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Job Title: Coordinator Transplant Location: Main Hospital - New Brunswick Department Name: Organ Transplants Req #: 0000232611 Status: Salaried Shift: Day Pay Range: $109,000.00 - $135,000.00 per year Pay Transparency: The above reflects the anticipated annual salary range for this position if hired to work in New Jersey. The compensation offered to the candidate selected for the position will depend on several factors, including the candidate's educational background, skills and professional experience. Job Overview: RWJBH is seeking a highly dedicated Coordinator Transplant for our Cancer Center at our New Brunswick campus. The Coordinator Transplant coordinates information from referring physician, testing and clinic visits required for potential transplant recipient. Provides educational information to recipients, families, and caregivers regarding all aspects of transplantation including pre-transplant, operative procedure, post-operative management and monitoring, and long-term follow-up. In coordination with transplant physicians and surgeons, the Transplant Coordinator provides care to transplant recipients throughout all phases of transplantation including evaluation, wait-list, transplantation, and the post-transplant phase. Serves as the primary contact for patients, provides ongoing education to the patient and their supports, and monitors the patient status throughout the process. The Transplant Coordinator collaborates with all members of the transplant team, including physicians, surgeons, social workers, dietician, and pharmacists. Ensures that the responsibilities associated with the role are carried out in a manner that meets all regulatory requirements for a transplant program. RWJUH is an academic medical center with the largest pancreas transplant center in New Jersey. We have the resources to help patients with complex conditions that could be barriers to transplantation at other centers. Our partnership with Rutgers Robert Wood Johnson Medical School (RWJMS) means we have access to the latest research and clinical trials for state-of-the-art care. RWJUH’s program ranks first in New Jersey and second in the mid-Atlantic region in the number of pancreas transplants performed each year. Qualifications: Required: • Bachelors of Science in Nursing, • BLS and ACLS Certification, • Active New Jersey Registered Nurse License, • Day Shift, • Training, evaluation, and competencies for this role are overseen by a Clinical Manager to the department,, • The coordinator will be responsible for screening and educating potential and actual donors, • Reviews medication adjustments for post-transplant patients in collaboration with physicians and pharmacists, relays information to patients,, • Reviews outpatient lab values and testing results; works with physician/surgeon as needed to adjust care plan At RWJBarnabas Health, our market-competitive Total Rewards package provides comprehensive benefits and resources to support our employees’ physical, emotional, social, and financial health. • Paid Time Off (PTO), • Medical and Prescription Drug Insurance, • Dental and Vision Insurance, • Retirement Plans, • Short & Long Term Disability, • Life & Accidental Death Insurance, • Tuition Reimbursement, • Health Care/Dependent Care Flexible Spending Accounts, • Wellness Programs, • Voluntary Benefits (e.g., Pet Insurance) RWJBarnabas Health is the premier health care destination providing patient-centered, high-quality academic medicine in a compassionate and equitable manner, while delivering a best-in-class work experience to every member of the team. We honor and appreciate the privilege of creating and sustaining healthier communities, one person and one community at a time. As the leading academic health system in New Jersey, we advance innovative strategies in high-quality patient care, education, and research to address both the clinical and social determinants of health. RWJBarnabas Health aims to truly make a unique impact in local communities throughout New Jersey. From vastly improving the health of local residents to creating educational and career opportunities, this combination greatly benefits the state. We understand the growing and evolving needs of residents in New Jersey—whether that be enhancing the coordination for treating complex health conditions or improving community health through local programs and education. Equal Opportunity Employer

Hematologist Opportunity Astera Cancer Care East Brunswick/Monroe, NJ Job Details: Occupation: Physician Specialty: Hematology Clinic Location: East Brunswick/Monroe, NJ Employment: Full-Time Opportunity: Private Practice, Outpatient/Inpatient Board Certifications: BE/BC Degree: MD/DO Ideal Candidate: • Open to Fellows and Experienced Physicians About the Role: Astera Cancer Care is seeking a board-certified or board-eligible Hematologist with expertise in both malignant and benign hematologic disorders to join our dynamic and collaborative team. The ideal candidate will provide compassionate, evidence-based care to patients with a wide spectrum of hematologic conditions, including hematologic malignancies (e.g., leukemia, lymphoma, myeloma, and CAR-T) and non-malignant disorders (e.g., anemia, thrombocytopenia, sickle cell disease, bleeding/clotting disorders). About the Area: East Brunswick, New Jersey, offers a family-friendly suburban lifestyle with top-rated public schools, diverse communities, and convenient access to New York City and Philadelphia via major highways and public transit. Residents enjoy a mix of green spaces, parks, and recreational amenities like Crystal Springs Waterpark, along with a variety of shopping and dining options. The area is known for its safety and cultural richness, making it an attractive place for families and professionals. Recruitment Package: • Top-Tier Compensation: Benefit from highly competitive compensation structures. No cap on earning potential. Exact compensation may vary based on skills, experience, and location., • Professional Growth: Enjoy CME reimbursement to further your education and skills., • Comprehensive Benefits: Full employee benefits include: Medical, Dental, Vision, Short-Term and Long-Term Disability, Life, and Accidental Death., • Secure Future: Robust retirement savings plan., • Peace of Mind: We cover your malpractice insurance., • Future Stability: Partnership opportunity offered., • Work-Life Balance: Paid time off, to ensure you maintain a healthy work-life balance., • Community Care: Make a real difference by caring for patients in their local communities., • Career Advancement: Seize leadership opportunities for career growth within our organization., • Innovative Research: Enroll patients in cutting-edge clinical trials., • Academic Excellence: Present and participate in research at prestigious conferences., • Supportive Environment: Join a physician-led and managed organization that values clinical autonomy, work-life balance, and quality patient care while prioritizing your professional development and well-being. About the Practice and their Mission: Astera Cancer Care is a physician-owned multi-specialty community oncology practice delivering high-quality, coordinated, patient-centered cancer care. At Astera Cancer Care, their mission is to transform cancer care and the care and management of blood disorders with patient-focused, research-based treatment guided by compassion. Their team of multidisciplinary experts works together to improve the patient experience and provide efficient access to care, minimizing the clinical, financial, and emotional barriers that patients face. The practice offers Hematology/Medical Oncology, Breast Surgery, Palliative Care, Radiation Oncology, and Clinical Trials & Research Programs. Astera Cancer Care is a proud partner of OneOncology. OneOncology is a nationwide partnership of leading independent community oncology practices working together to improve the lives of everyone living with cancer with a physician-led, data-driven, technology-powered, and patient-centric model. Through OneOncology, partner practices have shared technology platforms that foster communication, data sharing, and clinical excellence across the network. OneOncology’s non-exclusive clinical trial site management subsidiary, OneR, delivers complex, multi-center clinical trials to affiliated practices. If you would like to apply or learn more about this opportunity, please email your CV to I look forward to speaking with you!

Urologist Opportunity Astera Urology East Brunswick, NJ Job Summary Occupation: Physician Specialty: Urology Clinic Location: East Brunswick, NJ Employment: Full-Time Opportunity: Private Practice, Outpatient/Inpatient Board Certifications: BE/BC Degree: MD/DO Experience Needed: • Residents, Fellows and Experienced Physicians encouraged to apply About the Role Astera Urology is seeking a dynamic Urologist to join our collaborative, multidisciplinary oncology team. The ideal candidate will provide compassionate, patient‑centered care across a diverse range of urologic conditions, including general urology, endourology, urologic oncology, and andrology & male reproductive medicine. This role offers the opportunity to perform and further develop expertise in robotic‑assisted urologic cancer surgeries, supported by a robust oncology infrastructure and a team‑based approach to care. The physician will work closely with medical oncology, radiation oncology, urology, primary care, rheumatology and advanced practice providers while managing a broad and engaging case mix. The position is designed with an excellent work‑life balance, and ER call is not required. Optional call opportunities are available for physicians seeking additional clinical involvement. About East Brunswick, NJ East Brunswick is located in central New Jersey and offers a welcoming, family-friendly community with highly rated schools, shopping, and convenient access to both New York City and Philadelphia via major highways and public transit. The area is close to New Brunswick, a vibrant university town known for its diverse cultural scene, including theater, performing arts, fine dining, and collegiate athletic events at nearby stadiums. Popular New Jersey shore destinations are also within easy driving distance. What We Offer Top-Tier Compensation – No cap on earning potential Comprehensive Benefits – Medical, Dental, Vision, Disability, Life Retirement Plan – Secure your future, 401k match Work-Life Balance – Paid time off Professional Growth – CME reimbursement, leadership opportunities Research & Innovation – Access to clinical trials and cutting-edge technology About Astera Cancer Care Astera Cancer Care is a physician-owned multi-specialty community oncology practice delivering high-quality, coordinated, patient-centered cancer care. At Astera Cancer Care, their mission is to transform cancer care and the care and management of blood disorders with patient-focused, research-based treatment guided by compassion. Their team of multidisciplinary experts works together to improve the patient experience and provide efficient access to care, minimizing the clinical, financial, and emotional barriers that patients face. The practice offers Hematology/Medical Oncology, Breast Surgery, Palliative Care, Radiation Oncology, and Clinical Trials & Research Programs. Astera Cancer Care is a proud partner of OneOncology. OneOncology is a nationwide partnership of leading independent community oncology practices working together to improve the lives of everyone living with cancer with a physician-led, data-driven, technology-powered, and patient-centric model. Through OneOncology, partner practices have shared technology platforms that foster communication, data sharing, and clinical excellence across the network. OneOncology’s non-exclusive clinical trial site management subsidiary, OneR, delivers complex, multi-center clinical trials to affiliated practices. If you would like to apply or learn more about this opportunity, please email your CV to I look forward to speaking with you!

Director of CAR-T Cell Therapy Astera Cancer Care East Brunswick/Monroe, NJ Job Details: Occupation: Physician Specialty: Hematology Clinic Location: East Brunswick/Monroe, NJ Employment: Full-Time Opportunity: Private Practice, Outpatient/Inpatient Board Certifications: BC Degree: MD/DO Ideal Candidate: • Early to mid-career clinical researcher with a strong background in providing direct patient care and conducting clinical research in CAR-T Cell Therapy, • Leadership opportunity for someone who is passionate about advancing cutting-edge cellular therapies in oncology About the Role: Astera Cancer Care is seeking a Director of CAR-T Cell Therapy to conduct clinical research and manage patients. This includes overseeing patient selection, treatment planning, and post-infusion care to ensure optimal outcomes. The Director will lead a multidisciplinary team of nurses, pharmacists, and coordinators, fostering collaboration across all aspects of care delivery. In addition to clinical responsibilities, the role balances strategic oversight with program development, quality assurance, and operational planning. About the Area: East Brunswick, New Jersey, offers a family-friendly suburban lifestyle with top-rated public schools, diverse communities, and convenient access to New York City and Philadelphia via major highways and public transit. Residents enjoy a mix of green spaces, parks, and recreational amenities like Crystal Springs Waterpark, along with a variety of shopping and dining options. The area is known for its safety and cultural richness, making it an attractive place for families and professionals. Recruitment Package: • Top-Tier Compensation: Benefit from highly competitive compensation structures. No cap on earning potential. Exact compensation may vary based on skills, experience, and location., • Professional Growth: Enjoy CME reimbursement to further your education and skills., • Comprehensive Benefits: Full employee benefits include: Medical, Dental, Vision, Short-Term and Long-Term Disability, Life, and Accidental Death., • Secure Future: Robust retirement savings plan., • Peace of Mind: We cover your malpractice insurance., • Future Stability: Partnership opportunity offered., • Work-Life Balance: Paid time off, to ensure you maintain a healthy work-life balance., • Community Care: Make a real difference by caring for patients in their local communities., • Career Advancement: Seize leadership opportunities for career growth within our organization., • Innovative Research: Enroll patients in cutting-edge clinical trials., • Academic Excellence: Present and participate in research at prestigious conferences., • Supportive Environment: Join a physician-led and managed organization that values clinical autonomy, work-life balance, and quality patient care while prioritizing your professional development and well-being. About the Practice and their Mission: Astera Cancer Care is a physician-owned multi-specialty community oncology practice delivering high-quality, coordinated, patient-centered cancer care. At Astera Cancer Care, their mission is to transform cancer care and the care and management of blood disorders with patient-focused, research-based treatment guided by compassion. Their team of multidisciplinary experts works together to improve the patient experience and provide efficient access to care, minimizing the clinical, financial, and emotional barriers that patients face. The practice offers Hematology/Medical Oncology, Breast Surgery, Palliative Care, Radiation Oncology, and Clinical Trials & Research Programs. Astera Cancer Care is a proud partner of OneOncology. OneOncology is a national partnership of leading independent community oncology practices working together to improve the lives of everyone living with cancer with a physician-led, data-driven, technology-powered, and patient-centric model. Through OneOncology, partner practices have shared technology platforms that foster communication, data sharing, and clinical excellence across the network. OneOncology’s non-exclusive clinical trial site management subsidiary, OneR, delivers complex, multi-center clinical trials to affiliated practices. If you would like to apply or learn more about this opportunity, please email your CV to I look forward to speaking with you!

Job Title: Manager, Vendor Outsourcing Location: Parsippany, NJ (HM Site); Foster City, CA; Santa Monica, CA Duration: 12 months Hybrid: Onsite 3 days a week - T/W/Th Functional Area: Development Operations, Vendor Outsourcing Position Type: Full Time Equivalent Department: Vendor Outsourcing Client is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. As part of our rapidly growing science-driven organization, colleagues at client are revolutionizing healthcare by bringing urgently needed medicines to patients in the areas of Virology, Inflammation and Oncology conditions. We are proud to have some of the most talented colleagues from across the research, healthcare, pharmaceutical, biotechnology & business sectors, working together and supporting each other to help make a real difference to the lives of patients. Client is currently seeking an industry leader for Manager, Vendor Outsourcing within our Development Business Operations department. The Manager will have the opportunity to lead sourcing and contracting for full service CRO contracts within Oncology. This position will be responsible to develop and maintain sourcing plans, as well as sourcing events and contracting in a clinical research environment. This role will be responsible for the sourcing, contracting, including, facilitating vendor selection, RFI, RFP, contracting, and qualification with a focus on CRO services outsourced in support of client clinical trials. The core responsibilities and skills required for this position include but is not limited to: Delivery Excellence • Is an expert in contract management and had a history of implementing and executing category roadmaps and sourcing plans, • Develops global clinical development vendor strategy for a program or therapeutic areas, • Manages contract and sourcing activities for clinical development programs providing consistent customer service and delivering quantitative value through cost savings and transformation/innovation, • Manages the contract negotiation process across the entire life cycle including RFI, vendor identification, RFP, vendor selection decision, contracting negotiation, performance monitoring, change orders, and ensures proper closeout of agreements to maximize contract value and achieve target savings, • Ensure the vendor selection process is compliant by managing risks, • Partners with other functions such as Compliance, Legal and Regulatory as necessary, • Collaborates with internal customers in vendor bidding and proposal development (RFP creation and analysis), • Partners with internal customers to develop study specifications and leverages benchmarking tools as appropriate, • Translates business requirements into vendor capabilities and develops recommendations for vendor selection for a program or therapeutic area, • Is an SME in resolving complex issues relating to contract negotiation and management?, • Oversees the identification, selection and management of global external service providers, • Leads Vendor bid defense meetings, • Manages the contract negotiation process for complex or high value contracts, • Demonstrates strong understanding of regulatory and legal issues pertinent to clinical development, • Is project focused and works with a sense of urgency Strategic Thinking • Ability to understand, analyze and develop recommendations from multiple complex sources such as financial and operational perspectives, • Influence vendor selection with stakeholders at the project team level Innovation • Identifies, develops, and deploys best practices in vendor selection, cost containment, and category management practices, • Leverages prior experience with external benchmarking, industry best practices, and technology for continuous improvement Problem Solving • Takes ownership of issues from problem identification to successful resolution, testing recommendations for reasonableness, • Triages study-level vendor management issues; escalates high-risk issues to appropriate stakeholders, • Translates trends in operational and systematic issues and develops solutions with sustainability in mind to ensure roadblocks are removed during study start-up Influence and Partnership • Engage with study team leadership to drive sourcing strategy, compliance, and continued partnership, • Exhibits competency in regularly establishing relationships with internal and external cross functional teams, such as clinical operations, legal, finance, compliance, • Partners with internal stakeholders working on contracts in resolving complex issues relating to contract negotiation or management, • Manages study level vendor relationships in conjunction with Clinical Operations Decision Making • Delivers value by developing business solutions by translating requirements into effective sourcing solutions, contractual terms and process improvements, • Asks probing questions to uncover business needs and recommends solutions (e.g., negotiating timelines while maintaining standards), • Demonstrated ability to make critical decisions related to clinical vendor agreement negotiations and escalations, • Consolidates data across functions according to business requirements and recommends vendors to senior leadership for endorsement, • Resolves vendor project management issues (e.g., operational challenges including scoping issues) by identifying and addressing deviations from established protocols, • Identifies operational and systematic issues, including frequency and escalates to the appropriate level Communication • Excellent communication skills and comfort level interacting with internal and external teams across all levels, including regular interface with stakeholders and leadership team members, • As necessary, trains internal stakeholders in contract budgeting, development, and administration Capabilities and Requirements • Experience in providing thought leadership and consistent customer service, • Expertise in the end-to-end sourcing and contracting process, including RFx, contract negotiation and change order management, • Demonstrates an in-depth knowledge of the clinical research process and the regulatory environment across functions, • Demonstrated leadership skills while working in fast paced and changing environment, • Financial acumen to review, analyze and understand cost drivers of complex budgets, • Legal, clinical operations and regulatory acumen Knowledge, Experience and Skills: • Relevant experience with a BA or MS in a relevant discipline, • MBA or JD preferred, • PMP/CPSM certification or equivalent a plus, • 5+ years of relevant experience

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life's moments for children and adults living with a rare disease. At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging. Visit our website to learn more about our company and culture! Site: ___ The Senior Vice President, Clinical Development is responsible for providing strategic leadership for the clinical/medical aspects of all phases of drug development across all therapeutic areas, compounds and/or indications. The incumbent is accountable for ensuring that clinical trials and protocols are properly designed and executed in accordance with applicable Good Clinical Practice (GCP) regulations. He/she is also accountable for defining and leading the strategic design of programs/studies such that there is strategic alignment across the portfolio. The role provides oversight for the analysis of study results, the assessment of the extent to which the study(ies) has achieved clinical and regulatory objectives, and the documentation of study results. This includes, but may not be limited to, overseeing the activities of the Clinical organization. The incumbent is a key representative of PTC's clinical development organization in meetings with external stakeholders and audiences as needed; he/she may also author, or review for scientific/ medical purposes, clinical/medical-related materials intended for internal and/or external audiences. He/she manages direct and indirect reports. The incumbent works cross-functionally with internal departments and external resources on Clinical Development related issues. The Senior Vice President, Clinical Development is accountable for adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. . ESSENTIAL FUNCTIONS Primary duties/responsibilities: * Provides strategic and technical guidance and leads the global clinical development strategy for all therapeutic areas, compounds, and/or indications from pre-IND registration through late stage clinical development (which may include post-registration required studies) ensures the design of Clinical Development Plans (CDPs) to enable PTC to: 1) demonstrate clinical/medical benefit(s) and 2) achieve compound and business objectives; provides clinical/medical input to non-clinical and commercial functions on matters related to these objectives. * Directs relationships with external partners (e.g. vendors, consultants, collaborators, etc.); monitors program/study budgets to ensure the timely and cost-effective implementation of CDP(s); reviews and approves contracts, work orders, and invoices within grant of authority; participates in the assessment of CROs, vendors, consultants or other partners as necessary. * In partnership with the Development Leadership Team, contributes to ensuring all Development functions are, and remain, strategically aligned to the company's goals and to Development's objectives. * Provides input into Clinical Development oversight through the Development Leadership Review meetings * Partners with other core functions (e.g. Clinical Operations, Regulatory Affairs, Pharmacovigilance and Biostatistics/Data Management, etc...) to ensure that clinical development activities are defined and executed in a manner that is compliant and achieves clinical and regulatory milestones. * Facilitates communication and collaboration with internal, cross-functional team members (e.g. research, manufacturing, drug supply, regulatory, quality, project management, marketing, domestic and international regulatory authorities, etc.) to support CDPs, regulatory submissions and corporate goals. * Ensures adherence to the highest scientific, ethical, and regulatory standards and ensures compliance with all applicable GCP regulatory requirements. * May represent PTC's Clinical development team in meetings with external collaborators regarding the status of partnered clinical development projects. * May support the assessment of in-licensing product candidates in area of expertise, as needed. * Interacts with Health Authorities including, but not limited to, Food and Drug Administration (FDA) and European Medicines Agency (EMA). * Manages, coaches and mentors direct and indirect reports. * Performs other tasks and assignments as needed and specified by management. KNOWLEDGE/SKILLS/ABILITIES REQUIRED • Minimum level of education and years of relevant work experience. MD degree and a minimum of 12 years progressively responsible and strategic experience in clinical drug development (minimum of 6 years in a clinical leadership role) in a pharmaceutical, biotechnical, CRO or related environment and/or a minimum of 12 years of related professional experience in these same environments. • Special knowledge or skills needed and/or licenses or certificates required. Strategic vision-setting abilities coupled with entrepreneurial, hands on approach. * Excellent, hands-on clinical trial design leadership and data interpretation experience. * Thorough working knowledge across a broad range of areas of drug development. * Hands-on New Drug Applications (NDAs)/Marketing Authorization Applications (MAA) submission experience. * Hands-on experience successfully developing, registering, and supporting compounds throughout their lifecycle. * Regulatory experience; significant interaction with health authorities within and outside of the U.S. (FDA, EMA, PMDA, etc.) * Hands-on experience managing multiple therapeutic areas and/or compounds. * Demonstrated leadership ability and experience managing, coaching and mentoring direct reports. * Ability to influence without direct authority. * Proficiency with Microsoft Office. * Excellent verbal and written communication and skills. Must have the ability to interface professionally with a wide spectrum of internal and external academicians, agencies, and industry executives in the scientific/medical arena. * Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members. * Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines. * Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects. *Special knowledge or skills and/or licenses or certificates preferred. * Global experience. * Experience working in rare/orphan disease research. • Travel requirements Up to 40% Expected Base Salary Range $425,000 - 485,000. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity. In addition to base salary, PTC employees are also eligible for short- and long-term incentives.All eligible employees may also enroll in PTC's medical, dental, vision, and retirement savings plans. EEO Statement: PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

Job DescriptionBenefits/Perks • Highly enriched & healthy work environment, • Excellent growth opportunities, • Competitive Pay Position Summary The Quality Assurance Specialist Clinical Trial Supply plays a critical role in ensuring the quality, safety, integrity, and compliance of clinical trial materials throughout their lifecyclefrom receipt and storage to packaging, labeling, distribution, and returns. This role supports GxP operations, oversees Quality System activities, and collaborates cross-functionally with Operations, Warehouse, Packaging, Project Management, and external suppliers/CROs to maintain compliance with FDA, EU-GMP, GDP, ICH-GCP, DSCSA, and internal JRS standards. The QA Specialist ensures that all products and processes meet regulatory and customer expectations while supporting JRSs mission to deliver reliable, resilient, and high-quality clinical supply solutions worldwide. Key Responsibilities 1. Quality Systems & Compliance • Ensure compliance with GMP, GDP, GCP, ICH, FDA, EMA, MHRA, TGA, CDSCO and JRS internal SOPs., • Review, approve, and maintain controlled documents including SOPs, Work Instructions, Forms, Batch Records, Labeling Specs, and Packaging Records., • Support implementation and continuous improvement of Quality Management Systems (QMS) including Deviation Management, CAPA, Change Control, Training, and Document Control., • Participate in internal audits, customer audits, vendor qualifications, and regulatory inspections. 2. Clinical Supply Chain Quality Oversight • Perform QA review and approval of:, • Incoming clinical supplies (comparator drugs, IMPs, ancillary supplies), • Packaging and labeling activities, • Storage and temperature monitoring records, • Distribution documentation including shipping records, AWBs, and temperature logger data, • Verify completion and accuracy of Line Clearance, Batch Packaging Records (BPR), and Label Control Logs., • Review and approve EPCIS/DSCSA traceability files, CoA/CoC, pedigrees, and other regulatory documentation. 3. Investigations & Deviation Management • Lead or support investigations for:, • Temperature excursions, • Packaging or labeling discrepancies, • Shipment issues, • Supplier or customer complaints, • Perform root cause analysis (RCA), risk evaluation, and implement effective CAPAs. 4. Vendor & Customer Quality Support • Support supplier qualification by reviewing:, • GMP/GDP licenses, • ISO certifications, • Quality Agreements (QTA), • Questionnaires and risk assessments, • Collaborate with customers to ensure project-specific quality requirements are met. 5. Documentation & Regulatory Support • Ensure accurate completion of QA documentation related to:, • Clinical supply release, • Temperature-controlled shipping, • Storage of controlled and non-controlled materials, • Destruction, return, and reconciliation, • Maintain updated Quality and Technical Agreements (QTA) with clients and suppliers. 6. Training & Continuous Improvement • Deliver and maintain training programs for QA and Operations teams on:, • GDP/GMP compliance, • SOP revisions, • Packaging and labeling quality requirements, • Temperature control best practices, • Participate in continuous improvement initiatives to enhance operational efficiency and compliance. Required Qualifications • Bachelors degree in Life Sciences, Pharmacy, Biotechnology, Chemistry, or related field., • 25 years of experience in Quality Assurance within Clinical Trial Supply, Pharmaceutical, Biotech, CRO, CDMO, or GMP/GDP warehouse environment., • Strong understanding of GMP, GDP, GCP, DSCSA/EPCIS, ICH guidelines, and clinical supply chain processes., • Experience with deviations, CAPA, change control, labeling review, packaging operations, and QA release. Preferred Qualifications • Experience working with temperature-controlled logistics (28C, -20C, CRT)., • Knowledge of comparator sourcing workflows and global distribution practices., • Familiarity with Quality Agreements, Supplier Qualification, and Vendor Audits., • Experience with Power BI, SharePoint QMS, and ERP/WMS systems., • Certification in GMP/GDP/GCP (optional but advantageous). Core Competencies • Strong attention to detail and documentation accuracy., • Excellent communication and problem-solving skills., • Ability to work cross-functionally and manage multiple priorities., • Proactive, organized, and committed to quality and compliance., • Ability to make decisions based on risk, data analysis, and regulatory expectations. Why Join Jupiter Research Services? • Work in a rapidly growing organization focused on resilient clinical supply chain solutions., • Gain exposure to global clinical trials, high-impact projects, and innovative supply models., • Contribute to a compliance-driven organization with strong customer and patient-centric values., • Opportunities for growth in Quality, Operations, Regulatory, and Project Management.

Job Description Company Overview: We are a dynamic and innovative small biotechnology company dedicated to advancing oncology research through cutting-edge translational science. Our mission is to translate scientific discoveries into tangible therapeutic solutions that make a meaningful impact on cancer patients' lives. We are seeking a talented and motivated Translational Scientist to join our team and contribute to our mission-driven work. Position Overview: As a manager of clinical pharmacology you will be responsible for providing clinical pharmacology input in early (up to proof-of-concept stage) and late-stage clinical development. You will be responsible for representing clinical pharmacology function on drug development teams, providing input on the dose and the design of early and late-stage clinical trials, and for interacting with the clinicians and the clinical operations group for the execution of the clinical pharmacology components (PK, PD, biomarkers, etc) of the trials. In addition, you will be responsible for performing clinical PK/PD analyses, for providing subject matter leadership related to clinical ADME, pre-clinical to clinical extrapolation and selection of dose/regimen during early development. Additionally, you will be responsible for providing input on study design and leading the selection of doses for late-stage clinical studies. You will contribute to the preparation of the regulatory documents such as briefing books for pre-agency meetings, IBs, INDs, and IMPD dossiers, protocols, and clinical study reports. You will closely collaborate with other development-functions (Toxicology, Bioanalytical, Non-clinical PK/PD, Pharmacometrics and Physiological PK/PD Modeling and Simulation, Biomarkers, Biostatistics and Data Management, Clinical Operations, and Clinical Development) to bring drug candidates from IND stage to NDA. You will be responsible for working within the department level budget and resources. Support technical due diligence efforts for business development. Responsibilities: • Responsible for providing support for the preparation of the clinical pharmacology (PK, biomarkers, bioanalytical) sections of early and late-stage clinical protocols, Clin Pharm development plans, modeling & simulation plans, • Contribute to the preparation of the pre-IND, IND, IB and NDA/BLA documents, • Responsible for the pharmacokinetic and PK/PD data analyses using standard industry data analysis software, • Contribute to the design of early phase clinical trials (FIH to POC) and support project goals, • Responsible for recommending the starting dose in FIH trials based on allometric scaling or physiologically based PK modeling, • Conduct assessments of relevant exposure vs. response data for supporting dose selection during and post POC, • Contribute to the design of late-stage clinical trials (POC-NDA/BLA) and support project goals, • Responsible for leading the dose selection for Phase II and III clinical trials based on PK, PD biomarker and efficacy data analysis from previous studies., • Responsible for the preparation of the PK/PD reports and clinical study reports, • Represent Clin Pharm function for the project team at the regulatory agencies during regulatory meetings., • Provide clinical pharmacology input and collaborate across all areas of drug development, along with research, preclinical, bioanalytical and clinical development functions., • Provide oversight to vendors and ensure high quality deliverables that meet study/project timelines, • 3+ years of pertinent post-doctoral experience in supporting pharmacokinetics, pharmacodynamics and other clinical pharmacology components of early clinical trials within the pharmaceutical or biotech industry., • Exposure to biologics drug development. Knowledge of basic and clinical immunology is plus., • Hands on knowledge of PK/PD and statistical analyses methods used in analyzing early clinical phase data., • Knowledge of general regulatory process and experience in contributing to IND, EOP1, EOP2, and pre-BLA/NDA meetings with the FDA , EMA and other health authorities., • Excellent written and oral communication skills including good presentation skills. Qualifications: • Doctoral degree (PhD or Equivalent training by experience) in clinical pharmacology, pharmacokinetics, pharmacology, or relevant life science discipline such as biology, immunology., • Hands-on experience with pharmacokinetic/pharmacodynamic data analyses using standard industry data analysis software., • Familiar with PK/PD concepts. principles and applications to support prospective dose/regimen recommendations for planned Phase 1, 2 and 3 trials., • Experience in preparing clinical pharmacology components of clinical study protocols and clinical study reports., • Knowledge of current practices and issues in the bioanalytical and drug metabolism areas., • Proficient in the use of Microsoft Word, Excel and PowerPoint. Travel: • Ability to travel domestic and internationally ≤ 20%. Benefits: Competitive salary commensurate with experience Comprehensive benefits package, including medical, dental, and vision coverage Opportunities for career growth and professional development Collaborative and dynamic work environment with a diverse team of scientists and clinicians Opportunity to make a meaningful impact on cancer patients' lives through innovative translational research

Job DescriptionOVERVIEW: Vitalief is a trusted partner working at the intersection of Sites, Sponsors, and CROs across the research and clinical trials landscape. By blending deep subject matter expertise with strong business acumen, we deliver consulting (both operational and strategic) and Functional Service Provider (FSP) solutions that empower organizations to do more with less, streamlining operations, reducing costs, and accelerating breakthroughs that ultimately benefit patients. We are seeking a problem-solving, “hands-on” Grants Manager to join our exceptional client team. WHY VITALIEF? • You can actively contribute to our clients’ mission of advancing scientific discoveries that have the potential to change patients' lives for the better., • Our PEOPLE FIRST culture prioritizes personal and professional growth for all Vitalief employees., • We give everyone a seat at the table – we encourage innovation., • Life/work balance that includes 20 PTO (Paid Time Off) days plus 9 paid Holidays annually. Work Location: Hybrid; Occasional travel to New Brunswick, NJ. Responsibilities: • Provide oversight and management of project timelines, sponsor requests, budget preparation, and deliverables. Participate in grant project meeting coordination and meeting management. Support the preparation and processing of proposals, acceptance of awards, and negotiation of agreements, including subawards., • Oversee data management plans and ensure procedures are effectively communicated within the team while ensuring accuracy and confidentiality., • Serve as a liaison between project stakeholders, including the Principal Investigator/research team, central administrative offices and regulatory bodies, and external collaborators, such as sub-recipients and vendors, on administrative issues, identifying solutions for exceptional circumstances and resolve problems at all stages of the sponsored programs lifecycle., • Advise and/or assist research team on the procurement of supplies and other necessary grant items and categorizing under the appropriate grant., • Minimum of 5 years of grants management experience with emphasis on NIH sponsored grants, • Bachelors degree in a related field (e.g., life sciences, public health, healthcare administration)., • Membership in American Association of Grant Professionals and/or National Grants Management Association or an equivalent preferred., • Strong leadership and project management skills., • Demonstrated experience building positive relationships and working effectively with PI’s, all levels within the client organization, as well as external grantor agencies and subcontracting institutions, ensuring successful and timely grant submission., • Experience with the following: preparing and/or reviewing administrative material for grant submissions; budget forecasting and management; ongoing monitoring of fund statements; financial management and monitoring of awarded grants, resolution of accounting problems/errors; functioning as a liaison to federal and non-federal grantor agencies and subcontracting institutions; monitoring grants and contracts for compliance issues., • Critical thinking and decision-making skills – ability to evaluate all aspects of a situation and to independently make appropriate and timely decisions., • Excellent oral and written communication, presentation and interpersonal skills. #LI-DNP Powered by JazzHR Zp8RtaZLYW

Job DescriptionTHE ROLE We are seeking an experienced Oncology Registered Nurse to join Vitalief as a full-time, fully benefited employee supporting a leading research center in New Brunswick, NJ conducting high-priority interventional oncology clinical trials across multiple disease areas. This role is an excellent opportunity for oncology nurses who want to transition into clinical research but may not have prior research experience. Clinical research training will be provided, making this a strong entry point into the clinical trials and research field while allowing you to continue working with oncology patients. WHY CLINICAL RESEARCH AND VITALIEF? • Training provided - no prior research experience required., • Stay in oncology while transitioning into a new career path in clinical research., • Predictable schedule: Monday–Friday, 8:00 AM – 4:30 PM (no nights, weekends, or holidays)., • Work on cutting-edge cancer treatments and clinical trials that improve patient outcomes., • More autonomy and critical thinking compared to task-based nursing roles., • Professional, collaborative environment working directly with physicians and research teams., • Less physical demand than many bedside roles., • Competitive benefits: including 20 PTO days + 9 paid holidays; Company-paid life insurance and short/long-term disability; 401(k) retirement program; Comprehensive healthcare plans., • Support Phase II–III Medical Oncology interventional clinical trials (drug and biologic studies, with some device, radiation, and surgical components), focused on head, neck and lung cancer trials., • Provide compassionate, patient-facing oncology nursing care while ensuring study protocols and Good Clinical Practice (GCP) guidelines are followed., • Assist investigators with study start-up and ongoing trial activities, including patient screening, consenting, enrollment, and protocol-driven patient management., • Serve as a clinical research partner to physicians and study teams, ensuring protocol compliance, patient safety, and accurate documentation., • Coordinate with departments including pathology, radiology, laboratory, surgery, and infusion services., • On clinic days, provide direct patient support; on non-clinic days, complete documentation, patient follow-up, order review, and study coordination activities., • Assist with clinical trial activation and study start-up activities using OnCore™., • Review medical records for protocol eligibility and collect required source documentation., • Active Registered Nurse (RN) license in the State of New Jersey., • Bachelor of Science in Nursing (BSN) required., • Minimum 3 years of nursing experience (hospital, outpatient, or clinic setting)., • At least 1 year of oncology nursing experience., • Clinical research experience is a plus but not required (training provided)., • Strong critical thinking, organization, and prioritization skills., • Combines compassion with strong patient education skills to guide study participants through complex treatment protocols and clinical trial participation., • Ability to work independently and collaboratively with physicians and research teams., • Strong communication skills and attention to detail. IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis. Powered by JazzHR 2jSciN12is

Job DescriptionTHE ROLE Vitalief is seeking an Oncology Registered Nurse to support interventional cancer clinical trials at a leading research center in New Brunswick, NJ. This position is ideal for oncology nurses currently working in direct patient care roles, whether in a hospital or outpatient setting, who are interested in transitioning into clinical research. This is a growing and in-demand specialty, and training will be provided to support your transition. In this role, you will continue working with oncology patients while applying your clinical expertise in a structured, professionally focused research environment. WHY CLINICAL RESEARCH AND VITALIEF? • Predictable schedule: Monday - Friday, 8:00 AM - 4:30 PM (no nights, weekends, or holidays)., • Market-competitive salary: $95,000 to $115,000 (depending on experience), • Stay in oncology while transitioning into a new career path in clinical research., • Training provided: no prior research experience required., • Less physical demand than many bedside roles., • Competitive benefits: including 20 PTO days + 9 paid holidays; Company-paid life insurance and short/long-term disability; 401(k) retirement program; Comprehensive healthcare plans., • Support Phase II–III oncology clinical trials (drug, biologic, and some device studies) in head & neck and lung cancer., • Screen, consent, and enroll patients onto clinical trials., • Educate patients and guide them through their clinical trial treatment journey., • Coordinate care with physicians, infusion, radiology, pathology, and lab teams., • Monitor patients for side effects and report Serious Adverse Events., • Manage study documentation, patient calendars, and research records., • Participate in study start-up and trial activation activities. QUALIFICATIONS, • Active RN license in the state of New Jersey., • BSN degree required., • 3+ years of nursing experience (preferably in a (hospital, outpatient, or clinic settings)., • 1 or more years of oncology experience., • Strong interest in clinical research (no experience required - training will be provided)., • Strong patient education, organization, and communication skills. IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis. Powered by JazzHR GOGp1qzydB

Job DescriptionABOUT VITALIEF Vitalief is a consulting and professional services firm that partners with clinical research sites, sponsors, and CROs to enhance trial activation, operational performance, and workforce readiness. Our approach combines deep clinical research expertise with operational excellence and business acumen, enabling organizations to work more efficiently. We help clients streamline processes, reduce costs, accelerate timelines, and ultimately improve patient outcomes. THE ROLE We are seeking an experienced Clinical Research Nurse to join our team as a full-time Vitalief employee. In this role, you will support one of our clients who is an outpatient cancer center attached to hospital in the New Brunswick, NJ area, overseeing high-priority interventional oncology clinical trials across multiple disease groups. This is an exciting opportunity for an experienced nurse (RN) to transition into a rewarding career in clinical research and support Oncology trials. Our client is willing to provide comprehensive on the job training in oncology and clinical trials. WHY VITALIEF? • Contribute to advancing scientific discoveries: that improve patient lives., • PEOPLE FIRST culture: with opportunities for growth and innovation., • Competitive benefits: include 20 PTO days + 9 paid holidays; Company-paid life insurance and short/long-term disability; 401(k) retirement program; Comprehensive healthcare plans., • Work schedule: 5 days per week on-site (New Brunswick, NJ area) initially; then 4 days on-site and 1 day remote weekly after the training period., • Standard work hours: 8:00am to 4:30pm., • Under the direction of the Clinical Research Director, support primarily Medical Oncology interventional studies (Phase II–III). Studies are largely drug and biologic trials, with limited device studies, and may include radiation and surgical components., • Deliver high-quality, compassionate, hands-on oncology nursing care while coordinating closely with investigators, clinical teams, and ancillary departments (e.g., pathology, radiology, clinical laboratory, surgery, infusion services) in accordance with study protocols, treatment plans, and Good Clinical Practice (GCP) guidelines., • Assist investigators with the preparation and implementation of new clinical trials, including patient screening, enrollment, and ongoing protocol-driven clinical management of study participants., • Serve as a critical-thinking clinical partner—not a task-based nurse—demonstrating the ability to prioritize, exercise sound judgment, and appropriately challenge physician orders to ensure protocol accuracy, patient safety, and completeness of documentation., • Work within assigned physician groups aligned to clinic schedules. On clinic days, provide direct patient-facing support; on non-clinic days, complete administrative and project-related activities such as documentation, patient follow-up calls, order review, and study coordination., • Collaborate with the Protocol Activation Office to initiate and activate assigned clinical trials using the OnCore™ study start-up task list., • Review patient charts and medical histories to confirm protocol eligibility and obtain required source documentation., • Graduate of an accredited school of nursing with an active Registered Nurse (RN) license in the State of New Jersey., • Bachelor of Science in Nursing (BSN) required., • Minimum 5 years of nursing experience in a hospital or outpatient center., • Oncology nursing experience in a hospital or clinic setting is a plus – but not required., • Clinical trial experience is a plus but not required., • Strong critical thinking and prioritization skills, with the confidence to be appropriately assertive in advocating for protocol adherence and patient safety., • Excellent communication skills: serve as a key liaison across departments and effectively translate complex clinical information into clear, patient-friendly language., • Proficiency in document and data management tools, including Microsoft Word, Excel, PowerPoint, Adobe, Teams, and SharePoint., • Detail-oriented, assertive, proactive, and adaptable, with the ability to thrive in a fast-paced, academic, and diverse environment. IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis. #LI-DNP Powered by JazzHR HBhyq4TrlT

This Jobot Job is hosted by: Danielle Liguori Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.Salary: $175,000 - $200,000 per year A bit about us: A Series C SaaS startUp seeks Finance & Operations Director to take them to the next level! Why join us? Comp

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