- Daiichi Sankyo, Inc. (Bernards, NJ)
- …valid clinical interpretation of study results as Clinical Study Leader, medical monitor or regional clinical /Translational Medicine and ... matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead. ResponsibilitiesStudy Strategy: Clinical study leader (CSL)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …valid clinical interpretation of study results as Clinical Study Leader, medical monitor or regional clinical /Translational Medicine and ... Development in Project Teams, possibly as Global Clinical Lead. Responsibilities: Study Strategy: Clinical study leader (CSL) or major scientific/medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Phase 1 (specifically Clinical Pharmacology) studies , support Phase 2/3 studies , represent function on study and project teams, and participate in and ... as Study Team Leader for Phase 1 Clinical Pharmacology studies , and provides clinical...KOL and regulatory interactions at project level, interacts with regional and global study and project team… more
- Merck & Co. (North Wales, PA)
- Job Description Role Summary: The US Regional Director Medical Affairs (RDMA) is responsible for driving execution of scientific & medical affairs plans for ... They are impactful members of regional cross-functional teams, including regional Commercial, Outcomes Research, Clinical Operations, Policy and Market… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Modeling and Simulation plans, design and lead study teams to execute Clinical Pharmacology studies , conduct hands on population PK and PKPD analyses and ... specialist in PK-PD and Pop PK-PD concepts, phase 1-4 clinical studies , literature, and regulatory guidelines and...KOL and regulatory interactions at project level, interacts with regional and global study and project team… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …relevant working experience in externally sponsored research, including IIS and collaborative studies required4 or More Years in a clinical management setting ... areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of Global Medical Affairs'… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …strategic documents, including NNI Evidence Generation Plans and Product Development Plans Clinical study management: Provide regional medical & scientific ... Position Use medical and clinical expertise in design, implementation and monitoring of clinical studies (from Phase 1 to 4) in a team setting. Provide… more
- Merck & Co. (Upper Gwynedd, PA)
- …company-sponsored studies and areas of interest for the investigator-initiated study program. The GDMA will interact with other TA groups (both at ... Job DescriptionThe Global Director Medical Affairs (GDMA) Oncology Assets & Pipeline...the global and regional level), as well with other relevant internal stakeholders… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with GMA Clinical Operations and other cross-functional and regional stakeholders.Provides support in review of investigator-initiated studies (IIS) ... indications.Serve as medical lead for select company-sponsored GMA evidence generating studies /projects. Manages all medical aspects such as study document… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …studies , including Ph 3b/4, EAP, externally sponsored research, external clinical collaborations, and observational studies required- Prior experience working ... areas centered around rare diseases and immune disorders.SummaryThe Senior Director , Global Oncology Medical Affairs, Evidence Generation role is responsible… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …studies , including Ph 3b/4, EAP, externally sponsored research, external clinical collaborations, and observational studies requiredTravelAbility to travel up ... research areas centered around rare diseases and immune disorders. SummaryThe Director , Global Oncology Medical Affairs, Evidence Generation role is responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary Director , Global Medical Affairs Oncology Publications works with Cross Functional Team ... GMA Oncology activities as needed. ResponsibilitiesCollaborate with Global and Regional Medical Affairs, co-development company and various cross functional teams… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical leadership: Leads USOMA teams as part of evidence generation forums and study teams for Local/ Regional Medical Affairs company sponsored study ... for assigned compound under the supervision and leadership of the Executive Director of Medical Research and Strategy, US Oncology Medical Affairs (USOMA). Develops… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Development, Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and Clinical Study Report (CSR): Provides oversight of activities ... performed by direct reports and biostatisticians across the regional /global function, when assigned. Develops, directs, prioritizes and monitors all assigned… more
- Merck & Co. (Upper Gwynedd, PA)
- …Outcome Research (OR) data generation and coordinates local data generation studies (LDG) with ORSupports the Investigator-Initiated Study programLeads talent ... Job DescriptionThe Executive Director , Global Medical and Scientific Affairs (EDMA) GYN...They lead a team of TA dedicated global and regional directors and associate directors. The EDMA engages with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …internal and external panels related to Health Authority initiatives.Review of clinical study protocols, health authority dossiers and briefing books.Education ... Sankyo governance processes, and on Joint Alliances.Assess and articulate regional interdependencies, program regulatory risks, and opportunities in the development… more
- Novo Nordisk Inc. (Detroit, MI)
- … regional FMA team members to ensure integrated comprehensive coverage of regional clinical and scientific needs Coordinates with key internal stakeholders to ... to ensure timely review, initiation, and completion, as well as publication of study results. Provides clinical support in cooperation with other Novo Nordisk… more
- Daiichi Sankyo, Inc. (Raleigh, NC)
- …informationIdentifying and appropriately facilitating engagement of qualified 1) investigators and study committee members for DSI clinical research programs, 2) ... clinical research and medical education preferred Principal MSL/Associate Director MSLExperience Qualifications:5 or More Years' experience including medical &… more
- Sunrise System Inc (Gaithersburg, MD)
- …the GPD provides strategic operational leadership and oversight of a suite of global clinical studies within a program covering all clinical program ... Job Title: Global Clinical Operations Program Director Job ID:...of clinical operations, Experience with development and implementation of digital health initiatives in Clinical Studies… more
- Maury Regional Health (Columbia, TN)
- …etc. under the general supervision of a Polysomnographic Technologist (RPSGT) and/or the clinical director (MD, PhD, DO) or designee. Credentials / Education: . ... pay, comprehensive benefits package and complementary parking on campus At Maury Regional Health, we prioritize clinical excellence and compassionate care in… more
