- Daiichi Sankyo, Inc. (Bernards, NJ)
- …when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution ... around rare diseases and immune disorders. Job Summary: The Senior Director sits within Global Oncology Clinical ...and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring) sets the vision ... Collaboration and partnership with other functions and stakeholders in supporting clinical trial monitoring and execution through RBQM activities. Accountable for… 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 ... treated within the oncology compounds throughout the course of clinical development through the commercial setting. In this role,...KEE's for advice on complex patient safety issues. Communications lead with HCP's (PI's, sub- PI's, nurses) at the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary: Senior clinical operational leader accountable for operational planning and ... managing multiple direct reports. Responsibilities:Operational Strategy:Align with the Head of Clinical Development Operations or Senior Director, Clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 ... as well as UK and Switzerland. CDx RA Strategy : Align strategy with lead CDx RA representative(s) and represent Global CDx Regulatory position and provide input and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …respond appropriately to these concerns, barriers, and the evolving marketplace. The role will lead the training efforts and support the needs of a variety of DSI ... Teams, Field Reimbursement Managers, Field Sales Forces, Marketing, Oncology Clinical Nurse Educators, Oncology Market Alliances and other appropriate stakeholders.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas for translational medical safety and make a meaningful impact on clinical development at the program level. Lead projects to enhance processes ... and prioritizing CoE resources for key programs. The role will also provide senior safety leadership and guidance on complex issues across the DS portfolio,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director, Head Medical affairs Quality Assurance in Global RD/PV QA is ... and Specialty Medicine portfolios, in alignment with the business strategy Lead the DSG inspection management activities by ensuring continued submission, compliance… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Managed Markets, Legal, Compliance, and Finance. The position has high exposure to senior management and requires a highly motivated individual who is able to work ... that have high ROI Agency/Vendor management experience required Ability to lead and collaborate on cross-functional teams required Anticipates problems and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Product Evolution o Establish product strategy and regulatory activities related to new clinical data or label changes. Lead modification to marketing strategies ... as we embark on shaping our future. The Position The Hemophilia TA Lead is instrumental in shaping and executing NNI's strategic direction and initiatives within… more
- Merck & Co. (Rahway, NJ)
- …to customers both internal and external to GCS and serves as the lead GCS spokesperson at clinical and development related meetings.- Working independently, ... are not limited to:--Interacts closely with key partner organizations (as a lead GCS Planning program representative) such as clinical development, regulatory,… more
- Merck & Co. (Rahway, NJ)
- …offers an opportunity for the Pharmacometrics leader to drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to ... efforts to strengthen our pharmacometrics capabilities on a continuous basis. The Senior Director will be accountable for directing a team of pharmacometricians with… more
- Merck & Co. (Rahway, NJ)
- …to join Biologics Process Research & Development (BPR&D) as a Senior Principal Scientist.BPR&D within Research Laboratories is committed to rapidly delivering ... achieve our goals, we work closely with colleagues in Discovery, Pre- clinical , Early Development, Analytical, Formulation, and Commercial Manufacturing, all within a… more
- Merck & Co. (Rahway, NJ)
- …business development assessments of external opportunities.Managing other Directors and/or Senior Directors responsible for Atherosclerosis clinical development ... Scientist) has primary responsibility for the planning and directing of clinical research activities involving new or marketed medicines in the Atherosclerosis… more
- Merck & Co. (Rahway, NJ)
- …units and senior leaders with the ability to influence and lead change while building strong alignment and partnerships.Proven ability to develop and implement ... Job DescriptionUS Lead , Medical Modernization - V&IReporting to the Head of Strategy Realization, Medical Modernization, the US Leader for Medical Modernization (MM)… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a consistent brand/therapy area vision and message. Relationships Reports to Brand Lead or Consumer Strategy Lead . Collaborates with cross-functional and global ... to ensure brand/therapy area success. Co-develops and presents compelling plans for Brand Lead endorsement. Serves as an advocate for the US marketing initiatives in… more
- Merck & Co. (Rahway, NJ)
- …in the Formulation, Laboratory, and Experimentation (FLEx) Sterile GMP Clinical Manufacturing facility.Contribute to equipment and facility design, system ... quality representatives, and other team members to ensure the quality of the clinical supplies, the scientific rigor of the processes, and ultimately to enable the… 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
- Eisai, Inc (Nutley, NJ)
- …a team of Clinical Operations staff to oversee all aspects of clinical trial development. Lead clinical study inspections from preparation through ... we want to hear from you.The Vice President/Head of Global Clinical Operations is a senior leadership role responsible for overseeing all aspects of clinical… more
