Join us in developing transformational products for patients in the fight against cancer and immune mediated diseases.

NexImmune is an early stage biotech company developing unique products that harness the power of the natural immune system to treat cancer and other life-threatening diseases. We are seeking highly skilled and motivated individuals to join an entrepreneurial team of experienced professionals dedicated to science, patients and addressing diseases with significant unmet need.  We are uncompromising in our commitment to shared values, a strong work ethic, respect for individuals, and a healthy work/life balance.  The Company focuses on setting clear expectations, empowering people to succeed, and rewarding results.

Benefits include competitive salaries, a 401k retirement plan, health and dental plans, paid vacation (in addition to paid holidays), and opportunities to participate in equity ownership.

NexImmune is an equal opportunity employer and employment decisions are made without regard to sex, race, age, disability, religion, national origin, color or any other protected class.

NexImmune fun in the lab
NexImmune Team
NexImmune serious in the lab
NexImmune working in the lab
  • Vice President - Medical Director

    NexImmune Inc.
    Gaithersburg, Maryland
    www.neximmune.com

    Department: Clinical

    Reports To: President/COO

    Status: Full Time/Exempt

    Position Summary:

    Reporting initially to the President & Chief Operating Officer, the VP, Medical Director will help to advance NexImmune's AIM technology platform, and will be responsible for the strategy, design, and implementation of all clinical development programs targeting Hematologic malignancies. In light of the Company's business model, the ideal candidate will be an exemplary team player, highly skilled in establishing effective working relationships across a broad diversity of internal and external stakeholders, and capable of building and leading high performing teams. As a key member of the Senior Leadership Team, the VP, Medical Director will be the liaison between the company's pre-clinical discovery and translational activities and its clinical programs. The qualified candidate will have a solid combination of scientific / technical expertise and successful product development experience based on a verifiable track record in both early and late stage clinical development. A background in Oncology and/or Hematology is required. Experience with Hematopoietic Stem Cell Transplantation (HSCT) is also desirable, but not required. As early clinical development will be critical, the ideal candidate will also possess a strong translational research background. In addition, the candidate should have proven experience in managing communications with regulatory authorities, clinical research organizations (CROs), clinical investigative sites and Data Safety Monitoring Boards (DSMBs). NexImmune's strategy is to build a small but scalable internal team which will conduct early clinical trials in coordination with CRO's.

    Essential Duties and Responsibilities:

    • Direct and oversee the design and implementation of all clinical projects focused on Hematologic Malignancies.
    • Ensure the quality and validity of scientific and medical content relating to all clinical programs.
    • In partnership with the Company's Leadership Team, develop strategies and implementation plans that achieve the Company's overall goals. Oversee implementation of all such plans to successful execution.
    • Function as a collaborative member of the company's Leadership Team
    • Design scientifically rigorous and cost-effective clinical development programs for the desired indication(s). Present and defend protocols.
    • Establish and manage clinical departmental functions, systems, documentation, and procedures for the successful conduct and audit of clinical studies.
    • Monitor study implementation and execution, leading the analyses and data evaluation process for progress reporting and presentations to Executive Management and Board of Directors, when appropriate.
    • Prepare or assist in the preparation of various official and regulatory documents, for FDA and other regulatory agencies, such as Dossiers, NDAs, INDs, Safety and Annual reports, and handling of responses to official questions about complex safety or efficacy issues.
    • Initiate and oversee the safety reporting system for accountable company products to ensure that Serious Adverse Events are properly reported.
    • Responsible for the safety monitoring of clinical trials.
    • Communicate with FDA and other regulatory agencies to ensure compliance at all times.
    • Work with biostatisticians, key opinion leaders/experts, clinical trial investigators and regulatory personnel to implement protocols/studies and regulatory submissions.
    • Attend public speaking engagements, including but not limited to:
      • Presentation of data at regional and national advisory boards;
      • Conducting site visits and hospital lectures;
      • Presentation of company and data at financial forums;
      • Regular interactions with key medical opinion leaders

    Responsibility:

    • Supervisory: Director, Clinical Operations; Clinical Lead AIM ACT
    • Travel: Up to 50% domestic travel as needed.

    Education and Experience:

    • MD required. Medical specialty and sub-specialty training in Oncology/Hematology. Experience with HSCT is highly desirable, but not required.
    • Five or more years of industry related experience sufficient to demonstrate knowledge of all phases of drug development, registration and approval, from pre-IND to BLA submission.
    • Successful track record in selecting/designing appropriate diagnostic and analytical tools to collect meaningful data, interpreting that data and making decisions which ultimately lead to regulatory approval.
    • Must have in-depth understanding and experience in leading and managing clinical teams and Clinical Research Organizations in the conduct of clinical trials to support the filing of INDs (Investigational New Drug), and BLAs (Biologic License Applications).
    • Experience in the field of immuno-therapy is strongly preferred
    • Solid knowledge/experience in Translational Research & Early Clinical Development
    • Demonstrated public speaking experience.

    Desired Key Competencies:

    • Excellent writing, communication, interpersonal and negotiation skills
    • Ability to forge positive interpersonal relationships with a particular emphasis on senior management, Board of Directors, external organizations, regulatory agencies and key opinion leaders.
    • Effective prioritization skills and ability to delegate tasks to others while maintaining responsibility for performance and outcome
    • Highly collaborative and strong team player
    • Strong leadership capabilities, a strong work ethic, and the ability to keep pace with the organization's growing and changing needs
    • Excellent analytical and problem-solving skills
    • Entrepreneurial spirit and ability to do more with less
    • Able to function both autonomously as well as in a team
    • Able to make sound judgment calls in a timely manner based upon a mixture of experience, knowledge, analysis and judgment.
    • Able to manage multiple activities and tasks simultaneously; able to use resources effectively and efficiently; able to "shift gears" quickly and comfortably.
    • Able to negotiate in tough situations, balancing candor with diplomacy

    Qualified, interested candidates should send a resume to: admin@neximmune.com

  • Sr. Manager/Director Clinical Operations

    NexImmune Inc.
    Gaithersburg, Maryland
    www.neximmune.com

    Department: Clinical

    Reports To: President/COO

    Status: Full Time/Exempt

    Position Summary:

    Independently manages Phase I/II clinical trials of significant complexity (Allo-HSCT, Cellular Therapies). The role is expected to manage all sites and vendor (e.g. Clinical Research Organization) related issues, with supervision from the AIM ACT Clinical Lead. Direct experience in the areas Hematological malignancies and/or Stem Cell Transplantation strongly preferred.

    Essential Duties and Responsibilities:

    • Manages study operational plan and CRO activities, including project timelines & quality of deliverables, and managing approved trial budget(s) throughout the life of the assigned clinical trial(s)
    • Participates in the selection of study vendors for assigned studies
    • Maintains frequent and meaningful contact with CROs to assess performance and provide guidance as needed
    • Reviews and refines clinical operational plans including the study monitoring plan and other plans as needed
    • Coordinates internal and external clinical development activities of all team members involved in the design and conduct of assigned clinical trials
    • Contributes to relevant study documentation including clinical protocols, statistical analysis plan, clinical study reports as well as operational plans (CMP, DMP)
    • Develop and manage study timelines and may develop and manage program timelines
    • Participates in the selection of investigational sites with input / direction from Clinical Lead
    • Assists with protocol design and medical issue resolution
    • Proactively identifies project risks and resolves with some supervision
    • Participates in study data review and other review activities as assigned
    • Oversees clinical trial sites' adherence to pertinent regulations through review of monitoring reports, CQA-GCP audit report, communications with investigators, study site personnel, CRAs, and other CRO/designee personnel
    • Leads ongoing review of data to ensure GCP
    • Oversees the submission of trial-related and essential documents to the Trial Master File
    • Identifies and provides solutions to clinical trial issues and/or risks
    • Represents Clinical Operations in cross-functional initiatives
    • Provide or facilitate training to clinical study teams on assigned protocol specific topics
    • Work closely with other teams in the organization, e.g. quality, regulatory, manufacturing, etc.
    • Provide input into non-project related activities and development of department processes

    Responsibility:

    • Supervisory: None
    • Travel: Less than 25% domestic travel as needed

    Education and Experience:

    • BS or Master's Degree in nursing, life science, or related field (or equivalent experience)
    • Minimum of 8 years of clinical research experience, at least 3 of which are as a Project Manager for clinical studies at a CRO and/or pharma/biotech organization
    • Previous experience negotiating vendor/site contracts and budget management
    • Thorough understanding of FDA, ICH and GCP guidelines
    • Experience with Early Phase and Registrational clinical trials
    • Proven track record showing clear proficiency in clinical project management skills
    • Proven complex problem-solving skills
    • Solid vendor management skills, e.g. CRO, Laboratory & Clinical supply logistics
    • Broad understanding of clinical operations related to clinical development functions
    • Detailed understanding of all aspects of clinical protocol design and implementation & overall drug development
    • Ability to effectively interface with medical personnel at clinical site(s)
    • Ability to write and edit technical documents, such as protocols, protocol amendments, informed consent, and other trial-related documents
    • Detail and team-oriented with excellent cross-functional team leadership and participation skills
    • Proficiency with computer programs including Microsoft Office suite and Microsoft Project

    Desired Key Competencies:

    • Excellent communication skills. Excellent interpersonal, verbal and written communication skills are essential in this small company and collaborative work environment
    • Self motivated and independently minded
    • Positive interpersonal skills with the ability to interact with individuals from a variety of levels and function
    • Self-organizer, meticulous hands-on habits, keen attention to detail
    • Strong quantitative and analytical skills
    • Responsive, can-do attitude
    • Can coordinate parallel tasks across multiple projects, demonstrating prioritization
    • Ability to quickly adapt to a rapidly changing environment and demands
    • Ability to interpret and effectively execute upon a variety of instructions provided in written, oral, diagram or schedule formats

    Qualified, interested candidates should send a resume to: admin@neximmune.com

  • Sr. Manager/Assoc. Dir/Dir Manufacturing Technical Operations

    NexImmune Inc.
    Gaithersburg, Maryland
    www.neximmune.com

    Department: Manufacturing

    Reports To: Chief Business Officer

    Status: Full Time/Exempt

    Position Summary:

    This position is responsible for developing and maintaining GMP compliant processes and delivering material for clinical and ultimately commercial development. This includes ensuring, through key partners, quality systems, document control and archive, change control, training requirements, reports, and CAPA systems are in place in a stage appropriate manner meeting all regulatory and quality requirements. This position supports the drug product manufacturing process with the following responsibilities.

    Essential Duties and Responsibilities:

    • Ensuring all aspects of the clinical manufacturing process meet cGMP requirements, including clinical grade reagents, materials, processes and facilities.
    • Developing a central tracking system for programs, reporting and quality controls across CMO facilities.
    • Assemble all necessary material to support CMC in the IND submission and develop CMC Sections of the IND package in collaboration with internal and partner experts for review. Additionally, as programs progress, define future process modification needs, timing and documentation for future regulatory submissions (clinical and commercial product)
      • Develop and track detailed manufacturing plan, identify key scenarios.
      • Facilitate all aspects of cGMP protein manufacturing, including stable cell line development MCB development and that all testing (sterility, viral clearance, stability) for source and final proteins are place.
      • Finalize testing and release plans for the aAPC ensuring all assays developed and testing kits used are in place in alignment with FDA feedback. Determine stability needs for adequate storage of both the P1 material and the aAPC for future use.
      • Develop plan and timelines for assay qualification across all components
      • Identify risk and propose mitigation plans for CMC operations
    • Identify and assess additional manufacturing partners for late stage development, commercial scale up and future expansion of the platform across all aspects.
    • Manage partnerships and coordination across CMO’s and track budgets against current and future timelines and plans.

    Education and Experience:

    • B.S. in Life Science or Chemical engineering required
    • 3+ years technical Manufacturing, Process engineering
    • 1+ years in a cGMP manufacturing setting of biologics
    • Full understanding of current Good Manufacturing Practices is required
    • This role requires a working knowledge of Microsoft Office based programs for Manufacturing/Operating procedure writing, technical report generation, product tracking and trending data analysis and Operational Excellence reports.
    • Familiarity with analytical instrumentation and cGMP process equipment is required
    • Superior customer facing skills that instill client confidence.

    Desired Key Competencies:

    • Excellent communication skills.
    • Self motivated and independently minded.
    • Positive interpersonal skills with the ability to interact with individuals from a variety of levels and function.
    • Self-organizer, meticulous hands-on habits, keen attention to detail.
    • Strong quantitative and analytical skills.
    • Responsive, can-do attitude.
    • Can coordinate parallel tasks across multiple projects, demonstrating prioritization.
    • Ability to quickly adapt to a rapidly changing environment and demands.
    • Ability to interpret and effectively execute upon a variety of instructions provided in written, oral, diagram or schedule formats.

    Work Environment:

    Frequent: Speaking; hearing; sitting; use of hands/fingers; handling or feeling objects, tools or controls; close vision; color vision; peripheral vision; ability to adjust focus.

    Occasional: Standing; walking indoors; reaching with hands and arms; stooping; kneeling; crouching; lifting and/or move up to 10 lbs.

    General: Moderate noise level, similar to typical office environment with computers, printers and light traffic.

    Qualified, interested candidates should send a resume to: admin@neximmune.com

  • Sr. Manager/Assoc. Director Regulatory Operations

    NexImmune Inc.
    Gaithersburg, Maryland
    www.neximmune.com

    Department: Regulatory

    Reports To: Chief Business Officer

    Status: Full Time/Exempt

    Position Summary:

    NexImmune is looking for a Sr. Manager or Associate Director of Regulatory Operations and Publishing to join our growing team. This role will be responsible for driving the process of developing and reviewing high quality, compliant IND submissions and additional applications for NexImmune’s Adoptive Cellular Therapy program. This position will require collaboration with all internal stakeholders and external partners to develop specific sections that form the basis of filing documents and to manage the e-submission development and submission process.

    Essential Duties and Responsibilities:

    • Lead development and publication of submission documents such as new applications, amendments, annual reports, etc. in eCTD compliant format and submit to the FDA via the Electronic Submissions Gateway (ESG) or other global regulatory agencies using an equivalent submission portal.
    • Coordinate publishing efforts across multiple key stakeholders.
    • Lead the development and filing of the IND.
    • Filing the Orphan Drug Applications and Priority Review Applications as appropriate.
    • Assist with the generation of XML documents as backbone for electronic submissions.
    • Assist in interpreting FDA and ICH guidance as related to the established eCTD templates and submission types (IND, DMF, Pre-Meeting Packages, Annual Report and BLA etc.)
    • Prepare documents for submission by scanning, rendering, bookmarking, and hyperlinking with supportive documents.
    • Perform quality review of documents for compliance to regulatory guidelines.
    • Maintain and track electronic submissions.
    • Assist with standard operating procedures (SOP) and working instruction (WI) creation, update, and maintenance
    • Perform additional Regulatory Affairs duties as requested.
    • Travel: Less than 20% is needed

    Education and Experience:

    • Bachelor’s degree in scientific discipline.

    Desired Key Competencies:

    • Three to five years of experience in regulatory filing for biologics at a minimum, cell therapy a plus; minimum of 1 year experience in eCTD Publishing and processing.
    • Solid knowledge of drug development, FDA, EMA and IHC guidelines and current Good Manufacturing Practices (cGMP)
    • Previous experience with early development programs through IND submission
    • Excellent organizational and communication skills both written and verbal.
    • Ability to work independently as well as in a team
    • Positive, energetic and proactive with ability to adapt rapidly to changing environment and demands.
    • Proven ability to identify and resolve regulatory issues
    • Self-organizer, meticulous hands-on habits, keen attention to detail.
    • Strong quantitative and analytical skills.
    • Responsive, can-do attitude.
    • Can coordinate parallel tasks across multiple projects, demonstrating prioritization.

    Qualified, interested candidates should send a resume to: admin@neximmune.com