Safety Scientist Associate Director
1 week ago
The Associate Director, Safety Scientist plays a crucial role in supporting assigned compounds, collaborating with Product Safety Leads, 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 periodic reporting.
This position requires effective prioritization, critical thinking, and judgment-based decision making to execute key deliverables in compliance with global regulations and internal processes.
The Associate Director, Safety Scientist is responsible for leading the identification, analysis, and evaluation of safety data for signal detection from all applicable sources, proposing and leading data acquisition strategy, methodology, and approach for safety evaluations, and collaborating with cross-functional personnel to ensure thorough evaluation and aggregate analysis of safety data.
This role also involves executing signal assessment analysis per strategy, assisting with the preparation of presentations for Safety Management Team and Company Safety Committee, and preparing and supporting the presentation of safety data at safety governance meetings.
The Associate Director, Safety Scientist will also contribute to effective execution, communication, and influence with internal stakeholders and external stakeholders, and adhere to requirements in quality system documents and process improvement initiatives to ensure compliance with internal processes, local laws, and regulations.
Key Responsibilities- Lead the identification, analysis, and evaluation of safety data for signal detection from all applicable sources
- Propose and lead data acquisition strategy, methodology, and approach for safety evaluations
- Collaborate with cross-functional personnel to ensure thorough evaluation and aggregate analysis of safety data
- Execute signal assessment analysis per strategy
- Assist with the preparation of presentations for Safety Management Team and Company Safety Committee
- Prepare and support the presentation of safety data at safety governance meetings
- Contribute to effective execution, communication, and influence with internal stakeholders and external stakeholders
- Adhere to requirements in quality system documents and process improvement initiatives to ensure compliance with internal processes, local laws, and regulations
- PharmD, NP, RN, or PhD in a medical field or biological science and 6+ years of experience as a Safety (Pharmacovigilance) Scientist
- OR 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 ideally 2+ years of pharmaceutical/biotechnology industry experience in Safety Science, Clinical Development, or Clinical Research
-
Associate Director, Safety Scientist
2 weeks ago
San Mateo, California, United States BeiGene Full timeJob Title: Associate Director, Safety ScientistJob Summary:The Associate Director, Safety Scientist is a critical role within BeiGene's Safety Science team, responsible for supporting assigned compounds and leveraging clinical and scientific expertise to perform signal detection, evaluation of safety data, assessment of safety risks, responses to regulatory...
-
San Mateo, California, United States BeiGene Full timeJob Title: Executive Medical Director, Product Safety Physician LeadThe Executive Medical Director serves as the Lead Product Safety Physician for multiple or large complex strategically important developmental programs (often multi-indication) and creates and maintains a single interpretation of global safety data for developmental and marketed products.Key...
-
Senior Associate Scientist, Oncology Research
4 weeks ago
San Mateo, California, United States GILEAD Sciences Full timeJob Title: Senior Associate Scientist, Oncology ResearchGilead Sciences is seeking a highly motivated and experienced Senior Associate Scientist to join our Oncology Research group. As a key member of our team, you will contribute to the discovery, research, and development of novel therapeutic agents to address unmet medical needs of cancer patients.Key...
-
San Francisco, California, United States Nurix Full timeJob SummaryThe Senior Scientist/Associate Director of Clinical Biomarkers will play a pivotal role in advancing biomarker strategies to support the clinical development of Nurix's innovative therapies targeting protein homeostasis.This position requires a leader who can collaborate across research, clinical development, and external partnerships to drive the...
-
Director of Safety and Civility
2 weeks ago
San Mateo, California, United States 2K Full timeAbout the Role:We're seeking a seasoned Product Manager to lead our Safety team at Roblox. As the Director of Product for Safety, you'll oversee a team of product managers to ensure our platform is a safe and welcoming space for our community.Our team works closely with other departments to develop and implement safety features, policies, and tools that...
-
Principal Drug Safety Scientist
4 weeks ago
San Diego, California, United States Neurocrine Bioscience Full timeAbout the RoleWe are seeking a highly skilled Principal Drug Safety Scientist to join our team at Neurocrine Biosciences. As a key member of our pharmacovigilance department, you will be responsible for providing scientific and clinical expertise to support the development and implementation of safety strategies for our products.Key ResponsibilitiesProvide...
-
Clinical Scientist Director
5 days ago
San Diego, California, United States Alterome Therapeutics Full timeJob Title: Associate Director/Director, Clinical ScientistJob Summary:We are seeking an experienced Clinical Scientist to join our Oncology Clinical Development team at Alterome Therapeutics, Inc. The successful candidate will contribute to the development, planning, and execution of clinical studies, ensuring scientific integrity and interpretation of study...
-
Director of Product, Safety Platforms
1 week ago
San Mateo, California, United States Roblox Full timeAbout the RoleAt Roblox, we're building a platform that empowers our community to bring any experience to life. As the Director of Product for Safety, you'll oversee a team of product managers to ensure that Roblox is a safe place for our community. Our team works on the tooling, policies, data, measurement, and developer/end-user features around safety,...
-
Associate Director, Protein Sciences
4 days ago
San Diego, California, United States Calibr Full timeJob SummaryCalibr is seeking an exceptional Associate Director to lead the protein sciences team within the biologics drug discovery group. This role will be responsible for directing a group of scientists to design, produce, and characterize protein candidates. The successful candidate will have a strong background in protein expression platforms, protein...
-
Research Scientist III
2 weeks ago
San Mateo, California, United States Net2source Full timeJob Title: Associate Scientist - Biology Immuno-oncologyWe are seeking a highly motivated and talented Associate Scientist to join our Immuno-oncology group at Net2source. Our collaborative and interdisciplinary research team utilizes state-of-the-art technologies and innovative methodologies to advance medicines into the clinic.The successful candidate will...
-
San Mateo, California, United States Vaxcyte Inc Full timeJob Title: Associate Scientist I, Upstream Process DevelopmentJob SummaryVaxcyte Inc. is seeking a highly motivated and experienced Associate Scientist to join our Protein Process Development group. The successful candidate will be responsible for developing robust, scalable, and cost-effective upstream (cell-free) procedures for the GMP manufacture of early...
-
Associate Director Clinical Scientist
4 weeks ago
San Francisco, California, United States Daiichi Sankyo, Inc. Full timeAbout Daiichi Sankyo, Inc.Daiichi Sankyo, Inc. is a global pharmaceutical company dedicated to creating innovative therapies to improve patient outcomes. With a rich legacy of innovation and a robust pipeline of promising new medicines, we are committed to addressing unmet medical needs and improving standards of care.Job SummaryWe are seeking an experienced...
-
Data Scientist
1 week ago
San Mateo, California, United States Roblox Full timeUser Growth StrategiesAt Roblox, we're building a platform that empowers our community to bring any experience to life. As a Data Scientist in our User group, you'll play a critical role in driving our understanding of user engagement. Your expertise in data science, statistics, and causal inference will help us enhance user growth strategies focused on...
-
Principal Drug Safety Scientist
2 weeks ago
San Diego, California, United States Neurocrine Biosciences Full timeAbout the RoleWe are seeking a highly skilled Principal Drug Safety Scientist to join our team at Neurocrine Biosciences. As a key member of our pharmacovigilance team, you will be responsible for providing scientific and clinical expertise to support the development and implementation of safety strategies for our clinical trials.Key ResponsibilitiesProvide...
-
Research Scientist Intern
2 weeks ago
San Mateo, California, United States Gilead Sciences Full timeInternship Opportunity at Gilead SciencesGilead Sciences, a leading biopharmaceutical company, is seeking highly motivated and talented individuals to join our team as Research Scientist Interns. As a Research Scientist Intern, you will contribute to high-impact projects that advance our company's mission to create a healthier world for all people.Key...
-
QC Associate Scientist
2 weeks ago
San Diego, California, United States Simply Biotech Full timeJob Title: QC Associate ScientistSimply Biotech is seeking a highly skilled and detail-oriented QC Associate Scientist to join our team in San Diego, CA.Job Summary:The QC Associate Scientist will be responsible for performing various analytical and physical testing techniques to support cGMP and development activities. This includes performing required...
-
Research Scientist
5 days ago
San Mateo, California, United States Gilead Sciences Full timeResearch Scientist RoleAt Gilead Sciences, we're committed to creating a healthier world for all people. Our team of dedicated researchers works tirelessly to develop innovative therapies that improve lives and ensure access to these therapies across the globe.We're seeking a highly motivated and talented Research Scientist to contribute to our Discovery...
-
San Diego, California, United States Bristol-Myers Squibb Full timeTransforming Patients' Lives through ScienceBristol Myers Squibb is a leading pharmaceutical company dedicated to transforming patients' lives through science. We are seeking a highly skilled Associate Director/Senior Principal Scientist of Translational Medicine to join our team.Key Responsibilities:Design and implement program-specific late development...
-
Data Scientist
2 weeks ago
San Mateo, California, United States Roblox Full timeDrive User Growth with Data Science at RobloxJoin our mission to connect a billion people with optimism and civility. As a Data Scientist in our User Growth team, you'll play a critical role in enhancing user frequency and retention strategies. You'll collaborate with cross-functional teams to drive actionability and develop analytics frameworks to inform...
-
San Mateo, California, United States GILEAD Sciences Full timeJob SummaryGilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for over three decades. We are committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. As a Senior Associate Scientist, Biologics Quality Control, you will play...
