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Reporting to the Chief Medical Officer (CMO), the Vice President of Clinical Development manages the clinical development of drug candidates, creating strategies and plans for registration and commercial success. The role requires a deep understanding of all phases of pharmaceutical drug development, regulatory experience, and collaboration with key stakeholders (Biometrics, Research, Medical Affairs, Regulatory Affairs, etc.. Design, plan, execute, interpret, and communicate clinical trials and research results, in collaboration with the CMO. Oversee pharmacovigilance activities, ensuring safety monitoring and regulatory compliance. M.D. degree with advanced knowledge in hematology/oncology; board certification preferred.
Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.. You will provide strategic input and management oversight of regulatory labeling activities for multiple products across the Virology therapeutic area.. Oversees and guides the preparation and maintenance of regulatory labeling for multiple products across the Virology therapeutic area.. Oversees and guides or otherwise leads review/approval of U.S. labeling in Structured Product Labeling (SPL) format, artwork requests, archiving labeling documents, and updating label histories.. Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences.
Design and deploy AI/GenAI solutions in areas such as member engagement, care management, utilization management, risk adjustment, and fraud detection. Bachelor's degree in Computer Science, Engineering, Data Science, Healthcare Administration, or related field (Master's or MBA preferred). Strong understanding of the U.S. healthcare payer ecosystem-commercial, Medicare, Medicaid-and associated data systems (claims, EMR, HEDIS, etc.. Experience in responsible AI governance, data privacy (HIPAA), and regulatory compliance. Experience with GenAI tools and platforms (OpenAI, Anthropic, Vertex AI, Bedrock, etc.)
This includes innovative medical device studies and a complex global observational study in maternal health. Leads the planning and execution of clinical trials across multiple concurrent programs, including pharmaceuticals, medical devices and diagnostic studies in womens health. Bachelors degree or equivalent plus a minimum of ten years of clinical trials management experience, preferably within the women's health field (in-house pharmaceutical or biotechnology company experience desirable).. Experience in womens health is preferred; maternal health and perinatal research experience is a significant plus.. IN OFFICE PRESENCE: Please refer to the Hybrid and Remote Work Guidelines for in-office presence.
We are a medical device startup developing a wearable device to support continuous patient health monitoring in clinical trials.. The role involves guiding us through regulatory strategy, preparing submission documents, coordinating biocompatibility and electrical safety testing, and ensuring compliance with applicable standards.. Prepare for full FDA submissions and ongoing compliance. Proven experience implementing or managing Quality Management Systems (QMS) for medical devices. Sign in to set job alerts for “Regulatory Affairs Consultant” roles.
Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases.. The Senior Manager/Associate Director of Clinical Quality Assurance Auditor is responsible for partnering with cross functional teams to manage the audit program and conducting audits (routine & for-cause clinical investigator site, vendor, CSR and internal audits).. Under the direction of the Executive Director of Clinical Quality Assurance, establish key processes and maintain the Nurix GCP QA audit program, policies, and procedures.. Ensure compliance with applicable health authority regulations and guidelines for document management, TMF, and software used in GCP processes.. Deep knowledge and understanding of drug development process, global regulations, and interfacing related to GXP, and GCP authorities
The IT Senior Manager, R&D and Quality Systems is responsible for implementing and supporting R&D and quality business systems required for drug development in the cGMP environment. This position is responsible for the business analysis, planning, project management, implementation, computer systems validation and ongoing support of business applications in the areas of Research & Development Analytical, Regulatory Affairs, Clinical, Quality Affairs and Quality Control. Manages the application support of R&D and Quality systems to ensure they meet business needs and user requirements, remains in compliance per cGMP requirements and GAMP5 guidelines. Experience with R&D, Brand, Quality Assurance / Quality Control, Regulatory Affairs, Clinical, Manufacturing environments regulated by the FDA. Experience with Waters CDS, Trackwise, LIMS, Electronic Regulatory Filing System, Document Management, Quality Systems, Laboratory Operations.
The key functions of this role will be to collaborate with internal and external stakeholders including the Foster City Medical Affairs team, Scientific Publications, Medical Affairs Research, Marketing, Global Commercial Product Strategy, Value and Market Access, Clinical Research, Public Affairs, Government Affairs, Contracts/Finance, Pharmacology, Virology and Legal on both the global and regional levels.. Serve as Medical Affairs therapeutic area expert on Global Publications and Scientific Message Platform committees and other support for Scientific Communications. Oversee medical and scientific review of promotional materials for GRC and MRC. Must be fully cognizant and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities; thorough knowledge of FDA regulations, ICH guidelines and GCPs governing the conduct of clinical trials. Bachelor's degree a minimum, but M.D., D.O., PhD (biological or pharmaceutical sciences), or PharmD preferred.
Our program seeks to build cohorts of academic investigators with ongoing projects that are at any stage in drug development between having a validated target and ready to enter clinical trials.. We are seeking a highly motivated and innovative individual to join our team as a Learning Experience Designer.. The ideal candidate will have a background in biomedical research, learning experience design, or instructional design, and a passion for designing content that fosters a dynamic and inclusive learning environment.. Masters degree or higher in a scientific field (e.g., Pharmacology, Biotechnology, Molecular Biology, Chemistry, or related discipline) and 2+ years of experience in science education.. OR bachelors degree in Instructional Design, Learning Experience Design, with demonstrated knowledge of scientific research and drug development (certificates, courses, or experience)
Lead cross-functional study execution teams across clinical operations, clinical science, biometrics, regulatory affairs, CMC, pharm/tox, drug safety, commercial, and alliance management. 8+ years of clinical ophthalmology research in the biopharmaceutical industry. Gene therapy experience strongly preferred. Experience contributing to NDA/BLA/MAA submissions. In-depth knowledge of ICH-GCP and FDA regulatory guidelines; international regulatory familiarity is a plus
Company Summary: A pre-IPO clinical stage biotech developing revolutionary therapies in the oncology & CNS spaces.. The Opportunity: Our client is seeking a seasoned physician with a strong clinical background and a passion for drug development to join our Clinical Development team where they will serve as the Senior Director, Clinical Research, Oncology.. Working closely with biomarker, discovery, and translational research scientists.. Collaborating closely with Clinical Science and other relevant functions and potential partners including discovery, translational, and biomarker research scientists, toxicologists, clinical pharmacologists, drug safety specialists, regulatory representatives, as well as personnel from Global Clinical Operations, and other support functions.. Working closely with functional partners (Data Management, Clinical Operations, Biostatistics, Regulatory) to ensure an integrated and strategic approach to flawless execution and systematic oversight of study protocol(s) in clinical development in close collaboration with key functional stakeholders.
The Director will be the Category Leader for the category assigned to them within the Strategic Sourcing and Procurement (SS&P) department.. This individual will be the key point of contact for their category and will be responsible for providing strategic leadership, operational oversight, and administrative/HR management for direct reports and extended leadership for indirect reports.. The Director, Sourcing will be a Category Leader for the Development Category encompassing Clinical Labs, Clinical Pharmacology, Translational Research, Global Patient Safety, Regulatory Affairs, Medical Affairs, Clinical Development, and Biometrics.. This role will support outsourcing needs to advance Exelixis R&D efforts, including services such as consulting, medical science liaison, pharmacovigilance, quality assurance, central labs, local lab results integration, PK and immunogenicity bioanalysis, biomarker assays, ADME studies, and toxicology.. Deep knowledge of outsourcing concepts, financial processes, contracts, regulations (FDA, EMA, ICH GCP), and industry standards.
In collaboration with UCSF Health operational and clinical leadership, and Quality and Safety (Q/S) leadership inclusive of CQO, Vice President, Executive Directors, and Medical Directors of Adult/Pediatric services, the Director participates in setting and implementing the annual strategic priorities for patient safety.. In partnership with operational leaders and key stakeholders, the Director develops strategic and operational plans to build a prospective, proactive, loss prevention, and harm reduction patient safety program that results in improved outcomes.. The Department of Quality & Safety consists of Adult Quality & Safety, Benioff Children's Hospitals (BCH) Quality & Safety, Hospital Epidemiology & Infection Prevention, Regulatory Affairs, Health Equity and Clinical Documentation Integrity.. Strong hospital management experience, with progressive and in-depth expertise in quality, safety and process improvement methodologies, statistical analysis, and database management. Consistently ranked among the top 10 hospitals nationwide by U.S. News & World Report - UCSF Health is committed to providing the most rewarding work experience while delivering the best care available anywhere.
Codexis is a leading enzyme engineering company leveraging its proprietary CodeEvolver technology platform to discover, develop and enhance novel, high-performance enzymes and other classes of proteins.. Come join us on this journey to transform the enzyme engineering landscape for the betterment of human health.. About the Opportunity: The Director of Quality Assurance is responsible for quality functions including disposition of enzymes, deviation resolution, CAPAs, change control, lab investigations, documentation supporting the suitability of the batches, completion of customer questionnaires, development/creation of quality systems and internal audits.. Provide QA leadership and collaborate with Supply Chain, Manufacturing, Quality Control, Analytical Development and Regulatory to ensure that internal operations achieve and maintain compliance with Codexis quality standards.. Technical experience or understanding in fermentation/DSP and quality control.
Under the general direction of the Vice President for Quality and Patient Safety, the Senior Director for Quality & Patient Safety at Saint Francis (SF) and St. Marys (SM) provides strategic leadership, planning, organization, and management for all aspects of the Quality & Patient Safety programs at these facilities.. Manage hospital epidemiology and infection control activities.. Enhance patient experience in collaboration with UCSF Health Division Director of Experience.. Manage quality and regulatory aspects of outpatient departments, including MACRA/MIPS, CLIA licenses, and other accreditation programs.. Experience with healthcare quality methodologies, data analysis, and hospital management systems.
Several Major Biotech companies are seeking Medical Director/Clinical Scientist with drug development experience to join the Oncology program.. The candidate should have an M.D. with board certification/eligibility in hematology/oncology,or a Phd,PharmD with at least 5 years of drug development experience.. Provide initial clinical designs for future trials including partnering with research, translational oncology, biostatistics, clinical operations, regulatory and pharmacology for input/alignment and presentation at the Therapeutic Development Team meetings. As Medical Monitor, to be responsible for all aspects of certain key clinical trials as per ICH/GCP guidelines. Perform regular clinical review of listings and partner with clinical operations/drug safety to develop a safety monitoring plan
The key functions of this role will be to collaborate with internal and external stakeholders including the Foster City Medical Affairs team, Scientific Publications, Medical Affairs Research, Marketing, Global Commercial Product Strategy, Value and Market Access, Clinical Research, Public Affairs, Government Affairs, Contracts/Finance, Pharmacology, Virology and Legal on both the global and regional levels.. Serve as Medical Affairs therapeutic area expert on Global Publications and Scientific Message Platform committees and other support for Scientific Communications. Oversee medical and scientific review of promotional materials for GRC and MRC. Must be fully cognizant and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities; thorough knowledge of FDA regulations, ICH guidelines and GCPs governing the conduct of clinical trials. Bachelor’s degree a minimum, but M.D., D.O., PhD (biological or pharmaceutical sciences), or PharmD preferred.
VahatiCor, a T45 Labs portfolio company, is seeking an Engineering Project Manager with a strong background in Mechanical or Biomedical Engineering to lead the development and manufacturing of Class II and Class III medical devices, focusing on catheter systems. The successful candidate will oversee cross-functional project execution from concept through commercialization, working closely with R&D, Quality, Regulatory, Clinical, and Manufacturing teams. Collaborate with Regulatory Affairs, Quality Assurance, Clinical Affairs, and Operations to ensure technical deliverables meet internal and external requirements. Bachelors degree in Mechanical Engineering, Biomedical Engineering, or related field; Masters degree preferred. Proficient in SolidWorks for mechanical design and drafting.
The Center for Cancer Cell Therapy (CCT) at Stanford University is seeking a Senior Regulatory Specialist to work with a strong team of regulatory experts responsible for the administration and regulatory compliance of clinical research within the university, and represent the university with external regulatory agencies, both domestic and international.. This position will support high-impact early phase clinical trials in the CCT group in a variety of cancer indications in both adult and pediatric patient populations.. The Senior Regulatory Specialist will work within in multidisciplinary teams of highly-skilled physicians, research scientists, cell manufacturing experts, and clinical research staff to conduct innovative early phase clinical trials according to Good Clinical Practice and all relevant institutional, state, and federal policies.. We strive for top-quality regulatory support of investigator-initiated clinical trials with a high degree of professionalism, initiative and flexibility.. We are looking for someone who already has a strong foundation in regulatory affairs and human subjects research, and/or specialized knowledge of working with cellular therapies.
Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.. PharmD/PhD with 2+ years’ relevant experience.. Significant regulatory, quality, compliance or related experience in the biopharma industry.. Significant experience participating in cross-functional projects and teams with responsibilities related to clinical trials or other drug development activities.. In-depth knowledge of current global and regional trends in biopharmaceutical regulatory affairs.