- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Director Clinical Data Management (CDM) serves as Therapeutic Area Head providing Clinical Data Management leadership to Data ... support of Regeneron key development programs. Works with Sr Director and Executive Director to set department...Manager (CCDM) experience. + Minimum of 12+ years of clinical data management experience in… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for ... Procedures (SOPs) within assigned program(s). The PDML is a member of the Clinical Data Management extended leadership team, and as such interacts with… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …and ensures scientific integrity and interpretation of study data of a clinical development program. The Director leads in a matrix environment as part ... The Director Clinical Sciences, Hematology, leads in... data review + Ensures consistent first line medical/ clinical data review techniques and conventions across… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Senior Director Clinical Development - Respiratory Date: Jan 21, 2025 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job ... role to support the growth within the respiratory clinical development program at Teva! The Senior Director... Development is responsible for the development, execution and management of several clinical programs worldwide across… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …operations, oversight of initiatives and trouble-shooting issues. Liaison for CS Physician and Data Management for study related safety reporting. Will also act ... and immune disorders. **Summary** This position works with the Director , Clinical Study Startup to establish the... Data Capture (EDC) Responsibility: In conjunction with Data Management , establish the EDC strategy at… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) review + Conducts clinical data review per Integrated Data Review Plan (IDRP) + ... ** Director , Clinical Development** **Join a Legacy...(MM): + Provides oversight to the CRO MM for clinical data review activities + May support… more
- System One (Basking Ridge, NJ)
- Director Clinical Safety 12 month contract Hourly Pay Max: $100- $120 (dependent on experience) Fully remote Description: The Director , Clinical Safety, ... , and provide safety leadership including but not limited to clinical studies, post-marketing surveillance, signal detection and management , important… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of ... together. **Job Description** We are seeking a strong, experienced Clinical Operations leader for a Director position...Leaders Forum providing key input into the leadership and management of the Clinical Operations Oncology Team,… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Join Gilead and help create possible, together. **Job Description** **Associate Director , Clinical Pharmacology - Virology** **_*This is a site-based ... cross-functional study team. + With input from others, designs clinical pharmacology study protocols, study data analysis,... pharmacology input into or otherwise authors study documentation, data analysis / management plans and scientific… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member...+ Study Strategy: Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC,… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …supplier management activities, and stakeholder engagement activities for the Clinical Laboratories Category as assigned. + Works independently to drive value in ... Accountabilities:** + Accountable for leading, defining, and implementing the global Clinical Laboratories Category strategy to serve global and regional business… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Sr Director , Global Regulatory Medical Writing & Data Transparency Date: Dec 28, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva ... and new people to make a difference with. **The opportunity** The Senior Director in Global Regulatory Medical Writing & Data Transparency provides leadership,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …of safety data between partners in relation to marketed and clinical products. **Strategic Partner Management :** Oversees Local/Global PV service providers ... around rare diseases and immune disorders. **Summary** Leads the development and management of DSI's local and global Strategic PV Partnerships and contracts… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Gilead and help create possible, together. **Job Description** **POSITION OVERVIEW: Director , Biostatistics** Position can be REMOTE or office based in Parsippany, ... and your direct reports will collaborate with cross-functional partners to meet clinical development project deliverables and timelines. This may include, but is not… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …of data to ensure quality of results. **Service Provider Oversight & Management ** + Oversight of Data Request processing by Service Providers + Training ... + Has a comprehensive understanding of the functional roles within Pharmacovigilance and Clinical Trials + Ability to extract configurable data fields from a… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …accountable for driving the integration and peak performance of R&D's Quality Management System, across Clinical Development and Post-Marketing, supporting the ... Quality System Elements and includes the Audit, Deviation, CAPA, Risk Management , Escalation/Serious Breach, and Quality Analytics/ Data Science programs PRIMARY… more
- Sanofi Group (Morristown, NJ)
- …guidance to internal Sanofi customers, including contribution of medical information and clinical trial data for pharmacovigilance (PV) and regulatory reports to ... **Job Title:** US Medical Director , Mainline Vaccines **Location** : Bridgewater, NJ /...label updates and product Company Core Datasheet (CCDS) updates. ** Data Generation** + Work with R&D and Clinical… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …Relationship Management & Penetration + Partner with each Associate Director in the identification and penetration of key stakeholders including decision making ... Director Medicaid - Remote Date: Dec 27, 2024...Preferred Drug List (PDL) access, pull through and resource management for Medicaid business + Work collaboratively across the… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. **Summary** The Associate Director of Regulatory Writing is a key role responsible for producing ... scientifically accurate, high-quality clinical regulatory documents while adhering to regulatory guidelines. This...strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …and timelines. Driving Impactful Research, Data Analysis, and Presentation + Data Insight and Protocol Development: Oversee clinical and biomarker data ... Director , Translational Science Lead - Immunology (Parsippany, NJ...to drive innovation in immunology? Teva's R&D Global Early Clinical Development is expanding and seeks a passionate **Translational… more