Director, Clinical Study Management Eikon Therapeutics IncDirector, Clinical Study ManagementJersey City, NJ$203,000–$221,350 / yearEikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our Jersey City, New Jersey or Millbrae, California offices to ensure effective management and high-performance delivery of clinical studies.
Director, Clinical Quality Assurance GCP Eikon Therapeutics IncDirector, Clinical Quality Assurance GCPJersey City, NJ$204,000–$246,750 / yearEikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets. Lead quality management system (QMS) assessment for service providers and collaborate closely with Clinical Development Vendor Oversight team to ensure service provider qualification process is robust and timely.
Senior Manager, Commercial Forecasting and Insights Danaher CorpSenior Manager, Commercial Forecasting and InsightsNew York, NYRemote$115,000–$145,000 / yearThis role partners closely with Sales, Finance, and Commercial Excellence leadership to deliver high-confidence forecasts, actionable insights, and data-driven decision support that directly influence revenue outcomes and business strategy. The Senior Manager, Commercial Forecasting and Insights is responsible for owning and continuously improving the global forecasting ecosystem across orders, revenue, and commercial performance.
Quantitative Systems Pharmacology (QSP) Lead – Rare Disease Portfolio Shionogi Inc.Quantitative Systems Pharmacology (QSP) Lead – Rare Disease PortfolioFlorham Park, New Jersey$260,000–$295,000 / yearThis role serves as the scientific and strategic owner of QSP across high-priority programs, with responsibility for both building an end-to-end QSP operating model and delivering modeling outputs that inform clinical and development strategy. Develop and apply mechanistic and semi-mechanistic QSP models, including virtual patient simulations and in silico trials, to inform dose selection, trial design, and risk assessment, ensuring strong documentation, reproducibility, and scientific rigor.
Manager/Senior Manager, Statistical Programming Axsome TherapeuticsManager/Senior Manager, Statistical ProgrammingNew York, NYRemote$130,000–$155,000 / yearOur industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer's disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as multiple novel product candidates addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Develop programming specifications, programming quality check plans, and provide input on key study-related documents such as the SAP and TFL specifications (mock-ups/shells), as well as documents produced by other functions, such as Case Report Forms, Data Management Plans, and Data Transfer Specifications.
Payer Healthcare Data Scientist, Manager PwCPayer Healthcare Data Scientist, ManagerFlorham Park, NJ$99,000–$232,000 / yearAs part of the Operations Consulting team, you will apply advanced data science and machine learning techniques to large-scale claims, clinical, and member data to surface actionable insights that reduce cost of care and improve population health outcomes for our payer clients. PwC does not intend to hire experienced or entry level job seekers who will need, now or in the future, PwC sponsorship through the H-1B lottery, except as set forth within the following policy: https://pwc.to/H-1B-Lottery-Policy .
Associate Director, Direct-To-Consumer Innovation & Digital Health BeOne Medicines AGAssociate Director, Direct-To-Consumer Innovation & Digital HealthNY$155,800–$205,800 / yearGuided by our core values-putting patients first, driving excellence, fostering ingenuity, and collaborating across disciplines-we are building an ecosystem that unites breakthrough therapies with exceptional patient experiences. As Associate Director, DTC Innovation & Digital Health, you will define and lead the strategy for BeOne's next-generation customer experience technologies for individuals affected by chronic lymphocytic leukemia (CLL) and other hematologic malignances.
Veeva RIM Consultant Stark Pharma Solutions IncVeeva RIM ConsultantPiscataway, NJRemoteThe ideal candidate will have strong expertise in Veeva RIM, regulatory information management, and data quality, along with experience supporting digital transformation and automation initiatives within a regulated life sciences environment. We are seeking an experienced Veeva RIM Consultant to support regulatory data remediation and Veeva RIM initiatives for a leading pharmaceutical client.
North American Life Sciences Research Services Sales Director Oracle CorpNorth American Life Sciences Research Services Sales DirectorNY$148,900–$243,800 / yearSells and promotes the sales of Oracle research services to drive growth across Commercial, Real-World Evidence (RWE), Clinical, Regulatory, and Safety research services within pharmaceutical and biotechnology organizations. Oracle maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, market conditions and locations, as well as reflect Oracle''s differing products, industries and lines of business.
Associate Director, Health Authorities ImmunityBio IncAssociate Director, Health AuthoritiesSummit, NJCreate and maintain project plans for health authorities operations • Participate in cross-functional teams and provide support to others in the preparation, analysis, and documentation of studies • Lead external stakeholder engagement throughout the submission lifecycle, coordinating with CROs, external regulatory consultants, and subject matter experts / key opinion leaders to gather data, craft high‑quality RFI responses, and foster constructive agency relationships • Prepare and assign responses to Health Authority comments and questions pertaining to clinical issues. Education & Experience • Bachelors Degree in life sciences or technical discipline with 10+ years of relevant progressive experience required; or • Masters Degree in life sciences or technical discipline with 8+ years of relevant progressive experience required; or • Doctorate degree in life sciences or technical discipline with 6+ years of relevant progressive experience required.
Sr. Manager, Strategic Sourcing Jones Lang LaSalle IncSr. Manager, Strategic SourcingNewark, NJRemoteWe embrace more innovative ways of working and prioritize opportunities to strengthen and advance your career, providing you with exposure to diverse categories and senior leadership while building your influence across the organization as you partner strategically with C-suite clients and senior JLL leadership to deliver transformational and sustained value. Accountable for delivering sophisticated market intelligence, supplier analytics, and operational insights across services operations, you'll direct cross-functional teams and field resources to execute complex strategic initiatives with measurable business impact.
Principal Scientist, Regulatory CMC ImmunityBio IncPrincipal Scientist, Regulatory CMCSummit, NJBachelor's Degree in life sciences or technical discipline with 10+ years relevant progressive experience required; or • Master's Degree in life sciences or technical discipline with 8+ years relevant progressive experience required; or • Doctorate degree in life sciences or technical discipline with 6+ years relevant progressive experience required • Experience in the preparation of the submission of CMC modules in eCTD format required • Familiarity with organizing responses to Health Authority requests required • Familiarity with regulatory submissions outside of the US desired. ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells.
Manager, Regulatory Lifecycle Maintenance ImmunityBio IncManager, Regulatory Lifecycle MaintenanceSummit, NJImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.
Associate Director, Regulatory CMC ImmunityBio IncAssociate Director, Regulatory CMCSummit, NJImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. The Associate Director, Regulatory CMC will report to the Senior Director, Regulatory CMC and assist in the development of global Chemistry, Manufacturing and Control (CMC) regulatory strategy for investigational and marketed products and manage preparation of dossiers in eCTD format.
Senior Scientist, Regulatory CMC ImmunityBio IncSenior Scientist, Regulatory CMCSummit, NJImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. This position will support the development of submission strategies for CMC modules and updates, including life cycle management; and generation of submission-ready content for the Quality/CMC sections of all clinical trial and marketing authorization applications for ImmunityBio, Inc.
NewSenior Facilities Manager AzentaSenior Facilities ManagerSouth Plainfield, New JerseyWe are a market leader in automated bio sample management solutions and genomic services across areas such as drug development, clinical and advanced cell therapies for the industry's top pharmaceutical, biotech, academic and healthcare institutions globally. Ensure facilities operations are compliant with applicable safety, environmental, quality, OSHA, building code, and company requirements, including required documentation, inspections, corrective actions, and recordkeeping in partnership with QA, EHS, and site leadership.
Fullstack Lead Application Engineer Trinity Life SciencesFullstack Lead Application EngineerNew York, NY$148,000–$222,000 / yearTrinity's salary bands account for a wide range of factors that are considered in making compensation decisions including but not limited to skill sets and market demand for skills; level of experience and training; specific qualifications, performance, time in role/company, geographic location, and other business and organizational needs. Build, release, and iterate on new products/features that meet user requirements in collaboration with Product, UI/UX, and Data Science: Take ownership in building and/or refining a vertical of the technology product, setting direction in alignment with Engineering leadership.
Head Quality Systems and Compliance (Assoc Dir) Novartis AGHead Quality Systems and Compliance (Assoc Dir)East Hanover, NJ$138,600–$257,400 / yearAs a key member of the site Quality leadership team, you will drive a culture of compliance, continuous improvement, and operational excellence while ensuring inspection readiness and supporting the site''s long-term growth and transformation journey. Provide oversight of quality systems including deviations, corrective and preventive actions, exceptions, change controls, data integrity, eCompliance, key performance indicators, and key quality indicators.
Director of Research & Development Cresilon, Inc.Director of Research & DevelopmentBrooklyn, NY$160,000–$240,000Act as a technical thought leader overseeing a discovery/innovation efforts focused on materials and technologies, providing technical expertise and scientific direction to ensure new product development and applicable sustaining engineering projects are completed successfully to the committed schedule, product specifications and budgets established for the projects. Physical Requirements include the ability to get appropriate vaccinations and clearance to work in an OR/surgical environment, wear appropriate Personal Protective Equipment (PPE), be able to sit and stand, perform normal office work for moderate periods, and the ability to speak, listen, and understand verbal and written communication.
Senior Medical Device Research and Development Engineer Cresilon, Inc.Senior Medical Device Research and Development EngineerBrooklyn, NY$60,000–$160,000Maintain active dialogue with Regulatory Affairs as subject matter expert on all product design elements/documentation pertaining to research towards FDA/regulated authority submissions, Provide support to marketing and sales team, support the introduction of new technologies with the development of presentations, sales tools, formulations, and applications data. Exercise technical judgment in the design, execution, and interpretation of experiments within the scope of project responsibilities and ensure the use of professional concepts to solve complex problems in creative and effective ways, in conformance with scientific methods and procedures.