- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.SummaryThis position serves as the Clinical Safety Scientist Lead for a large, late-stage program or ... safety surveillance and risk management in partnership with Product Safety Lead(s), Clinical Safety Physician(s), and cross-functional team in support of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. SummaryThis position supports safety monitoring and risk management activities, provides insights on current ... clinical practice and guidelines, reviews and provides written assessments...position supports a senior physician in evaluating and mitigating safety signals as they arise. Additionally, this position works… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an equal opportunity employer including veterans and people with disabilities. SummaryThe Associate Director , Global Oncology Clinical Development (GOCD) ... generation (checklist, process map, etc.), change management and detailed analyses. The Associate Director , GOCD Functional Excellence must have excellent verbal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …business function and collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise wherever necessary. Ensure requirements are in place ... around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the...(global/ local), and not limited to: Global Project Team, Safety Management Team, Clinical Safety … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core ... Data Sheets (CCDS) for assigned products. This position drives/leads the maintenance of global labeling and associated documents (including cartons and external packaging in the US) for assigned Daiichi Sankyo products. This position ensures that draft… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Manager role is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in...writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND.Lead the CRO and vendor selection… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … safety information for all Novo Nordisk products. Relationships Reports to Associate Director , Patient Safety Training. Internal relationships include ... Safety database systems and reporting tools, SOPs, NNI-GS Agreements, FDA safety reporting guidelines and Good Clinical Practice (GCP) to ensure… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Clinical Operations Pleasanton, CA, USA * Princeton, NJ, USA Req #367 Friday, June 28, 2024 Looking for a chance to make a meaningful ... and manages multiple complex global studies to support the Clinical Development Plan. The Associate Director...procedures and oversees the quality of the data and safety of the patients. Communicates deviations from the protocol,… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , PV Sciences Pleasanton, CA, USA * Princeton, NJ, USA Req #361 Friday, June 28, 2024 Looking for a chance to make a meaningful difference in ... Value Proposition: Embark on a transformative journey with Taiho Oncology as an Associate Director in PV Sciences. At the forefront of pharmacovigilance… more
- Bristol Myers Squibb (Princeton, NJ)
- …data generation, insight generation and patients' access to medicine. The Regional Associate Director (RAD) role is field-based and focused on managing ... support of BMS medicines and all phases of associated clinical trials. The RAD oversees their regional team to...timelines + Contributes to managing external communication when significant safety issues arise, with the well-being of patients being… more
- Bristol Myers Squibb (Princeton, NJ)
- …every treatment we pioneer. Join us and make a difference. **Purpose** The Associate Director , Biostatistics is a core member of cross-functional development ... the development and execution of statistical aspects for one or more clinical trials, including contribution to study trial design, analysis planning, study results… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be responsible for ... and executes a labeling implementation plan to incorporate new scientific, safety and clinical data, as well as Health Authority responses / feedback into… more
- Bristol Myers Squibb (Princeton, NJ)
- …efforts. QSP modeling has become an important component of discovery and clinical development. QSP models are mechanistic, mathematical models, based on integration ... of non- clinical / clinical knowledge and data to represent varying...engagement, and enhances the Company culture. To protect the safety of our workforce, customers, patients and communities, the… more
- BeiGene (Hopewell, NJ)
- …ensuring the successful day to day management of: Batch Release (both clinical and commercial), QA manufacturing shop floor activities, Batch Release Key Performance ... compliance with FDA/EU regulation, covering cGMP for commercial medicinal products and clinical material for human use. + Significant participation in regulatory and… more
- Merck (North Wales, PA)
- …manufacturing to manage clinical development projects; and + Assist the Senior Director , Executive Director , and/or Associate Vice President in ensuring ... talented and dedicated colleagues while developing and expanding your career. The Clinical Director (Principal Scientist) has primary responsibility for the… more
- Merck (West Point, PA)
- …Our Company is seeking a highly motivated candidate for the position of Director , Vaccine Drug Product Development. Vaccine Drug Product Development (VDPD) team is ... collaboration with various partners and stakeholders in development The Director will report to the Executive Director ...be responsible for a team of 10-20 senior and associate level scientists. The incumbent will be responsible for… more
- BluePearl (Langhorne, PA)
- …a collaborative, engaged, and passionate veterinary leader with several years of clinical experience to lead our team of emergency and specialty clinicians in ... the role of **Medical Director ** . The Medical Director will partner...(patient care, client and referral veterinarian satisfaction, and patient safety ), **supporting quality and operational initiatives, fostering a clinician-driven… more
- Merck (North Wales, PA)
- …and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS. **Primary activities ... include, but are not limited to:** + Reports to Executive Director or Associate Vice President, General Medicine + Develops worldwide product regulatory strategy… more
- Trinity Health (Langhorne, PA)
- …day-to-day operations of the Unified Enterprise Ministry's (UEM) Trinity Health Clinical Engineering (THCE) program at Regional Health Ministry (RHM) Hospital and ... develop and manage preliminary program budgets in collaboration with the Director THCE Regional Operations, finance and Regional Health Ministry Organizations… more
- Bristol Myers Squibb (Princeton, NJ)
- …and success of the BMS R&D pipeline . This role may report into Director , Clinical Data Management or Associate Director , Clinical Data Management . ... in their personal lives. Read more: careers.bms.com/working-with-us . **Functional Area Description:** Clinical Data Management k ey focus is to ensure data quality,… more
