- Sumitomo Pharma (Honolulu, HI)
- …of clinical trial methodology, regulatory and compliance requirements governing clinical trials , and experience in development of clinical strategy ... dynamic, highly motivated, and experienced individual for the position of **Medical Director , Clinical Development - Oncology** . The medical director is… more
- Sumitomo Pharma (Honolulu, HI)
- …global clinical trials in both early- and late-stage clinical development, especially protocol development and trial initiation + Experience in ... within the Ophthalmology therapeutic area + Provides oversight of clinical trial conduct, interacting with CROs, medical...findings + Serve as the internal medical monitoring for clinical trials + Review and provide input… more
- Otsuka America Pharmaceutical Inc. (Honolulu, HI)
- …stages to post commercialization, with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director , GCD is responsible ... major impact on human health. OPDC develops promising drug candidates, starting with clinical trial management, and then planning the strategy for drug approval,… more
- Norstella (Honolulu, HI)
- …and forecasting + Protocol Design, Country, Site and Investigator Feasibility + Clinical trials operations, cost benchmarking & landscapes + Performance ... Sr. Director /VP/ Clinical Delivery Lead, Advisory Services Company:...+ Deep knowledge and expertise of the pharma strategic Clinical trial landscape (Clin Dev/Ops, clinical… more
- Otsuka America Pharmaceutical Inc. (Honolulu, HI)
- …Leaders, Patient advocacy leaders, health authorities) + Support interpretation of key clinical trial results, regulatory feedback and other relevant information ... treatment ecosystems. **Job Description** The specific duties assigned to the Executive Director ; Global Clinical Development Program Lead will include the… more
- Hawaii Pacific Health (Honolulu, HI)
- …by our highly trained professional staff of care providers and research managers. As the Clinical Trials Director , you will have the opportunity to build our ... of health prevention in Hawai'i. HPHRI researchers conduct more than 200 clinical trials within the Hawai'i Pacific Health network of hospitals - Kapi'olani… more
- Otsuka America Pharmaceutical Inc. (Honolulu, HI)
- …providers (ESPs), etc.). Responsibilities include the planning, execution and completion of clinical trials according to applicable regulations and guidance; ICH ... studies at Otsuka, including planning, execution, and completion of clinical trials according to all applicable regulations...(s), as assigned. * Participates in ongoing review of clinical trial data focusing on data integrity,… more
- Parexel (Honolulu, HI)
- …is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study ... and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (eg enrollment, database release), to safeguard the… more
- Sumitomo Pharma (Honolulu, HI)
- …International Council for Harmonization E6(R2). + Fundamental knowledge of the conduct of clinical trials is preferred. + Strong focus on teamwork, attention to ... Files (TMFs) ready for audits and inspections. Partnering with the Associate Director , Clinical Business Operations, the specialist ensures accountable functions… more
- Parexel (Honolulu, HI)
- …for seasoned Project Management professionals with a strong background running global clinical trials in a variety of therapeutics. This group focuses ... part of driving success for our clients and advancing clinical research projects. As a part of the Global...with at minimum, 2+ years' experience leading Global Clinal Trials in Project Management within a CRO (preferred), Biotech… more
- Parexel (Honolulu, HI)
- …to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. + Good ... associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of… more
- Otsuka America Pharmaceutical Inc. (Honolulu, HI)
- …in the development of protocols and statistical designs in different phases of the clinical trials leading to approval of drug products in different phases of ... the clinical trials . This position can be based...member, provide statistical input in different perspective of the clinical trial conduct such as CRF review,… more
- Parexel (Honolulu, HI)
- …treatments for patients worldwide. **What You'll Do** **Lead Medical Excellence in Clinical Trials ** + Serve as **Medical Monitor** for gastroenterology studies, ... **Medical Director - Gastroenterology Specialty** **Location:** Remote - United...patient safety + Provide expert medical oversight throughout the clinical trial lifecycle-from protocol development through study… more
- Merck (Honolulu, HI)
- …and retention efforts to achieve study milestones + Upon request from Global Clinical Trial Operations (GCTO), + Recommends study sites and identifies potential ... publication \#eligibleforERP **Required Skills:** Cardiovascular and Metabolic Disease (CVMD), Clinical Trials , External Collaboration, Medical Affairs, Metabolism,… more
- Parexel (Honolulu, HI)
- …clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our ... Empowerment & Accountability. **Parexel is looking for a Medical Director with a very strong background in Ophthalmology to...Experience as a Physician in Industry or as a clinical trial investigator is required + Previous… more
- Sumitomo Pharma (Honolulu, HI)
- …regulatory submissions and working with regulatory templates + Understanding of EU Clinical Trial Regulation and ROW country regulatory requirements related to ... motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director ... clinical trials The base salary range for… more
- Merck (Honolulu, HI)
- …remotely; candidate should reside within the coverage region. \#eligibleforERP **Required Skills:** Clinical Research, Clinical Trials , HIV AIDS, Infectious ... **Job Description** The Virology (HIV) Regional Medical Scientific Director is a credentialed (ie, MD, PhD, DNP, or PharmD) therapeutic and disease area expert who… more
- Otsuka America Pharmaceutical Inc. (Honolulu, HI)
- …research priorities and providing expert input into the design and feasibility of clinical trials and data generation initiatives + Support the planning and ... The Medical Director , Rheumatology and/or Dermatology Medical Strategy is a...development plans ensuring scientific consistency and alignment across R&D, Clinical , Global Medical Affairs, and Early Commercialization functions +… more
- Otsuka America Pharmaceutical Inc. (Honolulu, HI)
- …Asset engagement must focus on obtaining input from KOLs and Payers on trial design and clinical /economic value). **System and Data Management** + Coordinate ... The Director , External Expert Strategy & Engagement is a...with stakeholder engagement liaisons (from GMA, Commercial, Clinical Development, Market Access, Patient Advocacy and Stakeholder Management,… more
- Merck (Honolulu, HI)
- …demonstrated record of scientific/medical publication \#eligibleforERP **Required Skills:** Clinical Trial Support, Healthcare Education, Medical Affairs, ... **Job Description** **Role Summary** + The Regional Medical Scientific Senior Director Team Lead, RMSD TL, is a credentialed (ie, MD, PhD, PharmD, DO, and OD)… more