Careers

Available Positions

In our Corporate Headquarters in Northern New Jersey, we foster a challenging and rewarding work environment for our employees. We are committed to attracting, developing and maintaining a diverse team of motivated, talented individuals where each person has the opportunity to realize his or her full potential.

Associate Director, Clinical Pharmacology

We are seeking an Associate Director, Clinical Pharmacology (Pharmacokinetics and Pharmacodynamics) to be the resident expert in pharmacokinetics (PK) and pharmacodynamics (PD). He/she will assist in preparing Clinical presentations to outside parties and work internally to extract information necessary for these presentations.

Primary Responsibilities:

  • Provide pharmacokinetic/pharmacodynamic components for use in study protocol design.
  • Provide expertise and analyze Clinical study results in the areas of clinical PK and PD.
  • Coordinate department efforts in regard to incorporating data and information for presentations for outside parties and ensuring accuracy.
  • Provide input to Clinical Research and Regulatory personnel in preparation of PK/PD reports and in the quality control of tables, listings, and other documents.

Required Qualifications:

  • Doctorate degree (e.g., Ph.D., M.D., M.D./Ph.D., Pharm.D.) in pharmacology, pharmacokinetics, pharmacodynamics, pharmacy, or related scientific field with at least 3 years of relevant Clinical Research experience in industry (strongly preferred) or academia.
  • Demonstrated understanding of the principles, concepts, practices, and standards of clinical pharmacology related to clinical research and development in the biopharmaceutical/ pharmaceutical/ biotechnology industry. Needs to stay current on new developments within the field.
  • Thorough knowledge of drug development and global regulatory (e.g., FDA and ICH) guidelines and requirements.
  • Must be able to learn, develop, and follow task-specific procedures.
  • Excellent communication (verbal and written) skills, including demonstrated ability to effectively write, review, and edit clinical, scientific, and regulatory documents. Must also possess excellent organizational and interpersonal skills.
  • The ability to understand, organize, and guide other functional staff to work concurrently on several projects while being able to work independently.
  • Must be attentive to detail and accuracy of information, flexible, and open to feedback and suggestions.
  • Advanced computer literacy in MS Office (Word, PowerPoint, Excel, and Outlook) applications is essential.

Physical Requirements and Working Conditions:

  • Environment: Standard office setting; exposure to computer screens.
  • Physical: Primary functions require sufficient physical ability to work in an office setting and operate standard office equipment including use of a computer keyboard. Sedentary work, which includes exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently to move objects. Involves sitting most of the time, but may include walking or standing for brief periods of time.
  • Vision: See in the normal visual range with or without correction; vision sufficient to read computer screens and printed documents.
  • Hearing: Hear in the normal audio range with or without correction.

Salary will be commensurate with experience, plus a comprehensive benefit program.

Local candidates preferred. No relocation assistance is available for this opportunity.

United States work visa sponsorship is not available for this position. Please note that Immunomedics, Inc. is not an E-Verify employer and cannot assist EAD holders in extending their OPT authorization. At the time of application, please indicate if you have legal authorization to work for Immunomedics, Inc. in this role.

Please apply only if you meet all of the required qualifications listed above and provide salary history and/or expectations at the time of application. Resumes without salary information will not be considered.

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Senior Director, AVP, or Vice President, QA

We are seeking a Senior Director, AVP, or Vice President, Quality Assurance to be responsible for the Site Quality Project Management, Quality Assurance, Compliance and Validation functions for biopharmaceutical products. This position directs implementation per the Company’s Strategic Plan, supports Business Development objectives, establishes and maintains Quality Systems to ensure compliance to regulations governing drug development and clinical studies, and directs Quality Systems for the Corporate site and Quality Assurance activities related to the manufacture, testing, and release of raw materials and clinical products.

Primary Responsibilities:

  • Main focus will be ensuring we are FDA/EU “inspection ready” as it relates to our Phase III pancreatic cancer trial.
  • Conducts Project Management activities for Product Technical Transfers and Pipeline Advancement.
  • Contributes to strategic planning and development to ensure compliance and process optimization.
  • Chairs the Quality Council.
  • Represents the Company as compliance/quality liaison for regulatory authorities, corporate partners and other entities as required.
  • Establishes business continuity plans.
  • Develops departmental budgets; identifies cost savings opportunities.
  • Reviews technological solutions.
  • Provides development and succession plans for departmental employees.
  • Establishes Quality Agreements with business partners.
  • Supervises the Site Project Management, Quality Assurance, Compliance and Validation functions and personnel.
  • Directs the following systems for the Corporate site:
    • Investigations and CAPA
    • Stability Program
    • Material Release, Shipment, and Inventory Management functions
    • Process, Equipment, and Cleaning Validation
    • Change Control
    • Coordination of Regulatory Inspections and audits. Direct and conduct internal and external audits
    • Supplier/ Vendor/ Contract Laboratory Qualification Program
    • Regulated Documents and Records
    • GxP Training
  • As applicable and appropriate, manages Business Partner transitions.

Required Qualifications:

  • Bachelor's degree in engineering, science, or equivalent required; advanced degree preferred.
  • At least 10 years of Quality Management/Compliance experience in the biotechnology or pharmaceutical industry strongly preferred.
  • Experience in multiple phases of Clinical Research and preferably Commercial Supply Chain.
  • Demonstrated leadership of and team participation in technical transfers and product phase-forward and scale-up (Research and Development to Clinical to Commercial) required; leadership experience strongly preferred.
  • Experience writing change controls, investigations/ CAPA, SOPs, protocols, reports and validation documents is mandatory; Validation, GAMP, Part 11-compliant systems is a plus.
  • Experience directly managing Regulatory Authority inspections highly desirable.
  • Must have knowledge of domestic and international regulations concerning GxP and Quality Systems, particularly concerning biologics, aseptic processing, and cleanroom environments.
  • Strong agent of change with the ability to translate strategic plan and vision into specific deliverables for timely implementation.
  • Excellent managerial, interpersonal, and written and verbal communication skills required in addition to strong scientific writing and responsible business communication abilities.
  • High proficiency with computer applications.

Required Qualifications:

  • Directly supervises Quality Assurance and Compliance and Validation and Technical Services personnel for maximum effectiveness, cross-training, and succession planning.
  • Carries out direct supervisory responsibilities in accordance with the department-set goals. Responsibilities include interviewing and onboarding; employee training and development; planning, assigning, and directing work; appraising performance; rewarding and disciplining; corrective action and complaint resolution.

Salary will be commensurate with experience and includes a comprehensive benefit program.

United States work visa sponsorship is not available for this position. Please note that Immunomedics, Inc. is not an E-Verify employer and cannot assist EAD holders in extending their OPT authorization. At the time of initial application, please indicate if you have legal authorization to work for Immunomedics, Inc. in this role.

Please apply only if you meet all of the required qualifications listed above and provide salary history and/or expectations at the time of application.

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QA Associate, Raw Material Release and Clinical Shipments

We are seeking a Quality Assurance Associate to be responsible for all QA related aspects of material handling, storage, shipping and control, and all associated documentation. This position may also be cross-trained on Product Disposition and Regulated Document/Training functions.

Primary Responsibilities:

  • Quarantine materials, inspect shipments, examine Certificates of Analysis, review test results, and determine release status.
  • Coordination of clinical shipments.
  • Preparation and circulation of controlled documents (e.g., specifications, labels).
  • Inventory management.
  • Stability Data Review.
  • Generation of associated reports.
  • Conduct changeovers in production area as required.
  • Participate in audits, investigations, SOP preparation/review, and other projects as appropriate.

Qualifications:

  • Bachelor’s degree in science or equivalent is required; Biology/Chemistry preferred.
  • 1 year of prior work experience in a Biotechnological, Pharmaceutical, or Clinical environment and GxP training required.
  • Experience in Raw Material Release or Product Disposition functions strongly preferred.
  • Excellent written and verbal communication skills required, including Responsible Business Communication; scientific writing experience is preferred.
  • Superior attention to detail, organizational skills, and the ability to handle multiple tasks in a timeline-driven environment necessary.
  • Must be proficient with MS Office applications.
  • Ideal candidate will possess a strong customer service philosophy.

Starting salary up to 45k, commensurate with experience, plus a comprehensive benefit package.

United States work visa sponsorship is not available for this position. Please note that Immunomedics, Inc. is not an E-Verify employer and cannot assist EAD holders in extending their OPT authorization. At the time of application, please indicate if you have legal authorization to work for Immunomedics, Inc. in this role.

Please apply only if you meet all of the required qualifications listed above and provide salary history and/or expectations at the time of application.

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Administrative Assistant, Clinical/Regulatory

We are seeking a capable and professional individual to provide comprehensive administrative support to members of the Clinical Research/Data Management and Regulatory Affairs departments.

Primary Responsibilities:

  • Timely processing of original and amended clinical trial documents such as protocols, investigator brochures, informed consent documents, and clinical study reports.
    • Prepare documents in MS Word by proofreading, formatting, paginating, revising, and generating final copies that incorporate multiple edits from several reviewers.
    • Distribute finalized documents internally to IMMU personnel and externally to clinical trial sites. Keep active site contact lists up-to-date.
    • Establish/maintain an incoming/outgoing document tracking system.
    • File documents as part of the Trial Master File.
  • Process/track clinical payments to participating study sites and provide notification of check issuance to appropriate IMMU personnel.
  • Coordinate travel arrangements, including airfare, hotel, and rental car reservations.
  • Prepare and process expense reports, purchase orders, and check requests.
  • Perform other administrative/clerical activities as necessary.
  • Provide Front Desk back-up/break support as part of rotational schedule.

Qualifications:

  • Must possess advanced MS Word proficiency with the ability to proofread, format, and edit large, multi-paginated reports. Must be adept at inserting/adjusting headers, footers, tables/charts, margins, table of contents, and bibliographies. Must be proficient with tracked changes and possess the ability to use several marked-up versions of a document to create one master copy that includes all necessary revisions.
  • Must possess intermediate MS Outlook and Excel proficiency. Basic familiarity with PowerPoint and/or Access is a plus.
  • 2-5 years of related work experience in relevant industry (pharmaceutical, biotechnology, clinical research, or healthcare) required.
  • Knowledge of medical terminology preferred.
  • Proven ability to succeed in a fast-paced, deadline-driven environment, with the availability to work overtime hours when needed.
  • Accuracy and strong attention to detail are critical competencies.
  • Must be well organized, able to assess priorities while actively seeking input as necessary, and have strong follow-through and problem solving skills.
  • Must have strong communication, interpersonal, and business relationship skills, and be able to maintain a high degree of professionalism and confidentiality.
  • Successful performance if this position requires flexibility, proficiency in multi-tasking, and the ability to work both independently and as a team member.
  • High school diploma required. Associate’s or Bachelor’s degree in life science, business, computers, or office management preferred.

Starting salary up to 55k, commensurate with experience, plus a comprehensive benefit package.

United States work visa sponsorship is not available for this position. We can only consider your candidacy if you have authorization to work in the United States for any employer. At the initial time of application, please indicate your work authorization status. Please also note that Immunomedics, Inc. is not an E-Verify employer and cannot assist EAD holders in extending their OPT authorization.

Local candidates preferred. No relocation assistance is available for this opportunity.

Please apply only if you meet all of the required qualifications listed above and provide salary history and/or expectations at the time of application.

Resumes without salary information will not be considered.

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Clinical Trial Associate

This position is in our Clinical Research/Data Management department.

We are seeking a Clinical Trial Associate to be responsible for tracking and coordinating all of the clinical trial master files for patient data through the regulatory process, the clinical trial, and final submission.

Primary Responsibilities:

    Acts as key support person for receiving, tracking and filing all clinical trial master file regulatory documents for all Immunomedics-sponsored studies (documentation, insurance, contracts, etc.)

  • Maintains/generates reports from clinical research tracking database.
    • Patient accrual
    • Trial Master File/regulatory documentation by site
    • Site closures
    • Site numbers
    • Investigator reports by protocol
    • Product shipments/returns
    • Study materials shipped (study binders, initiation packages, etc.)
  • Clinical Trial Study Documentation
    • Compile proper documentation prior to trial initiation
    • Create in-house study documentation binders/files
    • Track all study documentation for all clinical trials (date-stamp, enter to database, file)
    • Liaise with Regulatory Affairs to transmit proper documentation for filing to FDA and other European agencies
    • Create U.S./European on-site study trial master file binders
  • Case Report Forms (CRFs) Tracking and Maintenance
    • Create in-house patient binders/files
    • Create CRF binders (labels, cover sheets, etc.)
    • Track CRF pages for all clinical trials
    • Date stamp all incoming CRF pages for all clinical trials
    • Redact CRF source documents and add patient numbers for anonymity
  • Clinical Trial Insurance
    • Obtain site specific policies or local coverage as needed
    • Liaise with insurance company to obtain study insurance
    • Provide necessary forms, protocols, patient informed consents
    • Provide necessary translations in the country’s native language
  • Creates site initiation packages for all new sites and ships study materials as needed.
  • Handles clinical drug shipments in the absence of the Administrative Associate, Clinical/Marketing.
  • Qualifications:

    • High school diploma required, with 3-5 years of related experience with basic understanding of the clinical trial master file/development process; or equivalent combination of education and experience. Associate’s Bachelor’s degree in science, business, computers, or office management preferred. Prior work experience in a research setting or healthcare position also preferred.
    • Accuracy and attention to details critical with ability to proofread work.
    • Ability to work and with others and be able to multi-task.
    • Organized, able to assess priorities, and meet deadlines.
    • Competent in MS Excel, Word, and PowerPoint.
    • Strong interpersonal-communication and business-relationship skills.
    • Detail oriented with strong organizational and follow through skills.
    • A high degree of professionalism.
    • Knowledge of medical terminology preferred.

    Physical Requirements and Working Conditions:

    • Environment: Standard office setting; exposure to computer screens.
    • Physical: Primary functions require sufficient physical ability to work in an office setting and operate standard office equipment including use of a computer keyboard. Sedentary work, which includes exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently to move objects. Involves sitting most of the time, but may include walking or standing for brief periods of time.
    • Vision: See in the normal visual range with or without correction; vision sufficient to read computer screens and printed documents.
    • Hearing: Hear in the normal audio range with or without correction.

    Annual salary of 40k-50k, commensurate with experience, plus a comprehensive benefit program.

    Local candidates preferred. No relocation assistance is available for this opportunity.

    United States work visa sponsorship is not available for this position. Please note that Immunomedics, Inc. is not an E-Verify employer and cannot assist EAD holders in extending their OPT authorization. At the time of application, please indicate if you have legal authorization to work for Immunomedics, Inc. in this role.

    Please apply only if you meet all of the required qualifications listed above and provide salary history and/or expectations at the time of application. Resumes without salary information will not be considered.

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    Scientist, Pre-Clinical Research

    This position is in our Pre-Clinical department.

    We are seeking a Scientist to develop state-of-the art assays as well as apply established assays to support our ongoing clinical programs of antibody-drug conjugates and naked antibodies.

    Primary Responsibilities:

    • Maintain cell cultures used in experiments.
    • Develop new assays suitable for Quality Control to validate.
    • Perform established assays for in vitro characterization of monoclonal antibodies, which include FACS, ADCC, CDC, MTS, Western blots, FISH, ELISA, etc., as instructed. Document such studies following cGLP guidelines.
    • Record research work in Company supplied notebooks. Periodically has the notebook reviewed and signed.
    • Provide weekly research updates to supervisor and attend department meetings.

    Qualifications:

    • Bachelor’s degree in biology, immunology, or a related discipline with 5 years of relevant experience and/or training; or
      • 3 years of relevant working experience with a Master’s or higher degree.
    • Must have solid aseptic techniques, be well versed in ELISA, flow cytometry, western blots, and FISH techniques.
    • Must be a computer-literate individual with proficiency in MS Office products (e.g., Word, Excel, Outlook).
    • Must be well organized, have excellent analytical, verbal and written communication, and interpersonal skills, and recognize the value and spirit of teamwork.
    • Demonstrated ability to work independently and efficiently, meet demanding deadlines, and balance multiple tasks in a fast-paced, continually changing environment.

    Annual salary up to 70K, commensurate with experience, plus a comprehensive benefit program.

    United States work visa sponsorship is not available for this position. Please note that Immunomedics, Inc. is not an E-Verify employer and cannot assist EAD holders in extending their OPT authorization. At the initial time of application, please indicate if you have legal authorization to work for Immunomedics, Inc. in this role.

    Please apply only if you meet all of the required qualifications listed above and provide salary history and/or expectations at the time of application. Resumes without salary information will not be considered.

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    Please check back for future job postings.

    Statement to Agencies and Recruiters

    Immunomedics typically recruits candidates directly rather than with the assistance of a third party agency or recruiter. We will only pay a fee for candidates submitted for consideration by any method under the following conditions: 1) There is a current, signed agreement or contract in existence between Immunomedics and the agency/recruiter prior to the submission AND 2) The candidate was submitted directly for a specific, agreed‐upon search. If a candidate is submitted to Immunomedics without meeting the aforementioned conditions, we explicitly reserve the right to pursue and hire the candidate without any financial obligation to the agency or recruiter. All vendors, approved or not, must not contact or solicit our employees regarding recruiting.

    At this time, we are not actively looking to engage with any new agencies or recruiters. If you still wish to send information for us to review, please forward the relevant documentation to hr@immunomedics.com OR mail documentation to Immunomedics, Inc., Attention HR Department, 300 American Road, Morris Plains, NJ 07950.


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    Available Positions at Immunomedics