- JENAVALVE TECHNOLOGY INC (Irvine, CA)
- …Range $120000.00 - $130000.00 Salary Description Job Title : Manager, Clinical Affairs (Case Review Board) Manager Title: Senior Director, Clinical ... Job Description Summary: Reporting to the Director of Clinical Affairs , the Manager, Clinical ...and Abilities Required for This Job: Working knowledge of clinical study execution and patient screen /… more
- JENAVALVE TECHNOLOGY INC (Irvine, CA)
- …Description Job Title: Senior Associate, Clinical Research Supervisor/Manager Title: Senior Manager, Clinical Affairs Job Description Summary: The ... play a key role in proactively supporting the conduct of pre-market clinical studies and ensure compliance with all regulatory requirements. The ideal candidate… more
- Merck & Co. (North Wales, PA)
- Job Description Role Summary: The Global Senior Director Medical Affairs (GDMA) is a subject matter expert in their area of responsibility (eg, defined tumor, ... (MD preferred) and recognized medical expertiseExperience in country/region medical affairs or clinical developmentStrong prioritization and decision-making… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Interventional, Non-Interventional, Managed Access Programs, and Investigator-Initiated Studies .Provide comprehensive quality oversight for Medical Affairs ... for the Sr. Director, representing the Quality organization at senior levels. The Director plays a pivotal role in...expertise in the involvement of regulated activities for medical affairs , or clinical development. requiredMust possess a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Director US Medical Affairs (USMA) Oncology, under the direction of the Senior Director, USMA Oncology (US Medical Affairs team lead for compound), is ... meetings. May serve as medical lead for select company-sponsored evidence generating studies /projects. Manages all medical aspects such as study document… more
- Eisai, Inc (Nutley, NJ)
- …capacity.Practical knowledge of FDA regulations/ICH guidelines regarding conduct of clinical studies in relevant therapeutic area.Substantial experience across ... for assigned therapeutic area. Under the direction of the Senior Medical Director, this role will be responsible for...strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs … more
- Insmed Incorporated (San Diego, CA)
- …prepared by other technical functions supporting product development activities (eg, clinical protocols, clinical study reports, statistical analysis ... teamsCommunicating regulatory strategies and risk assessments to cross-functional teams and senior leadership, as neededCollaborate with Clinical Development, … more
- Merck & Co. (Rahway, NJ)
- …Good Laboratory Practice (GLP) studies . The Senior Scientist is the primary clinical study team leader and has overall responsibility for a study . ... quality assurance etc.) and keeps them informed of the study progress.Works with Clinical Study ...Acceptance Test of electronic CRFs)May monitor clinical studies under the leadership of other senior … more
- Merck & Co. (Rahway, NJ)
- …of external opportunitiesThe Senior Director May: Supervise the execution of clinical studies . Work closely with a cross-functional group of experts in ... medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will...entire cycle of late-stage clinical development and studies , including development strategy, study design, initiation,… more
- Merck & Co. (Upper Gwynedd, PA)
- …The Senior Director will manage the entire cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, ... safety and efficacy as well as new drug applications, clinical study reports, or publication; and participating...of Clinical Scientists in the execution of clinical studies . --Work closely with a cross-functional… more
- Merck & Co. (North Wales, PA)
- …involving investigational compounds in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle of ... safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in...of Clinical Scientists in the execution of clinical studies . Work closely with a cross-functional… more
- Eisai, Inc (Philadelphia, PA)
- …key scientific, clinical and research insights from KOLs to Medical Affairs .Develop, implement and present to management plans to support Medical Affairs ... Maintain and demonstrate thorough and up-to-date knowledge of disease state, study methodology, clinical information, and product data.Demonstrate full knowledge… more
- Merck & Co. (Boston, MA)
- …of Phase I studies ; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, ... earliest stages of target identification and validation, and executing clinical studies to evaluate the relevance of...drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations)Provide … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …GMA clinical operations teams as part of evidence generation forums and study teams for Local/Regional Medical Affairs company sponsored study concepts ... other research areas centered around rare diseases and immune disorders. SummaryMedical Affairs leader for the portfolio of early asset compounds under the… 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 ... research areas centered around rare diseases and immune disorders. SummaryUS Medical Affairs leader for assigned compound under the supervision and leadership of the… more
- Insmed Incorporated (NJ)
- …with stakeholders across the company including market access, marketing, medical affairs , and clinical development to understand and support Insmed's ... burden of illness studies , patient reported outcomes studies and clinical trial endpoint selection, disease...members within the company, including market access, marketing, medical affairs , and clinical development to support Insmed's… more
- Genmab (NJ)
- …territory plans in alignment with regional, national, and global Medical Affairs strategiesProvide insights/feedback on emerging scientific/ clinical data that ... RoleGenmab is currently seeking a Hematology Medical Science Liaison (MSL)/ Senior MSL (Sr. MSL) to be a part of...opportunity of a passionate, high profile, high-impact Global Medical Affairs team, and work in a dynamic and collaborative… more
- Eisai, Inc (California, OH)
- …is your profile, we want to hear from you. Summary: The MSL ( Senior Medical Science Liaison or Principal Medical Science Liaison) is a field-facing representative ... of US Medical Affairs with a primary responsibility of engaging in the...'big picture' as it relates to the business. The Senior / Principal MSL brings relevant insights from the field… more
- Kenai Therapeutics (San Diego, CA)
- …Oversee the creation and execution of critical clinical documents, including study protocols, clinical study reports, investigator brochures, and safety ... the Chief Medical Officer (CMO), the Vice President of Clinical Operations is a senior leadership position...with travel requirements. The role will require travel to clinical study sites and external vendors as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Global Medical Affairs Oncology (GMA), under the direction of the Senior Director/Director, GMA Oncology (Global Medical Affairs team lead for compound), ... indications.- Support as medical lead for select company-sponsored GMA evidence generating studies /projects. Manages all medical aspects such as study document… more
