Staff Design Quality Engineer (Global Expansions) DexComStaff Design Quality Engineer (Global Expansions)CaliforniaWorking cross-functionally with Systems Engineering, Design Engineering, Clinical, Regulatory Affairs, Quality, Manufacturing, Human Factors, and Post-Market Surveillance, this role integrates global medical device regulations – including FDA 21 CFR Part 820/QMSR, ISO 13485, EU MDR, ISO 14971 etc - into product development while ensuring patient safety and regulatory compliance. The Staff Design Quality Engineer (Global Expansions) serves as the principal technical authority for design control, product risk management, and regulatory compliance across international markets.
Associate Director or Director, Medical Science Liaison, Oncology - West Region / Field-based Eisai IncAssociate Director or Director, Medical Science Liaison, Oncology - West Region / Field-basedModesto, CA$206,600–$271,215 / yearThe Director, MSLs is responsible for the leadership, direction and management of MSLs in the region and works collaboratively with the Medical Affairs Senior management with strategic and tactical planning, working collaboratively with Medical Affairs and Clinical Development teams for support of clinical studies across the product portfolio. Skills:Communication & Cross-functional Influence, Critical Thinking & Agility, Healthcare Environment Dynamics, KOL/ HCP Engagement, Medical Data and Insights, People Development, Resource Planning & Management, Territory Management (MSL).
Senior Director, Clinical Research-Infectious Disease Vir BiotechnologySenior Director, Clinical Research-Infectious DiseaseSan Francisco, CA$235,500–$329,500 / yearVir Biotechnology is looking for a Senior Director, Clinical Research-Infectious Disease to facilitate late‑stage clinical development for our hepatitis delta (HDV) portfolio, with a primary focus on activities supporting the Phase III clinical program and health authority submission activities. Reporting to the VP, Clinical Research, this senior leader will serve as the key clinical voice in shaping and executing the clinical development strategy You will concentrate on advancing our HDV assets through global Phase III,BLA‑enabling activities and support on relevant commercial activities.
Senior Director, Clinical Development-Infectious Disease Vir Biotechnology IncSenior Director, Clinical Development-Infectious DiseaseSan Francisco, CA$235,500–$329,500 / yearVir Biotechnology is looking for a Senior Director, Clinical Development-Infectious Disease to facilitate late‑stage clinical development for our hepatitis delta (HDV) portfolio, with a primary focus on activities supporting the Phase III clinical program and health authority submission activities. Reporting to the VP, Clinical Development, this senior leader will serve as the key clinical voice in shaping and executing the clinical development strategy You will concentrate on advancing our HDV assets through global Phase III,BLA‑enabling activities and support on relevant commercial activities.
Senior Director, Real World Data RWD Freenome IncSenior Director, Real World Data RWDCARemote$236,300–$335,475 / yearAbout this opportunity: As the Senior Director of Real World Data (RWD), you will be accountable for defining, developing, and implementing our RWD strategy, platform, and data pipeline to transform diverse real-world datasets into regulatory-grade, research-ready assets that drive our clinical development, evidence generation, digital health products and product offerings. Specifically, the Senior Director will lead the RWD Informatics team in turning electronic health records (EHR), claims, imaging, and other RWD sources into research-ready datasets accessible by our biostatisticians,computational scientists and other end users while ensuring data quality, operational efficiency, and scalability.
Global Development Lead (Gdl), Clinical Development Revolution Medicines, Inc.Global Development Lead (Gdl), Clinical DevelopmentRedwood City, CA$369,000–$424,000 / yearPartner closely with the Project Team Leader (PTL) or Lifecycle Team Leader (LCL) to ensure that clinical development strategy, positions and decision-making are fully represented and integrated within lifecycle planning and decision-making for the molecule, with clear alignment on roles, decision rights and accountability. The GDL functions as the single point of clinical accountability for the assigned program, setting direction, driving alignment across functions, and representing the program at internal governance bodies and externally with investigators, key opinion leaders, and global health authorities.
Chief Risk Officer (On-site) SF Fire Credit UnionChief Risk Officer (On-site)San Francisco, CA$200,000–$285,000 / yearBe Personal – Walk the Member/Employee PathBe a Leader – Empower, Collaborate, OwnBe Outside the Box – Innovate, Educate, EngageBe Real – Integrity and Transparency MatterBe the Connection – Serve our CommunitySecond, will they thrive in a culture like ours, where we default to trust, embrace feedback, and desire to innovate? Vendor Management Manage the third-party risk management program, ensuring that third-party relationships are adequately assessed for sufficient controls (especially information security), risks and aligned with the credit union’s strategic goals.
Director, Technical Management iHerbDirector, Technical ManagementIrvine, CaliforniaGenerally requires a minimum of 12 years of experience in product development, regulatory affairs, or quality management within dietary supplements, nutraceuticals, OTC, or a related consumer health category. The Director, Technical Management is responsible for leading the formulation, regulatory compliance, quality assurance, product safety, and packaging/labeling functions for iHerb’s Owned Brands.
Exec Medical Director, Pharmacovigilance Risk Management (PVRM) Exelixis IncExec Medical Director, Pharmacovigilance Risk Management (PVRM)Alameda, CA$355,000–$504,000 / yearSUMMARY/JOB PURPOSE: The Executive Medical Director, PVRM is responsible for the development and execution of the global product safety strategy for complex clinical development program(s) as well as post-marketing pharmacovigilance activities for Exelixis products. Set a clear strategy for key safety deliverables for the product (e.g., safety signals, aggregate reports, risk management planning, safety data pooling, regulatory filing documents, clinical development documents).
Medical Science Liason (MSL) - Podiatry, Men’s Health and Ortho (Southwest) Mallinckrodt PharmaceuticalsMedical Science Liason (MSL) - Podiatry, Men’s Health and Ortho (Southwest)Los Angeles, CaliforniaRemoteThis is a field-based Medical Affairs position requiring a strong scientific background (technical or clinical experience) as the MSL will be a credible source of clinical/scientific data as well as technical/practical education to practicing clinicians, key opinion leaders (KOL), professional societies, and payers. A Medical Science Liaison (MSL) will serve as a liaison to the medical/scientific community and will be responsible for establishing, developing and maintaining relationships with key stakeholders within the geographic and therapeutic area of coverage.
Sr HR Business Partner (Northridge, CA) MinimedSr HR Business Partner (Northridge, CA)Los Angeles, CA$150,000–$256,000 / yearIf you are applying to perform work for MiniMed in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which MiniMed reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Regular employees working 20 or more hours per week are eligible for a robust benefits package, including health, dental, and vision insurance, as well as access to a Health Savings Account, Healthcare Flexible Spending Account, life insurance, long-term disability leave, and a dependent daycare spending account.
Director of Resource Management San José State UniversityDirector of Resource ManagementSan José, CaliforniaThe Director of Resource Management is responsible for revenue projections and estimates; budget development; monitoring budget versus fiscal expenditures; developing and enforcing policies and practices related to fiscal management; ensuring adequate funding is available to meet division and strategic priorities; development of business plans; leading professional development activities within the division; advising department staff regarding courses of action and compliance with purchasing, accounts payable, accounts receivable and personnel actions; leading development of a workforce strategy; and serving as a liaison with People and Culture on matters. The Director of Resource Management leads the division’s Budget, Finance, and Talent Acquisition committee and serves on a number of committees and leadership groups including but not limited to VPSA Council, Student Affairs Leadership Team, Finance Advisory Council, and Federal Work Study Oversight Committee.
Director of Resource Management California State UniversityDirector of Resource ManagementSan José, CAThe Director of Resource Management is responsible for revenue projections and estimates; budget development; monitoring budget versus fiscal expenditures; developing and enforcing policies and practices related to fiscal management; ensuring adequate funding is available to meet division and strategic priorities; development of business plans; leading professional development activities within the division; advising department staff regarding courses of action and compliance with purchasing, accounts payable, accounts receivable and personnel actions; leading development of a workforce strategy; and serving as a liaison with People and Culture on matters. Jeanne Clery Disclosure of Campus Security Policy and Crime Statistics Act and Campus Housing Fire Safety Notification: Pursuant to the Jeanne Clery Disclosure of Campus Security Policy and Campus Crime Statistics Act, the Annual Security Report (ASR) is also now available for viewing at https://www.sjsu.edu/clery/docs/SJSU-Annual-Security-Report.pdf .
Sr. Assistant Dean, Studen Srvcs Santa Clara UniversitySr. Assistant Dean, Studen SrvcsSanta Clara, CaliforniaResponsible for ensuring the accuracy and availability of student academic counseling for: JD, LLM and Masters of Law students; students in combined degree programs; students on directed study; students seeking specialty certificates; non-matriculating, visiting, and exchange students; and any other students registering for courses at the School of Law. Supervise full time office staff of 7, student staff of 4. Hire, train, evaluate, counsel, direct, and manage registrar, assistant registrar, student life director, systems managers, office manager and data entry clerk.
Senior Director, New Product Planning Mirum Pharmaceuticals IncSenior Director, New Product PlanningFoster City, CA$280,000–$315,000 / yearReporting to the SVP of Corporate Development and Strategy, the Senior Director, New Product Planning will help shape the company's future portfolio by leading commercial strategy for pipeline assets, identifying lifecycle opportunities, evaluating external innovation, and helping define new areas for growth. This individual will serve as the commercial strategy lead for pre-Phase 3 programs and partner closely with Research, Clinical Development, Medical Affairs, US and International Commercial, Business Development, Corporate Strategy, and Finance to integrate scientific, clinical, commercial, and financial perspectives into key development and investment decisions.
Vice President, Clinical Development Aura BioSearchVice President, Clinical DevelopmentCaliforniaThis role will oversee the strategic planning and execution of the metabolic and nephrology programs, while leading cross-functional Project Strategy Teams composed of Clinical Development, Operations, Regulatory, CMC, Medical Affairs, Commercial, and Project Management. The ideal candidate should bring significant expertise in clinical development, particularly in nephrology and rare diseases, and have experience managing the full lifecycle of therapeutics from pre-IND to commercialization, across multiple modalities.
Senior Director, Advanced Technologies & Innovations iRhythm Holdings IncSenior Director, Advanced Technologies & InnovationsCARemote$222,000–$288,000 / yearReporting directly to the Chief Medical & Scientific Officer and EVP, Advanced Technologies, this leader will drive the needs finding, landscape exploration and idea sourcing, conception, feasibility, and translation of new capabilities across AI, sensors, digital biomarkers, and data science into differentiated clinical and commercial solutions that are readied for product development. The leader operates as an extension of executive leadership team, as the steward of the Innovation Committee, and acts as a key integrator across the business, driving complex cross-functional initiatives across Product, Business Development, R&D, Science, Regulatory, Clinical, Commercial, and Corporate Strategy organizations.
Director, Organizational Learning & Development Arrowhead PharmaceuticalsDirector, Organizational Learning & DevelopmentLos Angeles, CA$190,000–$230,000 / yearArrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. This role ensures employees across R&D, Manufacturing, Quality, Regulatory Affairs, and Commercial functions are equipped with the knowledge and skills needed to perform their roles safely, compliantly, and effectively.
Director, Organizational Learning & Development Arrowhead Pharmaceuticals IncDirector, Organizational Learning & DevelopmentPasadena, CA$210,000–$250,000 / yearArrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. This role ensures employees across R&D, Manufacturing, Quality, Regulatory Affairs, and Commercial functions are equipped with the knowledge and skills needed to perform their roles safely, compliantly, and effectively.
Director, Medical Communications Summit Therapeutics IncDirector, Medical CommunicationsPalo Alto, CA$203,000–$253,000 / yearCollaborate cross-functionally with Medical Affairs (e.g., Field Medical (RMSDs), Patient Advocacy, Training, Medical Information and Medical Education), Regulatory, Clinical Development, and Commercial partners across the organization to ensure alignment and accuracy in messaging and to ensure a cohesive medical communications and engagement strategy. HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.