- Tris Pharma (Monmouth Junction, NJ)
- …and team success.We have an immediate opening in our Monmouth Junction, NJ facility for a Director , Drug Safety . The Director , Drug Safety ... vendors on expedited reports, as appropriate Participates in, and/or leads, key Drug Safety activities including, but not limited to: safety data review,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in R&D as early as possible. This led us to create the Translational Patient Safety Senior Director position, which will have unique exposure to Daiichi Sankyo's ... global drug portfolio from the Research stage to post marketing/lifecycle...within CSPV. He/she will spearhead developing a culture whereby safety is diligently considered prior to selecting promising candidates… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. Summary The Director , Clinical Safety , will be a product safety lead or part ... safety team, and be responsible for overall product safety strategy or specific areas of safety ...to strategically manage benefit-risk throughout the lifecycle of the drug . Specific responsibilities will vary depending on the stage… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilitiesSummaryThe Associate Director , Global Oncology Clinical Development (GOCD) Functional Excellence supports ... (AESI) educational materialsThis role works cross-functionally to collect / update safety and treatment information that is ultimately provided to educate patients… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. Summary Position leads very complex studies or entire drug project in study design, data analysis and interpretation of results independently ... with minimal supervision. This position provides input to entire drug development plans with minimal supervision and authors regulatory responses and other documents… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on ... Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at...writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND.Lead the CRO and vendor selection… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Team (SMT) materials- Supports overall program safety reporting (eg, Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), ... areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …oncology trials as well as submission-related activities, eg, integrated summary of safety (ISS) and integrated summary of efficacy (ISE)- Direct Project Support: ... guides, etc- Global Biostatistics Data Management (BDM) Strategy to Improve Drug Development: Leads implementation of vision and strategy, and identifies technology… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the end-to-end delivery of ... data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and External Vendors for the data services they… more
- Catalent (Philadelphia, PA)
- Position: Director QualityLocation: Philadelphia, PAPosition Summary: The Quality function is to build, monitor, and sustain a robust and effective quality system ... to, good manufacturing practice/quality system requirements of the Food and Drug Administration, state boards of pharmacy, European, South American, Japanese, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …oncology trials as well as submission-related activities, eg, integrated summary of safety (ISS) and integrated summary of efficacy (ISE).- Direct Project Support: ... guides, etc.- Global Biostatistics Data Management (BDM) Strategy to Improve Drug Development: Leads implementation of vision and strategy, and identifies technology… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …relevant stakeholdersPartners with cross-functional leaders incl. from across RD, Safety , Tech/Supply and Commercial to coordinate SMEs and engagement activities ... and a working knowledge of global regulations and guidelines regarding drug development (incl. CMC), regulatory submissions and corresponding regulatory agency… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …develop programming submission strategy, perform integrated analysis of efficacy and safety , generate submission data package, create TLFs to support submission QAs, ... and reporting of clinical trials preferred- Knowledge of all phases of drug development, including early and late phase clinical development and submission… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …& Annual Progress Reports, NDA Annual Reports & Annual ADE Reports, IND Safety Reports, Drug & Establishment Listings, responses to FDA communications, among ... other areas as needed. Relationships Reports to a Manager, Senior Manager, Associate Director or Director . Works with personnel in other departments including… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on ... is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This position may require… more
- J&J Family of Companies (Trenton, NJ)
- Director , Project Management- Drug Substance Manufacturing - 2406184665W **Description** Johnson & Johnson is recruiting for a Director , Project Management- ... which enable our business to best serve our customers and patients. The Director , Project Management Drug Substance Large Molecule is accountable for the… more
- J&J Family of Companies (Titusville, NJ)
- Director , Medical Safety Officer, Oncology - 2406185159W **Description** Johnson & Johnson, is recruiting for a Director , Medical Safety Officer, ... benefit/risk. The MSO will report to the GMS Sr. Director Product Safety Head, Oncology and oversee...methodology and design, medical monitoring of trials, assessment of drug risks and benefits, and safety assessment… more
- Bristol Myers Squibb (Princeton, NJ)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . The Director of Industrial Hygiene will be responsible for leading the development and ... industrial hygiene programs and policies across BMS through the Safety CoE. This role will work closely with global...guidance for the proper handling and use of potent drug compounds, basic laboratory reagents and materials, and physical… more
- Bristol Myers Squibb (Princeton, NJ)
- …and drug -interaction potential of drug candidates. Working closely with drug safety and clinical pharmacology, Dev DMPK plays a critical role in ... their personal lives. Read more: careers.bms.com/working-with-us . **Scientific Associate Director , DMPK Project Representative** Challenging. Meaningful. Life-changing. Those aren't… more
- Merck (West Point, PA)
- **Job Description** The Nonclinical Drug Safety department in West Point, PA is seeking a Toxicologist to conduct and/or monitor toxicity studies (GLP and ... non-GLP) as a Study Director or Study Monitor and to potentially serve as...from all contributing scientists into reports that characterize the safety profile of drug candidates. **Key Responsibilities**… more
