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
  • Head of Clinical Development

    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 Head of Clinical Development 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 Head of Clinical Development 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: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