGene, responsible for leading the detection of safety signals, evaluation of safety data, and assessment of safety risks. This position requires a strong clinical and scientific background, with expertise in pharmacovigilance and regulatory...

  • Head of Global Safety and Pharmacovigilance Lead

    2 weeks ago

    Emeryville, California, United States Kyverna Therapeutics Full time

    Job Title: Head of Global Safety and PharmacovigilanceKyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. Our innovative therapeutic platform leverages advanced T cell engineering to suppress and eliminate autoreactive immune cells at the...

  • Head of Analytical Development and Quality Control

    2 weeks ago

    Emeryville, California, United States Metagenomi Full time

    Job Title: Head of Analytical Development and Quality ControlMetagenomi is a gene editing company committed to developing potentially curative therapeutics by leveraging a proprietary toolbox of next-generation gene editing systems to accurately edit DNA where current technologies cannot. Our metagenomics-powered discovery platform and analytical expertise...

  • Associate Director, Safety Scientist

    2 weeks ago

    Emeryville, California, United States BeiGene Full time

    Job Title: Associate Director, Safety ScientistJob Summary:The Associate Director, Safety Scientist will be responsible for leading the safety assessment and risk management activities for assigned compounds. This role will work closely with the Safety Science group to conduct safety evaluations, signal detection, and risk assessment. The successful...

  • Safety Scientist Director

    1 week ago

    Emeryville, California, United States BeiGene Full time

    Job DescriptionJob Title: Director, Safety ScientistJob Summary: We are seeking a highly skilled and experienced Director, Safety Scientist to join our team at BeiGene. The successful candidate will be responsible for leading the detection of safety signals, evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and...

  • Associate Director, Safety Scientist

    1 month ago

    Emeryville, California, United States BeiGene Full time

    Job Title: Associate Director, Safety ScientistBeiGene is seeking an experienced Associate Director, Safety Scientist to join our team. As a key member of our Safety Science group, you will be responsible for supporting assigned compounds in conjunction with Product Safety Leads (PSLs) and leveraging clinical and scientific expertise to perform signal...

  • Associate Director, Safety Expert

    5 days ago

    Emeryville, California, United States BeiGene Full time

    The Associate Director, Safety Expert supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages clinical and scientific expertise to perform signal detection, evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and regulatory-required periodic reporting.Physicians in this role are also...

  • Associate Director, Safety Scientist

    5 days ago

    Emeryville, California, United States BeiGene Full time

    Job DescriptionOverviewThe Associate Director, Safety Scientist plays a critical role in supporting assigned compounds in conjunction with Product Safety Leads (PSLs) and leveraging clinical and scientific expertise to perform signal detection, evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and regulatory-required...

  • Health Sciences Senior Consultant

    1 month ago

    Emeryville, California, United States Ramboll Group AS Full time

    Job Title: Health Sciences Senior ConsultantRamboll is seeking a highly skilled Health Sciences Senior Consultant to join our team in Emeryville, CA.Job Summary:We are looking for a talented individual to assist with human health risk assessments for hazardous waste sites, Brownfield redevelopment sites, ambient air releases, and indoor air sources, as well...

  • Associate Director, Clinical Science

    2 weeks ago

    Emeryville, California, United States BeiGene Full time

    Job Summary:The Associate Director – Clinical Science will play a key role in supporting BeiGene Clinical and Medical assets by successfully executing clinical development programs and deliverables in partnership across the organization, with external vendors, and with external academicians and collaboration partners.Key Responsibilities:• Facilitate the...

  • Application Analyst III

    4 weeks ago

    Emeryville, California, United States Sutter Health Full time

    Job Title: Application Analyst IIISutter Health is seeking a highly skilled Application Analyst III to join our team. As a key member of our IT department, you will be responsible for configuring and developing Epic applications to achieve safety and efficiency goals.Responsibilities:Configure Epic applications to meet business needsDevelop and optimize Epic...

  • Chief Nursing Officer

    2 weeks ago

    Emeryville, California, United States Sutter Health Full time

    Job Title: Chief Nursing OfficerAt Sutter Health, we are seeking a highly skilled and experienced Chief Nursing Officer to lead our nursing team and provide strategic direction for nursing and clinical services across the organization.Key Responsibilities:Develop and implement strategic plans for nursing services in alignment with the organization's mission...

  • Imaging PET/CT Technologist

    2 weeks ago

    Emeryville, California, United States US Oncology Network-wide Career Opportunities Full time

    Job Title: Imaging PET/CT TechUS Oncology Network-wide Career Opportunities is seeking a skilled Imaging PET/CT Tech to join our team.Job Summary:We are looking for a highly motivated and detail-oriented Imaging PET/CT Tech to perform diagnostic PET/CT and CT imaging procedures. The ideal candidate will have a strong background in nuclear medicine and be...

  • Chief Nursing Officer

    1 month ago

    Emeryville, California, United States Sutter Health Full time

    Job Summary:The Chief Nursing Officer (CNO) will provide strategic leadership and direction for nursing and clinical services across the organization. This role will be responsible for ensuring the highest standards of nursing care delivery, patient safety, and clinical outcomes across all departments and facilities.Key Responsibilities:Develop and implement...

  • Soil Processing Laboratory Technician

    2 weeks ago

    Emeryville, California, United States Pattern Ag Full time

    Job Title: Soil Processing Laboratory TechnicianPattern Ag is an agricultural technology company that leverages advances in genomics, data science, and microbiology to help farmers improve the productivity and profitability of their land. We are seeking a skilled Laboratory Technician to support our high-throughput soil processing operations.Job SummaryThe...

  • Soil Processing Laboratory Assistant

    5 days ago

    Emeryville, California, United States Pattern Ag Full time

    Job Title: Soil Processing Laboratory AssistantPattern Ag is an agricultural technology company leveraging advances in genomics, data science, and microbiology to help farmers improve the productivity and profitability of their land.We are seeking a highly skilled and detail-oriented Soil Processing Laboratory Assistant to support our high-throughput soil...

  • Soil Processing Laboratory Technician

    2 weeks ago

    Emeryville, California, United States Pattern Ag Full time

    Job Title: Soil Processing Laboratory TechnicianPattern Ag is an agricultural technology company leveraging advances in genomics, data science, and microbiology to help farmers improve the productivity and profitability of their land. By applying genomic analysis to farm soil, we unlock a wide range of predictive insights that help farmers optimize their...

  • Chief Nursing Officer

    3 weeks ago

    Emeryville, California, United States Sutter Health Full time

    Job Summary:The Chief Nursing Officer (CNO) will provide visionary leadership and direction for nursing and clinical services across Sutter Health. This role requires a strategic thinker who can develop and implement plans to ensure the highest standards of nursing care delivery, patient safety, and clinical outcomes.Key Responsibilities:Develop and...

  • Food MSAT Senior Manager

    1 month ago

    Emeryville, California, United States UPSIDE Foods Full time

    About UPSIDE FoodsUPSIDE Foods is a pioneering company in the field of cultivated meat production. Based in Berkeley, CA, we are dedicated to creating a more sustainable and humane food system. Our mission is to make delicious meat products without the need to raise and slaughter animals.Job DescriptionWe are seeking a highly skilled Food MSAT Senior Manager...

Head of Safety Science

2 months ago

Emeryville, California, United States BeiGene Full time

General Overview:

The Head of Safety Science plays a pivotal role in overseeing the safety evaluation of assigned compounds, collaborating closely with Product Safety Leads (PSLs). This position requires leveraging clinical and scientific knowledge to identify safety signals, assess safety data, and respond to regulatory inquiries while ensuring compliance with global standards. The individual in this role is expected to provide comprehensive medical safety assessments and engage effectively with both internal and external stakeholders.

Key Responsibilities:

This job description outlines the primary responsibilities associated with this position, which may evolve over time. Please consult with your supervisor for specific duties.

Core Functions:

Signal and Safety Data Analysis

  • Lead the identification and evaluation of safety signals from diverse data sources to inform potential label changes or benefit-risk assessments.
  • Establish strategies for data acquisition and methodologies for safety evaluations.
  • Conduct thorough analyses of safety data and oversee the drafting of safety assessments.
  • Facilitate collaboration with PSLs, Safety Scientists, and cross-functional teams to ensure comprehensive safety data evaluations.
  • Implement signal assessment strategies and evaluate their implications on product safety profiles, recommending actions as necessary.
  • Prepare and present safety data at governance meetings and committees.
  • Utilize sound judgment in scientific discussions and decision-making processes.
  • Communicate critical safety information to core teams and stakeholders promptly.
  • Oversee the development and review of safety communication documents in collaboration with relevant teams.
  • Ensure compliance with BeiGene's signal management and safety governance frameworks.

Clinical Trial Oversight

  • Supervise the review of safety data and monitor patient safety during clinical trials.
  • Contribute safety expertise to the development of study protocols and related documents.
  • Lead the drafting of safety sections for regulatory submissions, collaborating with clinical study teams.
  • Author materials for health authority interactions.
  • Support the review of Safety Management Plans as needed.
  • Provide training on Safety Science to investigators.

Risk Management and Regulatory Compliance

  • Analyze safety data and prepare relevant sections for global regulatory inquiries and periodic reports.
  • Manage additional evaluation requests from health authorities with a focus on quality.
  • Identify safety-related inquiries and assess their impact on documentation.
  • Develop strategies and responses to safety questions from regulatory bodies.
  • Contribute to integrated Benefit/Risk assessments.

Advancing Pharmacovigilance

  • Engage effectively with internal and external stakeholders to promote safety science initiatives.
  • Participate in employee development programs, including mentoring and training.
  • Identify innovative strategies to enhance organizational effectiveness.
  • Ensure adherence to quality systems and compliance with regulations.
  • Perform additional tasks as assigned by management.

Supervisory Role:

This position may involve direct reports, depending on the specific program or portfolio. The Head of Safety Science will provide essential support as an experienced safety scientist, leading high-quality scientific and operational analyses in accordance with BeiGene processes.

Required Qualifications:

  • PharmD, NP, RN, or PhD in a medical or biological field with over 8 years of experience in Safety Science.
  • Alternatively, an MD with relevant clinical training and significant experience in Safety Science or Clinical Development.

Other Qualifications:

  • Experience in matrix management and regulatory agency interactions.
  • Strong clinical knowledge across various disease states and drug effects.
  • Proven ability to manage multiple priorities effectively.
  • Demonstrated leadership and organizational skills.

Travel Requirements:

Minimal travel expected (less than 10%).

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.