- Taiho Oncology (Princeton, NJ)
- … operations practices and processes ensuring consistent delivery across studies . Education/Certification Requirements: + Associate 's degree or equivalent. ... impactful results. The leadership and support provided by our Clinical Operations team are the cornerstone of...dynamic team cultivating growth and learning. Position Summary: The Study Associate (SA) I is responsible for… more
- Sumitomo Pharma (Trenton, NJ)
- …Trial Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director, Clinical Business Operations , the specialist ensures ... and system work instructions. Provide support and guidance to study team members during the full lifecycle of the...ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure… more
- Parexel (Trenton, NJ)
- …or Director of Site Management and Monitoring (DSMM) + Partners with SCP and Country Study Operations Manager (SOM) + When required Partners with other Study ... **Job Purpose:** The Senior Clinical Research Associate (Sr. CRA) is...Demonstrated knowledge in disease and technical areas pertaining to clinical studies , including knowledge of company direction,… more
- Bristol Myers Squibb (Princeton, NJ)
- …aspects of study design. + In collaboration with Medical Writing and Clinical Operations , prepares study protocols, amendments, specific sections of ... to, collaboration on functional area activities during program implementation, clinical study start-up/execution/close out, data analysis/reporting, and… more
- Sumitomo Pharma (Trenton, NJ)
- …director is responsible for the leadership, development, and management of clinical studies while building and maintaining relationships with investigators ... highly motivated, and experienced individual for the position of ** Associate ** **Medical Director, Clinical Development - Oncology**...and study staff. + Responsible for leading clinical study teams, monitoring overall study… more
- Bristol Myers Squibb (Princeton, NJ)
- …expert on all information regarding the global use of investigational material in clinical studies **Key Responsibilities:** + Provides strategic direction for ... and in their personal lives. Read more: careers.bms.com/working-with-us . The ** Associate Director, Clinical Supply Program Leader** strategizes direction for… more
- Bristol Myers Squibb (Princeton, NJ)
- …analytics. This is an ideal opportunity for professionals with backgrounds in consulting, clinical operations , or trial analytics who are ready to take ownership ... of delivery and help shape the success of global studies . **Key Responsibilities** + Own study -level analytics...scoring, and performance dashboards + Engage directly with cross-functional study team members ( clinical , feasibility, ops, TA… more
- AbbVie (Florham Park, NJ)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director, Statistics provides statistical leadership for clinical ... of methodologies for confounding control and bias minimization in observational studies preferred. Key Stakeholders Clinical development experts Statistical… more
- AbbVie (Florham Park, NJ)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director, Statistics - Immunology provides statistical leadership for ... clinical development and life-cycle management strategies for assigned projects....trials, patient safety, and global medical affairs (GMA). The Associate Director works in partnership with experts in multiple… more
- Sumitomo Pharma (Trenton, NJ)
- …relationships with colleagues, fostering collaboration, and idea sharing + Reviews nonclinical, clinical and CMC documentation (eg nonclinical study reports, ... general product development in the pharmaceutical industry + Experience reviewing nonclinical, clinical and CMC documentation (eg nonclinical study reports, … more
- Bristol Myers Squibb (Princeton, NJ)
- …Ensures compliance with Good Laboratory Practice, Standard Operating Procedures, and study protocols in conducting nonclinical studies , when applicable. Ensures ... + Assists in the proper design and timely reporting of toxicity studies (GLP/nonGLP), including single- and repeat-dose toxicity, investigative toxicity, and other… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …maintain the effectiveness of the Otsuka Quality Systems that support OPDC-sponsored clinical studies as well as drive continuous improvement. **Job ... release process for OAPI GMP release of Contract Manufacturers operations supporting clinical and commercial products. +...escalation of any situations with potential negative impacts on clinical study supplies, supply chain for commercial… more
- Ascendis Pharma (Princeton, NJ)
- …groups. + Work with internal stakeholders including Commercial, Legal, Regulatory, Clinical Development, Clinical Operations , Compliance, Pharmacovigilance, ... member of the Endocrine Medical Sciences team for the US business, the Associate Medical Director supports the US Medical Director for deliverables and activities… more
- ThermoFisher Scientific (Bridgewater, NJ)
- …Office **Job Description** PPD is revolutionizing patient recruitment. As the clinical research division of Thermo Fisher Scientific, PPD has launched Patient ... enabled solutions, Patient First optimizes patient recruitment and engagement, site operations , and quality data collection. Step into a high-impact role where… more
- Sanofi Group (Morristown, NJ)
- …ISO standards (13485, 15189), CLIA accreditation, lab developed test, and clinical performance studies .Ability to synthesize and critically analyze data ... **Job Title:** GRA Device Associate **Location:** Cambridge, MA/ Morristown, NJ/ Washington DC...Our department bridges the gap between technical development, manufacturing operations , and global regulatory authorities to ensure compliance while… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …maintain the effectiveness of the Otsuka Quality Systems that support OPDC-sponsored clinical studies as well as drive continuous improvement. **Job ... **Job Summary** The Associate Director Controlled Substances, Quality Global Product Quality...process for + OAPI GMP release of Contract Manufacturers operations supporting clinical and commercial products. +… more
- Bristol Myers Squibb (Princeton, NJ)
- …to lead structured benefit-risk assessments for assigned assets from early clinical development through late-stage and post-marketing. This role requires close ... relevant departments across the organization, including medical safety assessment, clinical development, global regulatory, epidemiology and others. The SBRA Lead… more
- GRAIL (Trenton, NJ)
- …and we are using the power of next-generation sequencing (NGS), population-scale clinical studies , and state-of-the-art computer science and data science to ... relevant documentation. The role collaborates cross-functionally with Quality, Lab Operations , and other stakeholders to support regulatory strategy development,… more
- BeOne Medicines (Pennington, NJ)
- …root cause analysis, and risk management. + Experience with tech transfer to clinical /commercial manufacturing facilities. + Knowledge of study design such as ... and authoring of various reports. This position reports directly into the Associate Director, Manufacturing Science and Technology (MST) Cell Culture and is located… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …and collaborate with PS Therapeutic Area leads in combination product development and clinical studies . + Collaborate with cross-functional team in device risk ... seeking a dynamic and experienced individual to join the **Patient Safety Strategic Operations ** team as an ** Associate Director, Patient Safety Medical Device… more