- Merck & Co. (Rahway, NJ)
- …with company requirements and regulations are delivered and sustained. The Sr CCQM Lead supports large to medium size country/cluster clinical trial operations ... Quality Management (RCQM), and in collaboration with the Clinical Research Director(s), the Sr CCQM Lead ...performs QC activities (incl. QCVs) and conducts ad hoc site visits upon request.-On a regular basis and in… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... involving investigational compounds in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle of … more
- Merck & Co. (Rahway, NJ)
- …to achieve new milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical Development, and ... Clinical Supply across all modalities. We are interdependent across...build connections, and work across boundaries. Proven ability to lead the planning and execution of cross-functional strategic change… more
- Merck & Co. (Rahway, NJ)
- …operational planning, feasibility, and execution of a clinical trial.- May serve as the clinical trial team lead - May lead team in key study planning, ... This position leads the operational planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have the… more
- Merck & Co. (Rahway, NJ)
- …mission is to serve as PR&D's internal node for small molecule drug substance clinical manufacture, and as preferred site for first pilot of commercial small ... provides a high degree of technical and project management responsibility. The Senior Specialist - Process/Facility Engineering position will report to the Director,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDescription:The Senior Principal Scientist reports to the Senior Director Chemical Biotechnologies of Process Research & Development Enabling ... of others, and in driving the scientific strategy of the CBT group. The Senior Principal Scientist manages and prioritizes a portfolio of work that includes direct… more
- Merck & Co. (Rahway, NJ)
- …performing manufacturing, packaging, labeling, analytical testing, and distribution supporting the clinical supply chain on behalf of our company. Key activities ... affecting quality and efficiency. -Reviews draft policy and standards.Communicates with senior management within our company and the third-party organization as… more
- Merck & Co. (Rahway, NJ)
- …the role of- Senior Specialist.--QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to ... clinical pharmacology and pharmacometrics of oncology drugs from post-Preclinical...in one of the world's most research-intensive biopharmaceutical companies. Senior Specialists in QP2-I/O-will work in collaborative teams with… more
- Merck & Co. (Rahway, NJ)
- …Area and strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development.- The AVP provides strategic oversight for the early ... clinical space, determining and implementing the initial ...Cardiovascular & Respiratory strategy with other TA Heads (Discovery/Late-Stage) Lead key technical reviews for Cardiovascular & Respiratory assets… more
- Merck & Co. (Rahway, NJ)
- …Business Development opportunities. Leverage scientific acumen to partner with discovery and clinical colleagues in shaping research programs. Lead team analysis ... area capabilities. Partnering with key stakeholders, individual will benchmark competitor clinical data, business models and capabilities to develop insights and… more
- Merck & Co. (Rahway, NJ)
- …achieve this, we work closely with colleagues in Discovery, Pre- clinical , Early Development, Analytical, Formulation, and Commercial Manufacturing while providing ... Research & Manufacturing, in a fast-paced, multidisciplinary environmentParticipate in or lead 1) development of robust and scalable upstream processes for biologics… more
- Merck & Co. (Rahway, NJ)
- …to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of our company's Research & Development Division by:Developing ... relationships with health authorities.-Leads, develops, and coaches a team of senior -level employees to effectively manage programs and enable rapid and effective… more
- Merck & Co. (Rahway, NJ)
- …position available at our company's research facility. The Principal Scientist is a senior scientific role tasked with working closely with the group Director to ... define group strategy and to lead a team of scientists in solving complex analytical...of release, characterization, and stability assays for testing of clinical trial material and in support of product and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction ... in the US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Leaders (CSALs) at the Senior Director level for each respective programThis Clinical Science (CS) Group Lead will be responsible for overseeing multiple ... veterans and people with disabilitiesSummaryThis position will be the Clinical Science Group Lead in late phase...with a focus on patient safety and data integrity, site scientific engagement, and HA responsesInteractions with the internal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …needed- Clinical Development Expertise Strategy- In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of ... other research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an… more
- Insmed Incorporated (Bridgewater, NJ)
- …to the VP of Biometrics presents a unique opportunity to establish and lead a team of statisticians to collaborate closely with the Medical Affairs organization ... support in medical affairs activities, collaborating closely with Biometrics senior management and key business stakeholders.Provide leadership, guidance and… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Senior Medical Director of Gene Therapy will develop, implement, and lead ... geographic regions ensuring a cohesive approach. This role will develop and lead all medical affairs activities ensuring partnership within the team (medical… more
- Insmed Incorporated (Bridgewater, NJ)
- …teams, collaborating with subject matter experts in discovery, bioanalysis, pharmacokinetics, clinical development, CMC, and program management to drive the overall ... to contract research organizations. Provide strategic input to project teams and senior management regarding the potential impact of toxicology results on Program… more
- Insmed Incorporated (Bridgewater, NJ)
- …Scientific Communications. The Director of Field Medical Excellence will establish and lead worldwide Field Medical Excellence Forums. Position may be located in the ... Planning, Coaching Framework, Field Impact Assessment, MSL functional onboarding, Clinical Trial Support Framework, etcOperational Excellence - Develop consistent… more
