- Insmed Incorporated (NJ)
- …one compound to ensure all are delivered on time, within budget and with high quality . This role may manage clinical operations team members, as delegated by ... an 1-2 indications within one compound, in collaboration with the Senior Director , Clinical Operations. Ensures consistent and successful execution of… more
- Formation Bio (New York, NY)
- …to bring new treatments to patients faster and more efficiently.About the PositionThe Director of Clinical Project Management will provide overall leadership and ... deliverables, including overall timelines, budget forecasts, and resource allocation. Ensure all clinical trials comply with ICH- GCP , FDA regulations, and other… more
- Sanofi (Cambridge, MA)
- Job Title: Senior Clinical Research Director Location: Cambridge, MA or Morristown, NJ About the Job Join the engine of Sanofi's mission - where deep ... the impossible into possible for millions. As the Senior Clinical Research Director (Senior CRD) within the...the clinical trials in compliance with Good Clinical Practice ( GCP ), applicable laws and regulations… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Leaders/National Expert Panels for select clinical trials, in collaboration with Clinical Director and Clinical Operations lead Support investigator ... Clinical Trial Strategy Team in collaboration with Clinical Operations point, Clinical Director ,... trials and with other MA tools (expertise in clinical trial methodology and conduct, GCP principles,… more
- Sanofi (Morristown, NJ)
- …The Development Scientific Director (DSD) is a responsible member of the clinical team dedicated to the development and execution of clinical strategies and ... compound program. The primary purpose of the development scientific director 's position is to support the Clinical ... clinical development plans and trial set-up to clinical study report in compliance with quality … more
- Merck & Co. (Rahway, NJ)
- …clinical data/medical protocol deviations in collaborations with the Clinical Director .Other responsibilities include:Collaborating cross-functionally in the ... protocol in collaboration with Data Management/Programming.Collaborating cross-functionally to monitor clinical data to ensure quality , completeness, and… more
- Takeda Pharmaceuticals (Boston, MA)
- …of my knowledge. **Job Description** **ABOUT THE ROLE** The Associate Director , GCP Audit & Compliance provides strategic quality oversight to clinical , ... supplier oversight, and strategic risk management to enhance end-to-end clinical quality . **HOW YOU CONTRIBUTE** + Lead...(or equivalent). + Minimum 15+ years of experience in GCP /GCLP/GVP Quality or Compliance within the pharmaceutical… more
- Actalent (Paramus, NJ)
- Job Title: GCP Auditor/Senior Auditor, Quality Assurance The GCP Quality Assurance Auditor/Senior Auditor will play a crucial role in ensuring compliance ... audits and provide day-to-day support to the GXP QA Director in clinical operations, non- clinical ,...clinical related regulations and guidelines. + Collaborate with clinical sourcing, supplier quality , and clinical… more
- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** **About the role:** The Associate Director , Clinical & Quality Process Compliance is responsible for ... teams for regulations impacting Clinical , Safety and Clinical Pharmacovigilance Medical Quality (CPMQ) processes and...Statistics, with at least 3 years of experience in GCP Quality /Compliance. + Advanced knowledge of pharmaceutical… more
- Morehouse School Of Medicine (Atlanta, GA)
- Clinical Trials Operations (CTO) Director - Clinical & Operational Implementation Bookmark this Posting Print Preview | Apply for this Job Please see Special ... will find a fulfilling career at MSM ! Posting Number NONAC3673 Job Title Clinical Trials Operations (CTO) Director - Clinical & Operational Implementation… more
- University of Pennsylvania (Philadelphia, PA)
- …of health and wellness programs and resources, and much more. Posted Job Title Director , Clinical Research Operations Job Profile Title Director , Clinical ... Research Operations Job Description Summary The Director , Clinical Research Operations will report to the Director... will ensure that Standard Operating Procedures (SOPs), Good Clinical Practices ( GCP ), regulatory guidelines, and all… more
- BeOne Medicines (San Mateo, CA)
- …years of relevant experience. + Relevant experience can be in drug development, clinical operations, clinical quality assurance, medical affairs, clinical ... **General Description:** The Director , Global Clinical Operations, Compliance builds,...the business and drive the compliance activities within Global Clinical Operations. Provides quality guidance, direction and… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …least 5 years of Quality /Compliance experience. + Advanced knowledge of clinical research ( GCP ), pharmacovigilance (GVP) and medical throughout R&D and ... ready with a culture of sustainable compliance. Represents Takeda as a clinical quality subject matter expert during health authority inspections of the sponsor.… more
- Beth Israel Lahey Health (Boston, MA)
- …and advocating for the health of patients, families, and communities. The Nursing Director for the Cancer Clinical Trials Office (CCTO) reports directly to ... nursing staff and coordinates nursing coverage for trials, including directly working on clinical trials. The Nursing Director is responsible for working with… more
- Takeda Pharmaceuticals (Boston, MA)
- …company to inspire you and empower you to shine? Join us as a Director , Clinical Operations, Oncology based remotely reporting to the Executive Director ... Operations leadership under the direction of the Senior Director , Clinical Operations: + Accountable for the...+ Accountable for the overall execution of the assigned clinical program(s) with focus on quality , budget… more
- Otsuka America Pharmaceutical Inc. (Santa Fe, NM)
- …oversight of clinical research programs and protocols for OPDC products under good clinical practices ( GCP ). The Senior Director , GCD works in a ... Provide medical and scientific leadership to cross-functional study teams and ensure high- quality clinical trial design, conduct, and data interpretation. +… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …implements data management strategies, processes, and standards in alignment with Good Clinical Practices ( GCP ) and applicable regulatory guidelines (eg, FDA, ... to CROs ensuring adherence to cost, timeline, and data quality requirements. * Participates in clinical vendor...In-depth knowledge of CDM processes, regulatory standards (FDA, EMA, ICH- GCP ), and clinical data standards (eg, CDISC,… more
- ThermoFisher Scientific (Las Vegas, NV)
- …drug screening. Due to continued growth, we are looking to appoint an Associate Medical Director at the Las Vegas Clinical Research Unit. This role is an ... the protocol is being conducted under all applicable laws, regulations and per ICH- GCP guidelines in the organization's Clinical Research Unit (CRU). Consults… more
- Organon & Co. (Plymouth Meeting, PA)
- …the scientific and data integrity, rigor and quality thereof. The director may represent the Clinical Pharmacology function in asset development teams ... **Job Description** **The** **Position** The Director , Clinical Pharmacology Lead will be... development guidance, as appropriate. + Working knowledge of GCP , ICH and other regulatory standards. + Ability to… more
- Amgen (Thousand Oaks, CA)
- …us and transform the lives of patients while transforming your career. **Executive Director , Clinical Development, Rare Disease** **Live** **What you will do** ... aspects of clinical drug development across Amgen's clinical programs. This Executive Director within ...pre- clinical toxicology approaches + Knowledge of Good Clinical Practices ( GCP ), FDA regulations and guidelines,… more
