Director, Drug Safety — Strategic Safety & Regulatory Lead
LeonaBio, Inc.
LeonaBio, Inc. in the Seattle area seeks a Director of Drug Safety to lead pharmacovigilance strategy across two development programs, guiding safety data, risk management, and regulatory interactions. This hands-on leadership role builds core safety infrastructure in a lean biotech setting. You will oversee signal detection, DSURs, PSURs, and ISS development, collaborate with clinical, regulatory, and CMC teams, and serve as safety lead for FDA engagements, while mentoring future safety #J-18808-Ljbffr LeonaBio, Inc.
Vacancy posted 5 days ago
Similar jobs that could be interesting for youBased on the Director, Drug Safety — Strategic Safety & Regulatory Lead in Bothell, WA vacancy
$222.29k - $294.01k
...including antibody-drug conjugates. Our... ...Associate Medical Director, Pharmacovigilance... ...and oversight of safety management activities... ...with corporate and regulatory objectives.... ...emerging safety signals, leading benefit-risk... ...Strong analytical and strategic thinking skills with...RegulatoryFull timeImmunome, Inc.
Bothell, WAa month ago$177.57k - $212.16k
..., including antibody-drug conjugates. Our pipeline... ...experienced and strategic Associate Director / Director, Clinical... ...that balance patient safety, scientific value, and... ...Oversight and Execution Lead the scientific... ...scientific communication. Regulatory and Documentation Support...RegulatoryFor contractors$288.03k - $353.64k
...edge therapies, including antibody-drug conjugates. Our pipeline includes... ...seeking a highly experienced and strategic Senior Director, Pharmacometrics to lead model-informed drug development... ...dose selection and optimization, regulatory submissions, and product labeling...Regulatory$209.5k - $283.4k
...applied across all levels of strategic and tactical operations, providing... ..., cost, reliability and safety. Designs, develops, executes... ...laboratory activities comply with regulatory guidelines, and quality and/... ...product development process. Leads and directs the work of other...RegulatoryContract workWork at office$200.85k - $227.32k
...therapies, including antibody-drug conjugates. Our pipeline... ...OverviewThe Associate Director / Director, Biostatistics... ...project development plans, and regulatory issues.Provide strategic statistical input into... ...resolve data issues.Develop and lead initiatives in process...Regulatory$157.9k - $315.9k
...Workforce Classification: Hybrid Director, Total Rewards As the... ...talent. You will define and lead a forward‑looking Total Rewards... ...Executive Thought Partner Serve as a strategic advisor to senior leaders,... ...consistent execution and regulatory alignment. What You Will Bring...RegulatoryPremera Blue Cross
Mountlake Terrace, WA2 days ago$270k - $290k
...sclerosis (ALS). Our lead programs,... ...is seeking a Senior Director, Biostatistics to provide strategic and hands-on leadership... ...strategy throughout the drug development... ...data interpretation, regulatory submissions, and health... ...interim analyses, Data Safety Monitoring Boards (...RegulatoryTemporary workInterim roleImmediate startFlexible hoursLeonaBio, Inc.
Bothell, WA4 days ago$177.4k - $238.96k
...therapies, including antibody-drug conjugates. Our pipeline includes... ...is seeking an Associate Director / Director, Regulatory Affairs CMC, responsible for developing... .... Serve as the regulatory CMC lead on cross-functional teams, providing strategic input to technical operations,...RegulatoryFlexible hours$157.9k - $315.9k
...to grow, innovate, and lead with purpose. By... ...Healthsource blog: . As the Director, Total Rewards , you... ...serve as a trusted strategic advisor to senior... ...strong governance, and regulatory alignment. What You... ...prevention, and patient safety. We deliver these programs...RegulatoryFull timeWork experience placementPremera Blue Cross
Mountlake Terrace, WA3 days ago- ...of improving patients’ lives. Our lead drug candidates, lasofoxifene and ATH-... .... About this role Senior Director, Medical Affairs serves as the strategic scientific leader for the company... ...Commercial, Clinical Development, Regulatory, and other teams. Build and maintain...Regulatory
$220k - $250k
...lateral sclerosis (ALS). Our lead programs, lasofoxifene and... ...LeonaBio is seeking a Director, Drug Safety to lead drug safety and pharmacovigilance... ...partner, providing strategic safety guidance, leading... ...activities, and supporting regulatory submissions and health authority...RegulatoryTemporary workImmediate startFlexible hoursLeonaBio, Inc.
Bothell, WA5 days ago$170k - $180k
...of the role. We are seeking a strategic and dynamic Category/Supplier Director to enhance business success and... ...candidate has experience leading future-state transformation strategies... ...supplier compliance, product safety standards, regulatory requirements, and Code of...RegulatoryOngoing contractContract workSummer workLocal areaRemote work$180k - $240k
...SystImmune is a leading and well-funded clinical-stage... ...using its established drug development platforms,... ...seeking an Associate Director or Director of Protein... ...Prior contribution to regulatory filings (IND/IMPD) and... ...across functions as a strategic and operational...RegulatoryFull timeSystimmune
Bothell, WA20 days ago- FUJIFILM Sonosite in Bothell, WA seeks an HR Business Partner to act as a strategic advisor, aligning people strategies with business goals across the full employee lifecycle. You will provide guidance on performance, learning, and change initiatives while ensuring legal...
$95k - $125k
...Overview The Human Resources Business Partner (HRBP) serves as a strategic advisor and trusted partner to business leaders, aligning... ...as a subject matter expert on the local labor market and regulatory environment. Knowledge/Experience : ~ Bachelor's degree...RegulatoryFull timeWork at officeLocal areaFUJIFILM Biotechnologies
Bothell, WA13 days ago$150k - $200k
...SystImmune is a leading and well-funded clinical-stage... ...using its established drug development platforms,... ...Manager or Associate Director of Statistical... ...of datasets, TLGs, and regulatory submissions, manages and... ...leader maintaining a strategic prospective with regard...RegulatoryFull timeContract workWorldwideSystimmune
Bothell, WA12 days ago$214.9k - $358.1k
...The Global Development Lead (GDL) represents Clinical... ..., statistics, safety, commercial, patient access... ...in support of worldwide regulatory submissions. The individual... ...area and in clinical drug development. They... ...stakeholders, to drive strategic insight generation to support...RegulatoryPermanent employmentH1bLocal areaWorldwideVisa sponsorshipWork visaRelocation package2 days per weekPfizer
Bothell, WA2 days ago- ...Premera seeks a Director, Total Rewards to define and lead the enterprise Total Rewards strategy, aligning compensation, benefits, and wellness with business... ...Rewards team, oversee vendor governance, and ensure regulatory alignment while leveraging analytics to optimize...Regulatory
3M HEALTHCARE
Mountlake Terrace, WA2 days ago $130.9k - $277.2k
...for sourcing, negotiating, and closing strategic land transactions. You will drive market... ...expertise, the ability to navigate diverse regulatory and cultural environments, and the... ...people management experience, including leading, coaching, and developing high-performing...RegulatoryOngoing contractLocal area3 days per week$191.8k - $269.4k
...other Partners, Practitioners, and Practice Leads to shape service offerings.Shape Go-to-... ...governance, quality assurance, and regulatory compliance. Leads in applying Armanino delivery... ...'s PVAs, ensuring alignment with the strategic vision while maintaining high employee...RegulatoryFull timeContract workLocal areaFlexible hours$100k - $125k
...management of team members, reducing legal risks, and ensuring regulatory compliance. Provides guidance and input on business unit... ...better informed decisions. Demonstrated ability to think strategically and creatively within a fast-paced business environment. The...RegulatoryFull timeSono Bello
Bellevue, WA1 day ago$80k - $110k
...information, reporting and metrics. You’ll lead a team of Payroll & HR professionals... ...for external parties/auditors. Monitor regulatory and legislative changes, on both the state... ...decisions; applies critical thinking both strategically and tactically; is a wiz with Excel....Regulatory$110k - $130k
...Title: Culinary Director Location: Redmond... ...This role requires a strategic, hands-on leader ready... ...-code compliance. Lead cross-concept standardization... ...culinary techniques, safety, and operational best... ...high audit scores and regulatory compliance....RegulatoryFull timeCasual workSeasonal workNight shiftWeekend workKizuki Ramen and Izakaya
Redmond, WA3 days ago$171k - $231.4k
...job responsibilities- Program Leadership: Lead large-scale, complex technical programs... ..., from inception to delivery- Strategic Planning: Develop and execute comprehensive... ...senior leadership, external partners, and regulatory bodies, ensuring clear communication and...RegulatoryLocal areaImmediate startFlexible hours- Premera Blue Cross seeks a Director, Total Rewards to design and execute a comprehensive... ...in a competitive market. You will lead a high-performing team, oversee governance and analytics, and ensure regulatory compliance while driving strategic initiatives that support Premera's...Regulatory
$130k - $160k
Verathon Inc. is hiring a Senior HR Business Partner in Bothell, WA. This role focuses on embedding strategic HR across business functions, ensuring alignment with Verathon’s growth objectives. The ideal candidate will leverage their extensive HR experience to advise leadership...- TransWest Mobility is seeking a Transportation Safety Supervisor to support safety program development and regulatory compliance across DOT, OSHA, FMCSA standards. You... ...and continuous improvement, with opportunities to lead safety initiatives, inspections, and risk...Regulatory
- FUJIFILM Sonosite is seeking an HR Business Partner to act as a strategic advisor to leaders, aligning people strategies with business goals. You will balance strategic partnership with hands-on execution across the full employee lifecycle, ensuring compliance and fostering...
- FUJIFILM Sonosite is seeking an HR Business Partner to act as a strategic advisor to business leaders, aligning people strategies with goals and driving performance across the full employee lifecycle in the Bothell area. The role balances strategic partnership with hands...
$287.89k - $333.5k
...therapies, including antibody-drug conjugates. Our... ...Immunome as Associate Director / Director, Clinical Development... ..., Data Management, Regulatory Affairs,... ...implementation, patient safety oversight, medical monitoring... ...and external partners. Lead clinical trial data publication...Regulatory
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Director, Drug Safety — Strategic Safety & Regulatory Lead. Be the first to apply!
Related searches
- planning manager Bothell, WA
- director of strategy Bothell, WA
- strategic planning director Bothell, WA
- planning director Bothell, WA
- strategic planning manager Bothell, WA
- director strategy and innovation Bothell, WA
- strategic director Bothell, WA
- planning supervisor Bothell, WA
- regulatory scientist Bothell, WA
- regulatory cmc Bothell, WA