Associate Director, Clinical Development Operations

Kelonia Therapeutics

Kelonia Therapeutics

Operations
Boston, MA, USA
Posted on Friday, May 31, 2024
Here at Kelonia Therapeutics, we aren’t just a preclinical company; we’re trailblazers in viral engineering, pushing the boundaries of in vivo lentiviral gene and cell therapy. We're not just a team; we're dreamers on a mission to bring the promise of cell and gene therapy to every patient in need.
At Kelonia, we've gathered a group of pioneers in cell and gene therapy to lead our journey, with extraordinary scientific founders at the helm, providing the cutting-edge technology that sets us apart. We're not just building a company; we're cultivating a culture—one that values both skill and care.
Are you ready to be a part of our remarkable journey? We're looking for someone exceptional to join our growing team as an Associate Director, Clinical Development Operations. This isn't just a job; it's an opportunity to contribute to groundbreaking therapies, to be part of a company's inception, and to make a transformative impact on patients' lives. If you're passionate about scaling a company from the ground up, making a real difference, and shaping the inclusive culture we're proud of, this opportunity is tailor-made for you. Join us and be a driving force in achieving excellence in viral engineering.

What You'll Do:

  • Lead the day-to-day clinical development operations team for one or more clinical trials.
  • Oversee clinical development operations vendors (e.g. clinical monitoring, data management, central labs, etc.) including operational and financial metrics.
  • Develop and maintain study-related tools and templates for clinical trials.
  • Identify and mitigate risks associated with study operations.
  • Provide regular status reports to department leadership.
  • Oversee study financial forecasting and accruals.
  • Efficiently and effectively manage investigator grant payments for domestic sites.

What You'll Bring:

  • Minimum 10 years of experience in oncology clinical research, preferably as a Sponsor
  • Ability to work independently in a startup environment.
  • Skilled in managing competing priorities effectively.
  • Hands-on leadership with experience with clinical operations vendor oversight.
  • Strong working knowledge of applicable Federal Regulations and ICH GCP are a must; knowledge of foreign clinical trial operations is a plus.
  • Excellent written and verbal communication skills with diverse stakeholders
  • Preferred experience in cell therapy, multiple myeloma, and/or gene therapy is strongly preferred.
Our goal at Kelonia is to promote a healthy work/life balance and we hope the benefits we provide are a direct reflection of that goal. We offer a hybrid workplace that provides employees with flexibility to work in the office or remotely dependent on job responsibilities. *We also offer a team-focused environment with a top-notch benefits package (health, dental, flexible PTO, and commuter) to match. Kelonia fosters a collaborative and inclusive workplace that allows you to become a part of a small team that places equal value on talent development and meeting company goals.
Kelonia Therapeutics is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Kelonia does not accept unsolicited resumes from any source other than directly from candidates.