Medical investigator jobs in Irvington, New JerseyCreate job alerts

The (Senior/Executive) Medical Director (MD) - will provide strategic leadership to develop Clinical Development Plan (CDP), working closely with partners in Pre-Clinical, Regulatory, Safety, Stats, & Project Management. Core responsibilities will encompass developing & implementing the Clinical Development Plan and providing leadership to new product development from IND to submission. In addition, the position will ensure program consistency & alignment across studies, working closely with cross functional teams for achieving project goals, within timelines & with high quality. Candidate must possess passion for science and patients, as well as entrepreneurial drive along with strong hands-on experience to help the organization succeed. MAJOR RESPONSIBILITIES AND DUTIES • Provide clinical leadership and strategic medical input for all clinical deliverables in the assigned project or section of a clinical program, • Design Comprehensive Development Plans (CDPs), clinical trials and protocols and execute in accordance with applicable Good Clinical Practice (GCP) regulations., • Lead high quality planning and execution of external meetings and internal stakeholder meetings (e.g., IMs, Governance, DMCs, SSC, Regulatory Authority meetings, etc.), • Define project timelines & deliverable, working closely with cross functional team and assure that deliverable is completed on time, on budget and according to the highest quality, ethical and professional standards., • Identify project risks with input from the cross functional teams, and support resolving issues., • Provide therapeutic area medical and scientific expertise to study teams and key stakeholders., • Anticipate trends in medicine and industry that may/will have an impact on the clinical/commercial viability of products and factors into planning., • Engage and inspire the project/clinical development team through communicating the strategic vision and the operational plan to achieve the vision., • Lead & author relevant sections of INDs, Investigator Brochures, Protocols, CTAs, BLA, ISS, ISEs and clinical expert reports with high quality., • Interact with Regulatory authorities (FDA, EMA etc.) at type C, B, pre-BLA/MAA meetings, Advisory Committee meetings, or other scientific advice forums., • Performs all duties in keeping with the company’s core values, policies and all applicable regulations., • Ensure data review quality (e.g. patient eligibility, Protocol Deviation review, efficacy and safety review) and data accuracy., • Conduct safety review and safety follow up., • Interpret data and ensure CSR quality/Briefing book quality., • Interact with the HA and IRB/EC and Answers to medical questions raised by EC/IRBs and sites; identify the need of protocol amendment and maintain appropriate compliance with protocols., • Interact with the participant Principle Investigators on protocols., • Conduct literature research and competitive intelligence tracking for assigned projects. QUALIFICATIONS • MD or equivalent medical degree is required in addition to advanced knowledge and clinical training in medical/scientific area;, • 5 or more years of pharmaceutical experience in Clinical Development for (Senior) Medical Director., • Experience in an academic clinical research or industry environment spanning clinical activities in Phases I through IV required., • Knowledge of Oncology is required, with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) and proven ability to understand and interpret basic and clinical scientific research reports, • Knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes, • Excellent leadership & organizational skills, analytical skills, presentation skills, and strong experience in translating important data into clinical strategies., • Experience in biotech is preferred., • Willingness to “roll up the sleeves” to contribute to team efforts in a dynamic, fast-paced environment., • Demonstrated ability to build effective working relationships, influence, negotiate, and drive organizational engagement., • Ability to be flexible and adapt quickly to the changing needs of the organization., • Superior interpersonal skills, & communication skills ensuring full alignment of cross functional teams., • Highly collaborative & effective influencing skills and the ability to operate across multiple geographies.

Job DescriptionCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description With supervision, oversees the direction, planning, execution and interpretation of clinical trials or research activities of a clinical development program. Participates in cross-functional teams to generate, deliver, and interpret high-quality clinical data supporting overall product scientific and business strategy. Responsibilities: • With appropriate supervision, manages the design and implementation of study protocols for a clinical development program in support of the overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel, and AbbVie study staff., • Has responsibility for oversight of clinical studies, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned., • Contributes to design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents., • May serve on a Clinical Strategy Team as the clinical representative for the protocols for which the incumbent has responsibility. Contributes to the development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan in collaboration with matrix team members., • Participates in opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies., • Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area., • Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. May be asked to contribute to regulatory responses and discussions., • Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research. Qualifications • Medical Doctor (M.D), Doctor of Osteopathy (D.O.), or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable., • Ability to run a clinical research study with appropriate supervision., • Strong desire to collaborate in a cross-functional setting., • Clinical trial experience in the pharmaceutical industry, academia, or equivalent is preferred., • Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in the design of study protocols is desirable., • Ability to interact externally and internally to support global scientific and business strategy., • Must possess excellent oral and written English communication skills. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: * The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. * We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. * This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

Job Description Location: Remote Website: Lotus Clinical Research | Global CRO for CNS, Pain, Obesity & Metabolic Trials with Integrated Site Network About this role: Primary responsibilities include medical and safety oversight of clinical trials. The Contract Medical Monitor, Psychiatrist provides services to clinical trials with the aim to monitor the safety and wellbeing of study participants, integrity of the project data in accordance with the clinical trial protocol/clinical study protocol (or equivalent documents), standard operating procedures (SOPs), good clinical practice (GCP), and all other applicable directives and regulatory requirements. This role will be approximately 20 hours per week with potential to increase after Q1 2026. This project can go up to 3 years. Responsibilities: Other duties may be assigned. Employee performs all, part, and/or any combination of the duties listed below. • Perform in-depth medical assessment of key study information through review of the protocol, Investigator Brochure, Informed Consent Form, and appropriate literature, • Provide medical input for protocol design, as appropriate, • Participate in Site Initiation Visits and/or Investigator Meetings, • Provide 24/7 medical consultancy support to investigators and study team, • Prepare and/or review the Medical Monitoring Plan, as well as the Safety Management Plan and related study documents, • Support for the clinical team for subject selection regarding interpretation and application of the protocol inclusion and exclusion criteria, • Follow study status via email, phone calls, and participation in team meetings, • Participate in safety review meetings per protocol, • Perform review of Serious Adverse Events (SAE) reported by sites to assess medical contents and case completeness, event seriousness, expectedness, causality and identify potential safety signals at single case level. Collaborate with site staff, Lotus team members and sponsor staff to finalize each event., • Develop and/or SAE narratives and MedWatch reports, • Review protocol deviations and classify according to agreed criteria, • Provide support for the clinical team regarding early discontinuation of treatment and end of study (EOS) assessments, • Provide review of adverse events, concomitant medications and medical history to assess overall risks to subject safety in addition to coding of these data according to relevant dictionaries (MedRA/WhoDrug), • Provide Medical review of other study data such as laboratory results, ECGs, etc. per the scope of work To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. • Must have a medical degree-Psychiatrist (MD, DO or international equivalent). Current, active medical license is preferred but not required., • Prior clinical research experience as a medical monitor, investigator, safety physician or other applicable experience in clinical trial conduct. A minimum of 5 years of relevant experience is required., • Clinical knowledge of the therapeutic patient populations and drug class, • Knowledge and experience working with MedDRA and WHO Drug medical dictionaries., • Broad knowledge of ICH/GCP, • Excellent verbal and written communication skills Excellent organizational and advanced reasoning skills. Strong written and verbal communication skills. Exceptional attention to detail. Strong interpersonal skills. Strong computer skills, including ability to effectively utilize common Microsoft Office products such as Outlook, MS Word and Excel.

Job Description ABOUT VITALIEF Vitalief partners with Sites, Sponsors, and CROs to streamline research operations, reduce costs, and accelerate breakthroughs that improve patient care. We bring deep clinical research expertise together with practical, results-driven consulting to help organizations operate more efficiently and achieve sustainable growth. THE ROLE We are seeking a highly motivated and detail-oriented Master’s graduate to join our client’s dynamic neuroscience research laboratory as a Graduate Research Assistant. The successful candidate will contribute to a growing body of work focused on addiction, brain function, and behavioral neuroscience, playing a central role in manuscript development, grant preparation, data analysis, and general research operations. This position offers an exceptional opportunity for a student with a passion for translational research to gain hands-on experience in the scientific, analytical, and administrative aspects of academic research. COMPENSATION & WORK ENVIRONMENT • Location: Onsite role in a collaborative and supportive research environment in Newark, NJ., • Work Hours: Part-time, 20 to 30 hours/week (Flexible scheduling to accommodate academic commitments), • Duration: 12-month contract, • Manuscript Development: Draft, edit, and prepare scientific manuscripts for publication in peer-reviewed journals, including literature reviews, data interpretation, and figure preparation., • Grant Support: Assist in developing and editing grant proposals, supporting background research, and preparing preliminary data and figures., • Data Analysis: Perform data cleaning, statistical analyses, and data visualization using appropriate software tools (e.g., SPSS, R, Python, MATLAB, or GraphPad Prism)., • Research Coordination: Support day-to-day lab activities, including documentation, database management, and coordination of research timelines., • Literature Review: Conduct and synthesize current literature relevant to addiction and neuroscience to support ongoing studies and future grant submissions., • Master’s degree in Neuroscience, Psychology, Biomedical Sciences, or a related field., • Prior research experience in neuroscience, addiction science, behavioral research, or related disciplines., • Experience with academic/scientific writing and publication processes., • Familiarity with grant writing (NIH or foundation-level preferred) is a strong plus., • Background in statistical or computational data analysis methods, including experience with SAS or SPSS, and some experience with AI models development., • Excellent written and verbal communication skills; collaborative and comfortable working in a team-oriented lab environment., • Self-directed and intellectually curious, professional, reliable, and responsive to feedback., • Strong analytical and critical thinking abilities; high attention to detail and ability to manage multiple priorities., • Proficiency in relevant software for data analysis, literature management (e.g., EndNote, Zotero), and document preparation. PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 20lbs. 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 GiCn07JkZC

Job Description ABOUT VITALIEF Vitalief partners with Sites, Sponsors, and CROs to streamline research operations, reduce costs, and accelerate breakthroughs that improve patient care. We bring deep clinical research expertise together with practical, results-driven consulting to help organizations operate more efficiently and achieve sustainable growth. THE ROLE We are seeking a highly motivated and detail-oriented Master’s graduate to join our client’s dynamic neuroscience research laboratory as a Graduate Research Assistant. Employed as a full-time, fully benefited Vitalief team member, the successful candidate will support research on addiction, brain function, and behavioral neuroscience through manuscript development, grant preparation, data analysis, and general research operations. This position offers an exceptional opportunity for a student with a passion for translational research to gain hands-on experience in the scientific, analytical, and administrative aspects of academic research. WHY VITALIEF? • Contribute: to advancing scientific discoveries that improve patient lives., • PEOPLE FIRST culture: with opportunities for growth and innovation., • 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., • Market-competitive salary: commensurate with experience and academic standing., • Manuscript Development: Draft, edit, and prepare scientific manuscripts for publication in peer-reviewed journals, including literature reviews, data interpretation, and figure preparation., • Grant Support: Assist in developing and editing grant proposals, supporting background research, and preparing preliminary data and figures., • Data Analysis: Perform data cleaning, statistical analyses, and data visualization using appropriate software tools (e.g., SPSS, R, Python, MATLAB, or GraphPad Prism)., • Research Coordination: Support day-to-day lab activities, including documentation, database management, and coordination of research timelines., • Literature Review: Conduct and synthesize current literature relevant to addiction and neuroscience to support ongoing studies and future grant submissions., • Master’s degree in Neuroscience, Psychology, Biomedical Sciences, or a related field., • Prior research experience in neuroscience, addiction science, behavioral research, or related disciplines., • Experience with academic/scientific writing and publication processes., • Familiarity with grant writing (NIH or foundation-level preferred) is a strong plus., • Background in statistical or computational data analysis methods, including experience with SAS or SPSS, and some experience with AI models development., • Excellent written and verbal communication skills; collaborative and comfortable working in a team-oriented lab environment., • Self-directed and intellectually curious, professional, reliable, and responsive to feedback., • Strong analytical and critical thinking abilities; high attention to detail and ability to manage multiple priorities., • Proficiency in relevant software for data analysis, literature management (e.g., EndNote, Zotero), and document preparation. PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 20lbs. 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 Lpz8bcrXgW

Job Description ABOUT US: Ethos Risk Services is a leading insurance claims investigation and medical management company, specializing in surveillance and fraud detection. At the forefront, we provide accurate data and actionable insights that translate into better decision-making for our clients. JOB SUMMARY: Our dynamic Ethos team is seeking an Experienced Field Investigator to conduct surveillance and investigative activities to identify potential fraudulent insurance claims. This role involves performing both stationary and mobile surveillance, obtaining video and photographic evidence, and preparing thorough, detailed reports for clients. KEY RESPONSIBILITIES: • Case Preparation: Prepare for surveillance assignment by reviewing Ethos' preliminary reports and case information., • Field Surveillance: Perform covert surveillance from your vehicle by tracking and capturing high-quality video evidence of surveillance targets., • Report Writing: Draft detailed and court-ready investigative reports summarizing activity and key findings., • Documentation: Finalize case file by submitting case reports and uploading video footage via personal laptop at the end of the day., • Communication: Work closely with the field supervisor and operations teams, receiving regular guidance and mentorship. REQUIREMENTS: • Previous Experience: Demonstrated proficiency in covert surveillance techniques, capturing high-quality video footage, and preparing thorough, well-organized investigative reports., • Driver's License: Valid driver's license and proof of automobile insurance., • Personal Vehicle: A well-maintained vehicle that is always reliable (preferably with tinted windows)., • Surveillance Equipment: A handheld camcorder with high-quality zoom and a covert camera device. Use of stabilization equipment (gimbals, tripods, etc.) is strongly encouraged., • Technology: A reliable laptop, cell phone, and internet service are needed for communication and administrative tasks., • Private Investigator License: Active Private Investigator license or willingness to obtain one (where required by state). WORKING CONDITIONS: • While we aim to keep assignments within a 2-hour drive of your residence, occasional further travel and overnight stays (covered by the company) may be required, • Most surveillance cases start at 6:00AM. End time can vary depending on activity and a typical workday can vary from 3-12 hours., • Weekends/holidays are common workdays as claimants are more likely to be active., • This is an independent role often requiring long hours alone in your vehicle, regardless of weather conditions., • Must remain alert with no external distractions, ready to use videography equipment to document subjects. Ethos Risk Services is an equal opportunity employer that does not discriminate on the basis of religious creed, sex, national origin, race, veteran status, disability, age, marital status, color or sexual orientation or any other characteristic. A background check will be conducted, in accordance to the local state law and regulations. Job Posted by ApplicantPro