- Eisai, Inc (Nutley, NJ)
- …members.Requirements Bachelor's or Master's degree with 15 or more years significant clinical pharmaceutical experience (ie, clinical development or ... and assess long-term resource, technology, and skill needs for respective program (s) within clinical quality area.Anticipate immediate and long-term risks… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …meetings on behalf of the Study Management Group Heads and/or Vice President, Clinical Development Operations.Contribute to and/or lead in the development ... centered around rare diseases and immune disorders. SummaryThe Senior Director of Clinical Operations will manage ...the priorities and needs of the assets within Early Development . They will provide operational insight to Program… more
- Merck & Co. (Cincinnati, OH)
- …the Regional RMSD Team Leader - within US Medical Affairs, Global Clinical Development , Research and Development (R&D).--Primary Activities:Identify, ... to identify potential investigators for consideration of participation in phase IIIV clinical development programs and provide scientific support for Research… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of emerging data (internal or competitive), such as congress updates and development program highlights.- Provides medical leadership in interactions with key ... research areas centered around rare diseases and immune disorders. SummaryThe Associate Director Global Medical Affairs Oncology (GMA), under the direction of the… more
- Merck & Co. (Rahway, NJ)
- …address asset value proposition, and clinical and value evidenceExperience in clinical development or outcomes research is desired Customer expertise, having ... Requirements: 25%Flexible Work Arrangements:HybridShift:Not IndicatedValid Driving License:NoHazardous Material(s):n/aRequired Skills:Business Development , Clinical Development , Commercial Strategies,… more
- Merck & Co. (Sacramento, CA)
- …study sites and identifies potential investigators to participate in phase II-IV clinical development programs, conducts Site Initiation Visits (SIVs), and ... Requirements: 50%Flexible Work Arrangements:RemoteShift:Not IndicatedValid Driving License:YesHazardous Material(s):n/aRequired Skills:Accountability, Clinical Development , Clinical Immunology, … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(QRBs).Collaborate with business process owners to monitor the effectiveness of clinical development processes through KQIs, demonstrating process control and ... and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director of...the involvement of regulated activities for medical affairs, or clinical development . requiredMust possess a solid understanding… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …communication of emerging data (internal or competitive), such as congress updates and development program highlights; and budget and forecast accuracy- In a ... as other research areas centered around rare diseases and immune disorders. SummaryThe Director US Medical Affairs (USMA) Oncology, under the direction of the Senior… more
- Merck & Co. (Rahway, NJ)
- …late-stage pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics ... is expected to be experienced in mammalian cell culture or purification process development , tech transfer of clinical or/and commercial processes, and pertinent… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …statistical issues related to proposed business plans.- Communicate with portfolio leaders in Clinical Development , Discovery, QCP, CDx, RA, MA or other relevant ... anchored in disease biology and drug mechanism of action, aligned with clinical development required- Deep knowledge in pathology-based and other biomarker… more
- Merck & Co. (Rahway, NJ)
- …and bringing subject matter expertise related to model informed drug discovery and development for programs .- The Director in Pharmacometrics should provide ... and Pharmacometrics (QP2) department drive model-informed drug discovery and development (MIDD) to routinely enable efficient drug discovery/ development … more
- Merck & Co. (North Wales, PA)
- …and business development activities independently, regardless of complexity, phase or program type, and is based on direct experience and the ability to ... "oversight" is expected at this level. In addition, the Director may be expected to take on one of...is business savvy and results oriented -Working knowledge of clinical drug development , with relevant experience that… more
- Merck & Co. (North Wales, PA)
- …Flexible Work Arrangements:RemoteShift:Valid Driving License:Hazardous Material(s):Required Skills:Adaptability, Clinical Development , Clinical Judgment, ... Job DescriptionThe Executive Director , Scientific Affairs (EDSA) maximizes meaningful bi-directional scientific...for patients. The EDSA leads a large investigator-initiated studies program in partnership with late-stage development teams… more
- Merck & Co. (Rahway, NJ)
- … development opportunities from evaluation through transaction close.The Executive Director oversees a team of four finance professionals who collaborate closely ... Development , Capital Management, Capital Markets, Cash Flow Management, Clinical Judgment, Communication, Debt Management, Detail-Oriented, Financial Analysis, Financial… more
- Eisai, Inc (Nutley, NJ)
- …management strategies in responsible therapeutic areas.Plan and implement Phase IV clinical development programs for assigned products.Create IIS strategies and ... strategic development , planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for products in the… more
- Merck & Co. (Rahway, NJ)
- …with Global Clinical Trial Operations (GCTO) and the broader Global Clinical Development (GCD)-Coordinates with Global Medical Scientific Affairs to ensure ... Job DescriptionThe Executive Director (ED) for US Medical Affairs (USMA) understands...sets the strategic direction for the Therapeutic Area (TA) program , and oversees the execution of the field medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …candidate will set goals and enumerate key scientific questions that will drive clinical development decision-making. In doing so, he or she will align ... counterparts in the Companion Diagnostics group to support the program . Other responsibilities will include but not be limited...statistical analysis plans, and aid in the construction of clinical development plans, clinical protocols,… more
- Eisai, Inc (Nutley, NJ)
- …lifecycle management strategies in responsible therapeutic areas.Plan and implement Phase IV clinical development and RWE programs for assigned products. Serve ... profile, we want to hear from you. The Medical Director will provide medical leadership for medical affairs strategy,...development , planning, implementation and oversight of Phase IV clinical trial programs and RWE studies within the Medical… more
- Insmed Incorporated (San Diego, CA)
- …senior leadership, as neededCollaborate with Clinical Development , Clinical Operations, CMC, QA/QC, Nonclinical, Program Management, and external ... regulatory review of documentation prepared by other technical functions supporting product development activities (eg, clinical protocols, clinical study… more
- Formation Bio (New York, NY)
- …and product teams. These predictive models will seamlessly integrate with our Clinical Development processes, directly impacting trial design and execution. This ... progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck...treatments to patients faster and more efficiently.About the PositionAs AD/ Director of Data Science - Platform at Formation Bio,… more
