- ORIC Pharmaceuticals, Inc. (San Diego, CA)
- …position involves working closely with cross-functional colleagues including regulatory operations , quality, CMC, nonclinical and clinical team members. S/he ... development, GMP Quality Assurance, in addition to Project Management, Clinical Operations , Clinical Supply, and Regulatory Operations .Lead… more
- ORIC Pharmaceuticals, Inc. (San Diego, CA)
- …This involves working closely with cross-functional colleagues including regulatory operations , quality, CMC, nonclinical and clinical team members. S/he ... and collaborate regulatory activities across functions within ORIC, ie, regulatory operations , quality, CMC, nonclinical, clinical .Responsible for the… more
- Scismic (Boston, MA)
- …provide regulatory expertise for product development including the areas of clinical research, CMC, regulatory operations , nonclinical study requirements ... that is discovering and developing novel medicines for cancer.We are seeking an Associate Director / Director of Regulatory Affairs to join the company. This… more
- Vir Biotechnology, Inc. (San Francisco, CA)
- …regulatory requirements. Ensure compliance with internal SOP's and policies regarding regulatory operations , document management. Contribute to regulatory ... is seeking a highly motivated, self-driven and enthusiastic Senior Director of Regulatory CMC accountable for ensuring...accountable for ensuring all assigned products have a successful regulatory CMC strategy for clinical development and… more
- OM1 (Boston, MA)
- …product management and research.Have a robust understanding of healthcare departmental/ clinical operations , workflow, policies, and procedures. Regulatory ... us to generate unique insights in a variety of disease areas.The Director , Clinical Project Management works cross-functionally with the Epidemiology,… more
- Stanford Children's Health | Lucile Packard Children's… (Palo Alto, CA)
- …Children's Health (SMCH) primary market sites. Directs the strategy and implementation of clinical operations across the primary market sites and ensures that ... general nature, level and purpose of the job.The Executive Director of Ambulatory Operations will focus on...focus on leading the development and implementation of standardized clinical and regulatory workflows across all ambulatory… more
- Lucile Packard Children's Hospital (Palo Alto, CA)
- …Children's Health (SMCH) primary market sites. Directs the strategy and implementation of clinical operations across the primary market sites and ensures that ... and family at a time. Job Summary The Executive Director of Ambulatory Operations will focus on...focus on leading the development and implementation of standardized clinical and regulatory workflows across all ambulatory… more
- ReCode Therapeutics, Inc. (Menlo Park, CA)
- …in driving the nonclinical and translational sciences strategy, ensuring alignment with clinical development plans, and navigating regulatory pathways to support ... leader to join ReCode Therapeutics as the Head of Translational Sciences & Nonclinical Operations . In this role, you will report into our SVP of Early Development… more
- San Francisco (San Francisco, CA)
- …and severe hypertriglyceridemia (SHTG). THE ROLE Reporting to the Vice President, CMC Operations , the Head of/Senior Director CMC Operations (Drug Substance) ... THE COMPANY 89bio is a clinical -stage biopharmaceutical company focused on the development and...and data trending analysis. Write and review documents for INDs/ regulatory submissions as a technical SME to support … more
- Kyverna Therapeutics, Inc. (Emeryville, CA)
- …collection centers according to program plans and strategy.In close collaboration with Clinical Operations and Technical Operations , define the requirements ... Kyverna Therapeutics is a clinical -stage cell therapy company with the mission of...diseases are treated.Kyverna is recruiting a highly motivated Associate Director , Patient Operations - Quality Assurance in… more
- Cresco Labs (Chicago, IL)
- …on regulatory compliance, product consistency, and customer satisfaction. Our operations bring legitimacy to the cannabis industry by acting with the highest ... of integrity, strictly adhering to regulations, and promoting the clinical efficacy of cannabis. As Cresco grows, we will...into.JOB SUMMARYReporting to the President of the region, the Director of Sales and Operations Planning is… more
- KARL STORZ SE & Co. KG (El Segundo, CA)
- …& Regulatory AffairsLocation: El Segundo, CA, US, 90245The Medical Director , Medical Affairs will have broad responsibility for supporting multidisciplinary and ... cross-functional teams with relevant clinical information. The Medical Director will lead...teams working across the lifecycle of KARL STORZ products.Provide clinical use scenarios for development and regulatory … more
- KARL STORZ SE & Co. KG (El Segundo, CA)
- … Director , US Medical AffairsJob Function: Patient Health & Regulatory AffairsLocation: El Segundo, CA, US, 90245Work Flexibility: RemotePay Range: $170,700 ... R&D, Regulatory , Commercial, Legal, and Compliance teams to ensure clinical decisions align with company strategy.Strategic Collaboration: Work with US MSA… more
- Xilio Therapeutics (Waltham, MA)
- …the VP, Regulatory Affairs and Quality will be responsible for hiring a Director , Regulatory Operations , to report to them. Job Responsibilities: ... and adopt regulatory strategies in a timely manner. Regulatory operations leadership Hires, leads and coaches the Director , Regulator Operations ,… more
- Neogene Therapeutics (Santa Monica, CA)
- …years of experience in supply chain management, with a focus on clinical operations in the biopharmaceutical industry.Experience managing supply chains for ... SummaryWe are looking for an experienced and strategic Senior Director of Clinical Site Supply Chain to... Site Supply Chain to lead and improve our clinical site supply chain operations in a… more
- University of California San Francisco (San Francisco, CA)
- …programs, policies, and patient care service standards, and ensures compliance with regulatory agencies. The Director will collaborate closely with ambulatory ... responsibility for the program development, management, and overall day-to-day business operations .The Director collaborates with Medical Director , Surgical… more
- Brigham and Women's Hospital (Boston, MA)
- … requirements on an ongoing basis.Key ResponsibilitiesManage CMS assessment operations , competencies, and regulatory compliance.Hire, train, support, and ... Job Description - Director , Post Acute Assessments (3303240)Job SummaryThe CMS Assessment...AANAC, UDS, EREHAB).Minimum of 5 years experience in either clinical nursing or case management.Knowledge of post-acute regulatory… more
- Indapta Therapeutics Inc. (San Francisco, CA)
- … trials. Responsibilities will include: Lead the CMC QA function and partner with clinical , regulatory and CMC teams, including contracted CDMOs to ensure the ... About Us: Indapta is a clinical stage biotechnology company harnessing the natural power...seeks an experienced, biotech CMC quality professional at a director or senior director level. We offer… more
- Genmab A/S (Princeton, NJ)
- …medical review, and medical expertise advice as required.Collaborate with medical and clinical operations departments to coordinate the planning, execution, and ... the hosting of this site please contact us at ###@Genmab.com. Director , Global Medical Affairs Strategy - Solid TumorsLocation: Princeton,...management of clinical trial activities across medical affairs functions.Contribute to effective… more
- Genmab (Princeton, NJ)
- …review, and medical expertise advice as required. Collaborate with medical and clinical operations departments to coordinate the planning, execution, and ... to the Global Medical Affairs Strategy Lead (MASL), the Director will be responsible for the development and execution...management of clinical trial activities across medical affairs functions. Contribute to… more
