- Daiichi Sankyo, Inc. (Bernards, 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...Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population… more
- Bristol Myers Squibb (Summit, NJ)
- …personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Senior Director of Clinical Quality Audit strategy is responsible ... of critical quality risks and issues that may affect BMS. The Senior Director , Clinical Quality Audit strategy is also responsible for effectively… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- Job Title Senior Director , Clinical Development & Medical Affairs (CDMA) Requisition JR000014103 Senior Director , Clinical Development & Medical ... NJ Additional Locations Job Description Summary Job Description The Senior Director , Clinical Development Medical...we contribute to something that matters because we make quality products that impact patient lives. Our dynamic work… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Senior Director Clinical Development... results and provide a guidance to prepare high quality reports working with Medical Writing + Working with ... within the respiratory clinical development program at Teva! The Senior Director , Clinical Development is responsible for the development, execution and… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Senior Director Clinical Development - Psychiatry Date: Jan 28, 2025 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job ... people to make a difference with. **The opportunity** The Senior Director of Clinical Development...CRO engagement. + Proactively identify and mitigate risks across clinical programs, ensuring quality and compliance with… more
- J&J Family of Companies (Raritan, NJ)
- …interactions may include project management, finance, legal, quality assurance, quality monitoring & compliance, clinical supplies unit, TA strategy, ... agencies + Supervising and contributing to the timely completion and quality of clinical study reports, including providing key input to statistical analysis… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …projects through early and late phase development. The Director reports to the Senior Director Clinical Sciences and collaborates closely with Medical ... The Director Clinical Sciences, Hematology, leads in...and independently supports the development of regulatory documents; performs quality review and/or approval; adjudicates and resolve cross functional… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …and assuring effectiveness in delivery on quality objectives and a strong quality voice. Additionally, the Senior Director will collaborate closely with ... by advancing the care of patients with life-threatening diseases. ** Senior Director , GVP** **Audits** The Senior...for driving the integration and peak performance of R&D's Quality Management System, across Clinical Development and… more
- J&J Family of Companies (Raritan, NJ)
- …a people manager position within the Delivery unit and is accountable to the Senior Director of Clinical & Statistical Programming for assigned activities ... Johnson & Johnson is currently seeking a Clinical Programming Director to join our...Area Stronghold Leader: + Accountable for the operational delivery, quality , and compliance of the assigned portfolio across one… more
- System One (Florham Park, NJ)
- …of 8 -10 years ( Director ) or, minimum 10-12 years ( Senior Director ) of experience in medical operations, clinical operations, or a related field within ... Job Title: Director / Senior Director , Medical Operational...clinical operations, regulatory affairs, commercial and marketing, and quality assurance, to drive alignment and achieve operational goals.… 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 ... help create possible, together. **Job Description** We are seeking a strong, experienced Clinical Operations leader for a Director position within our Oncology… more
- J&J Family of Companies (Raritan, NJ)
- …and profoundly impact health for humanity. Learn more at https://www.jnj.com/. The Senior Director , Compound Development Team Leader will lead cross-functional ... our early development strategies to advance our assets to clinical proof of concept in alignment with our Ophthalmology...to assess whether the asset can meet target product profile/ quality standards + In partnership with Late Development and… more
- Matheny Medical and Educational Center (Peapack, NJ)
- Senior Director of Information Services EOE...mission is to provide exceptional care and an optimal quality of life for children and adults with special ... Matheny Medical and Educational Center has a career opportunity available for aFull Time Senior Director of Information Services. Our Core Values: + Respect +… more
- Sanofi Group (Bridgewater, NJ)
- …for patients and their families. Join our **Biostatistics Rare Diseases as Senior Statistical Project Leader ( Director )** and you'll provide statistical ... leadership, guidance, and strategic input for clinical studies in one or more project teams. You'll...with other statistics project leaders, and in communicating with senior leadership. + Mentor junior project team members and… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …with senior level management, external vendors, collaboration partners and clinical study personnel for clinical research project and department initiatives. ... is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is responsible for data management… 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...Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan; Reviews patient population… more
- Sanofi Group (Bridgewater, NJ)
- **Job Title** : Senior Director , Global Advertising and Promotion Therapeutic Area Head **Location:** Bridgewater, NJ / Cambridge, MA (must adhere to hybrid ... strategies (eg, submissions, product defense, labeling development, FDA enforcement, clinical trial support, FDA contacts). + Provide opportunities for direct… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …short- and long-term goals, lead the MR group to deliver timely and high- quality medical review, ensure the MR process and procedure in alignment with regulatory ... in Patient Safety cross-functional teams. + Communicates to highest levels of senior management key pharmacovigilance findings. + Oversees or performs medical review… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …statistical support to clinical studies or programs with the guidance of senior level statisticians (ie, Associate Director or higher) which includes, but is ... Senior Manager Clinical Statistician Date: Jan...for budget planning. + Manage and Deliver assignments with quality and within timelines. + Possible to have direct… more
- Bristol Myers Squibb (Madison, NJ)
- …feedback. + Build a collaborative, supportive learning environment and ensure high- quality delivery of pharmacovigilance activities. + Ensure timely information is ... and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability,… more
