Medical Sciences

Clinical Operations Leader

ArsenalBio’s mission is to develop efficacious and safe cellular therapies for patients with chronic diseases, initially cancer.  Our products are being designed to herald the transition of adoptive cell therapy from a hospital based treatment to outpatient therapy, like most other cancer treatments. 

Our people are our greatest asset, they bring scientific talents in molecular biology, immunology, pharmacology, protein chemistry, computational biology, automation, genome engineering, software and other fields to make the future happen now.

Clinical Operations facilitates excellence in clinical trial execution and partners with Technical Operations to ensure drug product quality and delivery. The Clinical Operations Leader will be responsible for execution of clinical studies and will build and manage clinical study teams. This role will report to the Chief Medical Officer and will work within a matrix team to enable productive interactions across technical operations and clinical functions. This role will require an ability to operate in a fast-paced, highly dynamic environment with partnerships that include both internal and external stakeholders.

What You Will Do:

  • Build and Lead clinical operations strategy to ensure excellence in execution of early phase clinical trials.
  • Partner with Technical Operations, Supply Chain, Translational Science, and all clinical development functions to create an integrated plan for manufacturing drug products, monitoring patients and exploring cell therapy in early phase clinical trials.
  • Advocate for clinical operations team within the scientific leadership team
  • Manage a clinical operations team that is responsible for: Clinical investigator and site management, oversight of GCLP compliant contract services supporting clinical and translational science activities, managing systems to ensure compliance with documented policies, and annual research plans, product project plans, departmental goals, action plans, and budgets
  • Contribute to IND and NDA submissions
  • Represent the company as a senior clinical operations spokesperson before appropriate scientific, medical, regulatory, business and other professional meetings.

  • What You Will Bring:

  • Your whole self.
  • BS or equivalent advanced degree.
  • 15+ years of experience in drug development with recent experience in oncology drug development and cell therapy.
  • 10+ years of experience in managing complex teams.
  • Proven track record of managing complex cell therapy studies, autologous cell therapy experience is a plus.
  • Proven track record of managing complex early phase clinical trials in cell therapy or immuno-oncology.
  • Knowledge of advanced information technology to facilitate complex clinical monitoring.
  • Excellent understanding of regulatory processes and clinical development.
  • Excellent organizational skills and ability to prioritize and deliver results.
  • Excellent communication and influencing skills and proven ability to lead in a matrix environment.
  • Creative and innovative leadership with a sharp objective intellect and experience balancing big picture thinking with detailed analysis.
  • The level of this position will be based on the final candidate’s qualifications.  

  • We are committed to hiring the best talent from diverse backgrounds. A diverse workforce engenders richness of thought, creativity and discovery. We invite individuals who embrace intellectual achievement to bring their unique personal and professional journeys and together we will build transformative cell therapies for cancer patients.

    We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

    To all recruitment agencies: ArsenalBio does not accept agency resumes. Please do not forward resumes to our jobs alias, or Arsenalbio employees. ArsenalBio is not responsible for any fees related to unsolicited resumes.

    Apply     

    ArsenalBio was formed by its investors and scientific founders to discover, develop and commercialize curative and safe cellular therapies for patients with life threatening diseases, initially cancer.

    We believe the most productive and secure route to achieving this goal is to build scaled platforms of technologies challenged with scientific questions to yield informative data from hypothesis driven, well controlled experiments. These data will inform the design of ambitious, best-in-class, lead compositions. Our leads will be rigorously evaluated and honed until we are convinced our matured leads, called development candidates, can be prepared for testing in needy, and vulnerable patients.

    Our products will be designed to speed the transition of cell therapy from hospital-based to outpatient treatments, increasing access to more patients at lower cost to patients, health systems, and insurers.

    To achieve this mission, we are building diverse teams of talented, curious, and caring individuals who believe in our mission and our vision to be sustainable in our business plan, our work habits, and our personal lives.

    Our values create: a foundation for mutual respect, an engaging harmony from many voices, and unselfish behavior to aid our colleagues.

    This is ArsenalBio.
    This is our Company.


    Ken Drazan, MD
    Founding CEO

    Benefits

    Best in Class Health & Wellness Plans

    Flexible Office Hours

    Paid Parental Leave

    Healthy Kitchen Snacks

    Daily Catered Lunches

    Free Onsite Fitness Center

    Unlimited Vacation Days

    Generous compensation and equity packages

    Commuter Benefits

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