- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and updates Study Supply Plans in close communication with CSO project Management Lead .Responsible for the Clinical Label Development process which includes ... 7 or More Years of related experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical Development . preferredOncology experience… more
- 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)
- …management meetings on behalf of the Study Management Group Heads and/or Vice President, Clinical Development Operations.Contribute to and/or lead in the ... level, the incumbent may be expected to serve as Program level Delivery Lead on large and/or...data delivery and reporting.Accountable for the effective support of clinical activities within the Development organization.Ensure a… 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
- Formation Bio (New York, NY)
- …and collaborate with colleagues throughout the company, including our Medical/R&D, Biometrics, Clinical Program Management, and Clinical Operations teams to ... progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck...patients faster and more efficiently. About the PositionAs a Lead Product Manager, you will help execute on our… more
- Merck & Co. (Rahway, NJ)
- …is expected to be experienced in mammalian cell culture or purification process development , tech transfer of clinical or/and commercial processes, and pertinent ... talent development skills. Extensive experience as a drug substance lead for biologics pipeline programs. Strong capability in managing evolving timelines, … 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. (Boston, MA)
- …immunology programs, driving the Precision Medicine objectives in alignment with clinical development plans. Collaborating with Discovery, Translational Medicine ... Arrangements:HybridShift:Not IndicatedValid Driving License:NoHazardous Material(s):n/aRequired Skills:Bioinformatics, Bioinformatics, Biomarker Research, 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 ... expertise in the involvement of regulated activities for medical affairs, or clinical development . requiredMust possess a solid understanding of global health… 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
- Merck & Co. (North Wales, PA)
- …postgraduate training in a related subspecialtySignificant research experience as lead clinical investigator, specifically experience with investigator-initiated ... Travel Requirements: Flexible Work Arrangements:RemoteShift:Valid Driving License:Hazardous Material(s):Required Skills:Adaptability, Clinical Development , Clinical Judgment, … more
- Merck & Co. (Boston, MA)
- …the diagnostics strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development . The successful candidate will have an essential ... strategies and interact with various stakeholders to ensure alignment with clinical development timelines and regulatory requirements. Most importantly, the… 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 ... lead continuous improvement projects that require extensive product development experience and understanding of procedures and policies, and which significantly… 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 ... the direction of the Senior Director, USMA Oncology (US Medical Affairs team lead for compound), is responsible for assisting with defining compound/ program … more
- Insmed Incorporated (San Diego, CA)
- …senior leadership, as neededCollaborate with Clinical Development , Clinical Operations, CMC, QA/QC, Nonclinical, Program Management, and external ... regulatory results and ensure strategic integration of regulatory considerations into program plansIndependently lead the central messaging, preparation, and… 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 ... of the Senior Director/Director, GMA Oncology (Global Medical Affairs team lead for compound), is responsible for assisting with defining compound/ program… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pathology, to support design and implementation of translational pathology plans.- Lead development of the translational pathology strategic direction and ... statistical issues related to proposed business plans.- Communicate with portfolio leaders in Clinical Development , Discovery, QCP, CDx, RA, MA or other relevant… more
- Merck & Co. (North Wales, PA)
- …programming activities for multiple and/or large/complex late-stage drug/vaccine clinical development projects.Develop and execute statistical analysis ... and maintain statistical databases that support multiple stakeholder groups which include clinical development , outcomes research and safety evaluation.Act as a… more
- Merck & Co. (Rahway, NJ)
- …and Pharmacometrics (QP2) department drive model-informed drug discovery and development (MIDD) to routinely enable efficient drug discovery/ development ... offers an opportunity for the Pharmacometrics leader to drive pipeline impact and lead a talented group of pharmacometricians.This director will be part of a… 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...Data Science - Platform at Formation Bio, you will lead one of two critical arms of our Data… more
