- Merck & Co. (Rahway, NJ)
- …effectively communicate with stakeholders at various levels, including cross-functional teams, senior management, external vendors, and clinical sites. Strong ... Job DescriptionThe Global Clinical Supply (GCS) organization is accountable for managing...emonstrates high capability to solve unstructured problems, make informed risk decisions considering both technical & business risks, &… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM ( Risk Based Quality Monitoring) sets ... Collaboration and partnership with other functions and stakeholders in supporting clinical trial monitoring and execution through RBQM activities. Accountable for… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... opportunity is fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development of robust compositions,… more
- Merck & Co. (Rahway, NJ)
- …Development Associate Principal Scientist - Development Strategy, Design Controls(Associate Director Equivalent) Our company's Device Development & Technology (DD&T) ... development and design control principles to positively support and influence clinical and commercial combination product development and launches to ensure they… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …A cross-Oncology Development Medical Doctor position reporting to the Head Clinical Development Functional Excellence. This position complements CSPV and GMA efforts ... of the Head of Functional Excellence, across key functions to improve the benefit- risk in patients treated within the oncology compounds throughout the course of … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and propel data-driven decision-making.Promotes a culture of creativity and risk -taking, alongside developing processes that encourage experimentation and innovative ... Operations, including but not limited to - Commercial, Patient Services, CMR ( Clinical , Medical, Regulatory), Finance, and Novo Nordisk global colleagues, to deliver… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …execute daily production schedules.Will have 3-6 direct reports ranging from Associate Director , Senior Manager, and Manager.Oversee the hiring, development, and ... in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations...production of a personalized cell therapy to support both clinical and commercial requirements in either a Grade C… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements ... documents where necessary with supervision. This position conducts regulatory risk assessment and recommends developmental options with supervision, and this… more
- Formation Bio (New York, NY)
- …than the industry can progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately limit the number of ... processes, and capabilities to accelerate all aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma… more
- Merck & Co. (Rahway, NJ)
- …pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research ... high yields along with superior product quality and allow speedy progression for clinical studies and commercial launch. The candidate will be a member of the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in? Are you ready to experiment with us? The Position The Director , Market Intelligence and Portfolio Insights will leverage Competitive Intelligence methodologies ... to provide key insights into the biopharmaceutical landscape across clinical , commercial, and enterprise domains. This role involves applying data interpretation and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a Senior Engineer in Device Design and Process Development group, you will be part of our Research & Development team that designs and develops ... benchtop/low-volume to high-volume clinical and commercial assembly equipment and processes for medical...processes for medical devices/drug delivery systems. Reporting to the Director responsible for this area, you will partake in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to external diagnostic business partners specifically:Use of CTA/CDx within clinical trialsDevice protocols and SAPsDevice non-significant/significant risk ... of a CDx study/IVDR performance evaluation study integration of an assay into clinical testing (before testing) and once data is ready for CDx submission (after… more
- Catholic Guardian Services (Bronx, NY)
- …Category Family Foster Care Description Catholic Guardian Services Job Description Title: Senior Director of Social Services, Family Foster Care Programs Reports ... of care to another, including oversight of a high risk case review protocol, and a smooth transitioning process...members. When instructed by the agency's executive team the Senior Director of Social Services is expected… more
- Invivyd (New Haven, CT)
- …Be part of making a difference. Be part of Invivyd. Job Title: Senior Manager/Associate Director , Drug Safety and Pharmacovigilance Operations Position summary: ... risk management and pharmacovigilance for all of Invivyd's Clinical Trials and post marketing. Responsibilities: Responsible for performing day-to-day safety… more
- Jamie Grayem (Downey, CA)
- Director , Patient Safety & Clinical Risk Management Downey, CA, US$170,400 - $205,100 + Performance Bonus + Relocation Assistance + Sign On Bonus + Paid ... below, this position is also responsible for overseeing critical risk management projects such as cybersecurity, changes to the...Data CenterWill work with other peers in quality, IP Director , Clinical Quality Director for… more
- Clinical Dynamix, Inc. (Waltham, MA)
- …need for a Contractor to be in place asap)! Reporting to the Sr. Director , Clinical Excellence Operations the Senior Manager/Associate Director , ... advanced degree preferred. *A minimum 5-6+ years (Sr. Manager)/8+ years (Associate Director ) of relevant experience in Clinical Operations roles within the… more
- Olema Oncology (San Francisco, CA)
- …better, longer. For more information, visit us at www.olema.com. About the Role Director , Regulatory Labeling As the Director , Regulatory Labeling, reporting to ... Affairs and Quality Assurance you will lead the development of labeling for clinical supplies as well as development of commercial labeling materials for Olema… more
- Bristol-Myers Squibb Company (New Brunswick, NJ)
- …teams and leaders across the BMS network. This position will report into the Senior Director , Risk Management. Key Responsibilities: Provide strategic and ... and executed in these processes. In partnership with the Senior Director , Risk Management, champion...perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation,… more
- Janux Therapeutics (San Diego, CA)
- Janux Therapeutics seeks a Director of Clinical Operations to lead early-phase autoimmune clinical trials from its newly announced A daptive Immune R esponse ... and Ex-U.S. regions) and will be responsible for all aspects of assigned clinical trials. This role also assures adherence to GCP, regulations and applicable… more
