Emergency Medicine Assistant Medical Director in Edison, NJ TeamHealthEmergency Medicine Assistant Medical Director in Edison, NJEdison, NJFull timeThis leadership opportunity is ideal for a board-certified or board-eligible emergency physician who is passionate about clinical excellence, physician engagement, operational performance, and advancing quality patient care in a high-acuity community hospital setting. As assistant medical director, you will partner closely with the medical director and hospital leadership to support the clinical, operational, and strategic success of the emergency department while maintaining an active clinical practice.
Medical Director in Freehold, NJ TeamHealthMedical Director in Freehold, NJFreehold, NJPart timeOur comprehensive clinical and operational leadership team will support your transition into our medical practice with a comprehensive 3-month onboarding program along with a dedicated clinical field mentor and support from industry leading clinical experts in post-acute medicine. The medical practice is part of TeamACO, a dedicated long-term Accountable Care Organization participating in the Medicare Shared Savings Program for our clinicians, which could result in you receiving a portion of the shared savings if certain criteria are met.
Pediatric Emergency Medicine Medical Director in Summit, NJ TeamHealthPediatric Emergency Medicine Medical Director in Summit, NJSummit, NJ$190–$220 / hourFull timeTeamHealth is seeking a visionary, board-certified pediatric emergency medicine (PEM) physician to serve as medical director at the Overlook Medical Center Pediatric Emergency Department in Summit, New Jersey . With a dedicated pediatric connection to Goryeb Children's Hospital in Morristown, Overlook offers robust support and seamless care to more than 100 pediatric specialists.
NewEmergency Medicine Medical Director Inhospital Physicians CorpEmergency Medicine Medical DirectorBayonne, NJPhysical Demands: This physician role requires stamina in fast-paced healthcare: prolonged standing/walking (8-12 hrs/shift); rapid emergency movement (sprints, crowds); lifting/carrying 25-50 lbs equipment; pushing/pulling 100 lbs (beds/carts) with aid; frequent bending/stooping/kneeling for care; constant reaching/fine motor skills (suturing/IVs); occasional climbing/balancing; tolerating stressors (temps, noise, fluids, hazards) during irregular shifts/on-call/infection risksaccommodations for disabilities; varies by setting (clinic/ER). If youre an Emergency Medicine leader ready to take the next step in your career, apply today and join a team committed to delivering outstanding emergency care.
Emergency Medicine Assistant Medical Director in Summit, NJ TeamHealthEmergency Medicine Assistant Medical Director in Summit, NJSummit, NJFull timeOverlook Medical Center offers a wide range of services, including the Atlantic Neuroscience Institute, The Gagnon Cardiovascular Institute, and award-winning emergency medicine services. A hospital with a proven track record of clinical excellence, Overlook Medical Center has been ranked by Healthgrades in the top five percent of hospitals in the nation for the treatment of stroke six years in a row.
NewExecutive Medical Director, Clinical Development - M.D. (Nephrology) Clinical Dynamix, Inc.Executive Medical Director, Clinical Development - M.D. (Nephrology)Jersey City, NJThe Clinical Development Executive Medical Director is the clinical leader of the specific clinical programs assigned with responsibility for outlining the overall clinical development strategy in line with regulatory requirements and sound scientific rationale, designing the clinical protocols, guiding the Clinical Operations team towards the adequate implementation of such protocols, ensuring adequate medical monitoring activities are implemented for the conduction of clinical studies and analyzing the data from the clinical program. The individual will also be responsible for ensuring adequate implementation of the global safety surveillance and pharmacovigilance for the investigational products, including review and analysis of safety data from clinical trials and other permitted sources (e.g., early access/expanded access programs, if applicable), identification and investigation of safety signals, and management of the benefit-risk profile for assigned compounds.
Pediatric Emergency Medicine Medical Director in Edison, NJ TeamHealthPediatric Emergency Medicine Medical Director in Edison, NJEdison, NJ$190–$220 / hourFull timeThis leadership role offers the opportunity to guide clinical excellence, mentor physicians, and collaborate with hospital leadership to deliver outstanding pediatric emergency care. Join our dynamic group of physician colleagues at a premiere practice location that serves 20,000 pediatric patients annually!
Director, Global Oncology Medical Affairs, Scientific Partnerships Daiichi Sankyo, Inc.Director, Global Oncology Medical Affairs, Scientific PartnershipsBasking Ridge, NJ$201,840–$302,760 / yearFull timeLead the strategic identification, prioritization, and management of Cooperative Groups, academic networks, and external scientific partnerships; act as the primary medical interface to advance high-priority collaborations. The role will also establish and operationalize the infrastructure, processes, and collaboration frameworks required to support joint research and educational initiatives with Cooperative Groups, Academic Research Organizations and other research networks.
Director, Global Oncology Medical Affairs Patient Advocacy Daiichi Sankyo, Inc.Director, Global Oncology Medical Affairs Patient AdvocacyBasking Ridge, NJ$201,840–$302,760 / yearFull timeServe as a key strategic partner to Clinical Development, Medical Affairs, and cross-functional teams to incorporate patient insights and patient experience data into clinical development plans, protocol design, evidence generation, and broader organizational decision-making. Excellent interpersonal, oral and written communication skills including strong presentation skills; competent and confident in presenting to senior leadership as well as in lay terms to appropriately engage with patients and advocates required.
NewChief Medical Officer Clinical Dynamix, Inc.Chief Medical OfficerJersey City, NJKey requirements will include: ·An MD or MD/PhD with strong leadership skills and proven biopharmaceutical industry experience in leading clinical development of therapeutic programs, specifically in the Nephrology space is essential. A record of accomplishment including developing, planning, designing and implementing clinical studies in the Nephrology space and experience with the successful registration of therapeutics is highly desirable.
Director of Referral Relations Mitchell MartinDirector of Referral RelationsHamilton, NJ$160,000–$180,000 / yearBy applying for this job, you agree to receive AI-generated calls, text messages, and/or emails from Mitchell Martin Inc and its affiliates and contracted partners at various frequency through traditional and automated methods. • The position involves leading referral growth efforts in healthcare, focusing on strengthening relationships among various medical professionals.
Assistant Director of Nursing - RN Care-OneAssistant Director of Nursing - RNHamilton Township, NJ$91,000–$95,000 / yearAlong with the Director of Nursing, promote positive employee relations, strong customer service ethic and commitment to ongoing staff education and training, May exercise direction over the department in the absence of the Director of Nursing. Assist the Director of Nursing with regulatory compliance and ensure effective communication strategies with all levels of nursing staff to promote effective care delivery.
NewTax Director Kforce Inc.Tax DirectorParsippany, NJ$175,000–$275,000Employee pay is based on factors like relevant education, qualifications, certifications, experience, skills, seniority, location, performance, union contract and business needs. By clicking “Apply Today” you agree to receive calls, AI-generated calls, text messages or emails from Kforce and its affiliates, and service providers.
NewSite Director at Wrightstown Elementary KinderCare EducationSite Director at Wrightstown ElementaryNewtown, PAWhen you join our team as a Site Director, you will: Lead and supervise a group of teachers to create unique and engaging classroom experiences, leverage and develop “best in class” educators to be passionate and committed professionals. At KinderCare Learning Companies, the first and only early childhood education provider recognized with the Gallup Exceptional Workplace Award , we offer a variety of early education and child care options for families.
NewSite Director at Gilmore J. Fisher Middle School KinderCare EducationSite Director at Gilmore J. Fisher Middle SchoolEwing Township, NJ$16.35–$33.15When you join our team as a Site Director, you will: Lead and supervise a group of teachers to create unique and engaging classroom experiences, leverage and develop “best in class” educators to be passionate and committed professionals. At KinderCare Learning Companies, the first and only early childhood education provider recognized with the Gallup Exceptional Workplace Award , we offer a variety of early education and child care options for families.
NewSite Director at Middletown Village Elementary School KinderCare EducationSite Director at Middletown Village Elementary SchoolMiddletown Township, NJ$21.55–$30.20When you join our team as a Site Director, you will: Lead and supervise a group of teachers to create unique and engaging classroom experiences, leverage and develop “best in class” educators to be passionate and committed professionals. At KinderCare Learning Companies, the first and only early childhood education provider recognized with the Gallup Exceptional Workplace Award , we offer a variety of early education and child care options for families.
NewRegistered Nurse (RN) - Director of Nursing - $95K-145K per year GentivaRegistered Nurse (RN) - Director of Nursing - $95K-145K per yearEast Hanover, NJ$125,000–$135,000 / yearOur nationwide reach is powered by a family of trusted brands that include: Hospice care: Gentiva Hospice, Emerald Coast Hospice Care, Heartland Hospice, Hospice Plus, New Century Hospice, Regency SouthernCare, SouthernCare Hospice Services, SouthernCare New Beacon. With more than 550 locations and thousands of compassionate clinicians across 38 states, our place is by the side of those who need us – from helping people recover from illness, injury, or surgery in the comfort of their homes to guiding patients and their families through the physical, emotional, and spiritual effects of a serious illness or terminal diagnosis.
Resident Care Director, RN Brightview Senior Living, LLCResident Care Director, RNParamus, NJ$120,000–$130,000After the community opens, you will get to provide ongoing nursing assessments and care oversight, identify clinical trends, implement corrective action and monitor the accurate delivery of medications to our residents, in addition to working with the residents’ physicians and medical personnel on the best plan of action for their continued care. About Us: Overview: The Health Services Director, Registered Nurse at Brightview Senior Living exemplifies the vision, the mission, and the vibrancy of the organization and leads the delivery of exceptional clinical care to our residents.
NewBusiness Development Director Weichert, RealtorsBusiness Development DirectorParsippany, NJ$90,000–$110,000 / yearExecutes a diverse range of prospecting activities including cold calling, needs assessments, direct mail campaigns, sales presentations, technology demonstrations, promotional items, networking events, trade shows and conferences, and client forums. The rate of pay offered is dependent upon several factors, including but not limited to, the candidate’s relevant skills, education, work experience, job location/geographic region, and/or certifications.
OB Hospitalist - Director Opportunity - Belleville OptigyOB Hospitalist - Director Opportunity - BellevilleBelleville, NJHighly relational, able to build strong rapport and positive working relationships with all stakeholders (Hospital leadership, hospitalist teams, nurses, staff physicians, and OBHG corporate staff). Will collaborate with the MMD, MDO or VPCO to ensure the clinical team is delivering a quality program that achieves both OBHG's and the hospital's clinical and operational objectives.
OB Hospitalist - Director Opportunity - Plainsboro OptigyOB Hospitalist - Director Opportunity - PlainsboroPlainsboro, NJHighly relational, able to build strong rapport and positive working relationships with all stakeholders (Hospital leadership, hospitalist teams, nurses, staff physicians, and OBHG corporate staff). Will collaborate with the MMD, MDO or VPCO to ensure the clinical team is delivering a quality program that achieves both OBHG's and the hospital's clinical and operational objectives.
OB Hospitalist - Director Opportunity - Freehold OptigyOB Hospitalist - Director Opportunity - FreeholdFreehold, NJHighly relational, able to build strong rapport and positive working relationships with all stakeholders (Hospital leadership, hospitalist teams, nurses, staff physicians, and OBHG corporate staff). Will collaborate with the MMD, MDO or VPCO to ensure the clinical team is delivering a quality program that achieves both OBHG's and the hospital's clinical and operational objectives.
Senior Director, Clinical Development - Hematology Daiichi Sankyo, Inc.Senior Director, Clinical Development - HematologyBasking Ridge, NJ$280,350–$467,250 / yearFull timeMay contribute to addressing questions about medical decisions, clinical data review, protocol deviations, etc., and/or scientific aspects of the study during FDA, MHRA, EMA, and PMDA interactions, such as pre-submissions, end of phase 1/2, and inspections. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders.
Senior Director, Clinical Development Daiichi Sankyo, Inc.Senior Director, Clinical DevelopmentBasking Ridge, NJ$280,350–$467,250 / yearFull timeMay contribute to addressing questions about medical decisions, clinical data review, protocol deviations, etc., and/or scientific aspects of the study during FDA, MHRA, EMA, and PMDA interactions, such as pre-submissions, end of phase 1/2, and inspections. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders.
Senior Director, Clinical Safety MD Daiichi Sankyo, Inc.Senior Director, Clinical Safety MDBasking Ridge, NJ$280,350–$467,250 / yearFull timeThe individual assuming this role may function as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other departments to strategically manage benefit-risk throughout the lifecycle of the drug. Depending on the status of development of the compound, lead and medical-scientifically direct a team of physicians and scientists responsible for a compound/product including project-specific training and coaching of team members and review of team output cross-functionally.
Director, Clinical Safety Scientist Daiichi Sankyo, Inc.Director, Clinical Safety ScientistBasking Ridge, NJ$201,840–$302,760 / yearFull timeRisk Management (Signal identification, evaluation, mitigation): Is a key participant in developing and implementing the risk management strategy for assigned products/ TAs; Independently integrates and analyzes safety data from multiple sources to deliver comprehensive conclusions; Independently identifies gaps in safety surveillance plans/RMPs and escalates appropriately. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders.
Senior Director, Clinical Safety Scientist Daiichi Sankyo, Inc.Senior Director, Clinical Safety ScientistBasking Ridge, NJ$242,700–$404,500 / yearFull timeLead scientist team to collaborate with safety physicians, regulatory affairs, clinical development, other functions and external partners to deliver high-quality safety assessments, regulatory submissions, aggregate reports, and responses to health authority queries. In addition to operational oversight, this role contributes to the development of global safety processes, talent capability building, and strategic alignment across the broader Clinical Safety and Pharmacovigilance (CSPV) function and the enterprise.
Director, PV QA DSI Daiichi Sankyo, Inc.Director, PV QA DSIBasking Ridge, NJ$184,240–$276,360 / yearFull timeThe role will participate in other PV QA projects, tasks, and initiatives as needed and as instructed, including but not limited to including planning and PV QA executing the Pharmacovigilance Quality Strategy Plan in alignment with the DSI business objectives, review of key REMS documents, Health Authority Commitments, Quality Event management, escalation process and the CAPA oversight across applicable functional areas. Lead the PV inspection management activities by ensuring readiness, compliance, and inspection preparedness for the respective regulatory inspections in alignment with regulatory and company strategy, including coordinating and supporting preparation of CSPV teams and active participation and management of these processes, specifically in the US.
Associate Director, Data Quality & Integrity, Global R&D & PV QA Daiichi Sankyo, Inc.Associate Director, Data Quality & Integrity, Global R&D & PV QABasking Ridge, NJ$153,600–$230,400 / yearFull timeLeadership & Strategy Execution – Lead execution of key elements of the global Data Integrity strategy and ensure alignment across R&D, PV, and MA.Translate strategic objectives into multi‑year roadmaps and annual operating plans for data integrity and computerized systems oversight (business operational data focus).Serve as a senior subject matter expert for data integrity and GxP computerized systems governance, advising leadership on risk‑based prioritization and compliance posture. This role leads cross‑functional initiatives, establishes program‑level oversight frameworks, mentors and develops QA capability, and partners with senior stakeholders to ensure robust data governance, regulatory compliance, and measurable continuous improvement.
NewDirector of Health & Wellness (RN/DON) Mattison CrossingDirector of Health & Wellness (RN/DON)Freehold, NJDiscovery Management Group leads one of the nation’s most purpose-driven and people-centered senior living organizations, managing and enhancing senior living communities across the United States. For residents who need structured routines and a higher level of attention, our SHINE® Memory Care community provides a secure, engaging environment supported by a trained team.
Associate Director, External Supplier QA GMP Daiichi Sankyo, Inc.Associate Director, External Supplier QA GMPBasking Ridge, NJ$153,600–$230,400 / yearFull timeCross-Functional Team Participation: Responsible for working with Quality Leaders in each operating site to influence and affect the necessary operations managed through the leadership teams and will partner closely with other Subject Matters Expert across all the Functional Units (Global ADC Team Members, Pharmaceutical Technology, QA-GMP and QA R&D functional areas, Regulatory Affairs – CMC, Pharmacovigilance, Medical Affairs and Supply Chain) to ensure compliant operations. Quality Management System (QMS): Ensures and support that a robust QMS is in place at CMOs with respect to the facility, equipment & lab instruments, engineering, maintenance, computerized systems and validation activities which complies with GMP guidelines such as ICH and PIC/s as well as FDA regulation requirements, industry best practices and will withstand regulatory inspections by regulatory authorities and regular audits.
NewAssociate Director, Regulatory Affairs Advertising and Promotion Daiichi Sankyo, Inc.Associate Director, Regulatory Affairs Advertising and PromotionBasking Ridge, NJ$166,720–$250,080 / yearFull timeThe Associate Director, Regulatory Affairs Advertising and Promotion (RAAP) provides strategic and tactical regulatory support for U.S. promotional and selected non-promotional communications across assigned products, disease-state initiatives, and related external-facing materials within the Daiichi Sankyo portfolio. Partner with Medical, Legal, Compliance, Commercial, Clinical, Labeling, Public Affairs, Corporate Communications, Market Access, including alliance partners to support aligned, efficient, and compliant review of promotional materials.
NewSite Director at Parkway Elementary School KinderCare EducationSite Director at Parkway Elementary SchoolEwing Township, NJ$16.35–$33.15When you join our team as a Site Director, you will: Lead and supervise a group of teachers to create unique and engaging classroom experiences, leverage and develop “best in class” educators to be passionate and committed professionals. At KinderCare Learning Companies, the first and only early childhood education provider recognized with the Gallup Exceptional Workplace Award , we offer a variety of early education and child care options for families.
NewSite Director at Dr. Martin Luther King Jr. School No. 6 KinderCare EducationSite Director at Dr. Martin Luther King Jr. School No. 6Passaic, NJ$16.35–$33.15When you join our team as a Site Director, you will: Lead and supervise a group of teachers to create unique and engaging classroom experiences, leverage and develop “best in class” educators to be passionate and committed professionals. At KinderCare Learning Companies, the first and only early childhood education provider recognized with the Gallup Exceptional Workplace Award , we offer a variety of early education and child care options for families.
NewSite Director at Lore Elementary School KinderCare EducationSite Director at Lore Elementary SchoolEwing Township, NJ$16.35–$33.15When you join our team as a Site Director, you will: Lead and supervise a group of teachers to create unique and engaging classroom experiences, leverage and develop “best in class” educators to be passionate and committed professionals. At KinderCare Learning Companies, the first and only early childhood education provider recognized with the Gallup Exceptional Workplace Award , we offer a variety of early education and child care options for families.
NewSite Director at Bartle Elementary School KinderCare EducationSite Director at Bartle Elementary SchoolHighland Park, NJ$21.55–$30.20When you join our team as a Site Director, you will: Lead and supervise a group of teachers to create unique and engaging classroom experiences, leverage and develop “best in class” educators to be passionate and committed professionals. At KinderCare Learning Companies, the first and only early childhood education provider recognized with the Gallup Exceptional Workplace Award , we offer a variety of early education and child care options for families.
NewAssociate Director, Adjudication Operations Daiichi Sankyo, Inc.Associate Director, Adjudication OperationsBasking Ridge, NJ$171,120–$256,680 / yearFull timeThe Associate Director, Adjudication Operations will participate in all aspects of adjudication start-up activities, including but not limited to, compiling a committee membership, providing review and input into the Adjudication Committee Charter(s), developing the Adjudication Services Operational Plan, providing review and input into workflows and data capture forms, and providing input into the development of tracking tools and reports. Event case processing: intake and triage, event linking, event de-activation, tracking, data entry, document processing (e.g., redaction of specified content), review of incoming event information for completeness and accuracy, content review, identification of missing required data and/or documents, generation of queries, query review and closure/re-issue.
Director, Project Management & Business Excellence, CSPV Daiichi Sankyo, Inc.Director, Project Management & Business Excellence, CSPVBasking Ridge, NJ$193,040–$289,560 / yearFull timeChampions adoption of project management best practices and continuous improvement to strengthen CSPV operational excellence Business Excellence: Leads the development and implementation of operational excellence strategies in partnership with CSPV Leadership, aligning initiatives to business priorities and long-term goals. Leads and clearly articulates impact assessments of project outcomes—translating implications into actionable insights—while partnering with SMEs and leadership to shape implementation strategies and accelerate adoption.
Associate Director, Epidemiology Analytics Daiichi Sankyo, Inc.Associate Director, Epidemiology AnalyticsBasking Ridge, NJ$157,920–$236,880 / yearFull timeMaster's Degree in Biostatistics, Data Science, Statistics, Applied Mathematics, Epidemiology, or related field plus 7 years of experience in epidemiologic methods and data analysis (pharmaceutical industry in safety or associated service provider experience is preferred) required PhD in Biostatistics, Data Science, Statistics, Applied Mathematics, Epidemiology, or related field plus 4 years of experience in epidemiologic methods and data analysis (pharmaceutical industry in safety or associated service provider experience is preferred) preferred. Provide data management of diverse data (e.g., real-world setting and clinical trial) to set up epidemiologic data sets for various approaches, quantitative epidemiologic data analysis, interpretation of results, visualization of results, and generate manuscripts to disseminate findings.
Licensed Social Worker Assistant Director Care-OneLicensed Social Worker Assistant DirectorBound Brook, NJ$52,000–$72,000 / yearSocial Service functions include but are not limited to: supervising social service staff, direct services, advocacy, counseling, service coordination, education, in-servicing, policy and program development and community relations. Provide for therapeutic intervention to help residents cope with the social and psychological aspects of their illnesses, impairments, or disabilities as well as their feelings about institutionalization and separation from family, community, physical and emotional loss.
Assistant Director of Social Services Care-OneAssistant Director of Social ServicesMorristown, NJ$53,000–$70,000 / yearSocial Service functions include but are not limited to: supervising social service staff, direct services, advocacy, counseling, service coordination, education, in-servicing, policy and program development and community relations. Provide for therapeutic intervention to help residents cope with the social and psychological aspects of their illnesses, impairments, or disabilities as well as their feelings about institutionalization and separation from family, community, physical and emotional loss.
Associate Director, Global Oncology Marketing, Biomarker Strategy Daiichi Sankyo, Inc.Associate Director, Global Oncology Marketing, Biomarker StrategyBasking Ridge, NJ$162,400–$243,600 / yearFull timeCritical responsibilities include contribution to the brand plan, providing commercial input to CDx team, development of tactics such as education to laboratories/pathologists, drive quality initiatives, ensuring adequacy of testing supply in markets and coordinating all activities with regional teams. Apply expertise to challenge strategic and tactical assumptions and refine diagnostic strategies across the product lifecycle, considering competitive pressures, disease prevalence(s), test proficiency / quality assurance, and market access dynamics.
Executive Director, Global Clinical Lead Daiichi Sankyo, Inc.Executive Director, Global Clinical LeadBasking Ridge, NJ$329,025–$548,375 / yearFull timeProvides senior level clinical representation at meetings with health authorities; Leads the creation of developmental and regulatory strategy; Accountable for performance of CROs; Routine interactions with senior management of CRO/ARO, as needed; Accountable for clinical development plans, protocol profiles and sections of key submission documents; Represents Clinical Development as team leader or as supervisor of team leaders; Accountable for Clinical Development input into commercial strategy including Translational Medicine and biomarker strategy; Thought partner in driving Business Development decisions in collaboration with External Scientific Affairs dept. Study planning and execution: Develops prospective contingency plans for management of key risks across a large project or a portfolio of projects or across the Therapeutic Area; Clearly defines priorities and high level execution plans across projects within and outside of Daiichi Sankyo; Supports effective communication and decision-making process cross-functionally and cross-regionally at department level.
NewAssociate Director, Clinical Science Daiichi Sankyo, Inc.Associate Director, Clinical ScienceBasking Ridge, NJ$162,400–$243,600 / yearFull timeUnder supervision of Clinical Science Asset Lead or Clinical Science Lead, drafts development plans, protocol profiles, protocols, informed consent forms, and sections of submission documents. Advanced Technical Expertise: Possess advanced understanding of pre-clinical and clinical research, including protocol writing, data review, study design, and disease area knowledge preferred.
Director, Risk Based Quality Management (RBQM) Daiichi Sankyo, Inc.Director, Risk Based Quality Management (RBQM)Basking Ridge, NJ$201,840–$302,760 / yearFull timeOversee RBQM activities for Daiichi Sankyo Portfolio of Studies: Serve as senior level technical RBQM SME and oversee Central Risk Managers to ensure proper implementation and execution of RBQM and inspection readiness. Interacts with and influences internal and external executive level and study level stakeholders on risk based quality management principles, process improvement, metrics design and application and other key drivers of enhanced quality.
Director, Early Phase Biostatistics Daiichi Sankyo, Inc.Director, Early Phase BiostatisticsBasking Ridge, NJ$201,840–$302,760 / yearFull timeMentoring and Coaching Junior Statisticians: Mentoring the study level statisticians for the assigned projects to ensure optimal statistical handling and quality deliverables including Protocol Development, Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and Clinical Study Report (CSR). Drug Development Strategy: Provides input to the clinical development plan to ensure the overall strategy can deliver the pre-specified product profile, is logical, scientifically sound, proposed studies have appropriate designs, efficacy and safety information to be collected meet regulatory agencies’ requirements for countries and regions the drug is to be submitted.
Associate Director, Biostatistics (Late Stage) Daiichi Sankyo, Inc.Associate Director, Biostatistics (Late Stage)Basking Ridge, NJ$175,440–$263,160 / yearFull timeProtocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies including study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation and CSR input and review. May participate in meeting or teleconferences with Health Authorities Global BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve the harmonization and efficiency of drug development which leads to cost savings and shortened timelines for the company.
Associate Director PV Quality, Americas Daiichi Sankyo, Inc.Associate Director PV Quality, AmericasBasking Ridge, NJ$153,600–$230,400 / yearFull timeProvide operational QA leadership for the respective CSPV teams, including Quality Oversight for the Quality Plan execution, review of key CSPV regulatory documents, Health Authority Commitments, Critical Incidents including, respective escalation process and the CAPA Management Process for the respective CSPV functional areas. Interact with senior CSPV leadership teams to ensure Quality is consistently and proactively represented at program level and along the clinical trial process in support of a proactive quality risk management process.
NewSenior Director, Regulatory Affairs Clinical Dynamix, Inc.Senior Director, Regulatory AffairsJersey City, NJThe Senior Director will represent Company in key stakeholder and strategy meetings on regulatory matters related to medical product development and commercialization, including meetings with executive leadership, meetings with the Food and Drug Administration (FDA) and other regulators. The Senior Director, Regulatory Affairs is responsible for providing subject matter expertise on matters related to global regulatory activities, as well as providing leadership for the growth and responsibilities of the regulatory department.