Director, Clinical Scientist

Kelonia TherapeuticsBoston, MA
Onsite

About The Position

At Kelonia Therapeutics, our ambitions are bold: to dramatically expand the benefit and reach of genetic medicines. Our goal is to change what’s possible for genetic medicine by building the capabilities, experience, and commitment to bring life-saving medicine to every patient in need. We are a human-first company, driven by a mission to develop transformative genetic medicines for patients and their loved ones. We have brought together pioneers in cell and gene therapy, guided by extraordinary scientific founders and a team committed to turning breakthrough science into real-world impact. As we grow, we are building a culture that values rigor, collaboration, and care for one another. As a Clinical Scientist in the Clinical Development group, you will support day-to-day medical monitoring, clinical development, data services, and pharmacovigilance for lead programs, as well as future indications. 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.

Requirements

  • Advanced degree required: PharmD, PhD, or MS in a health or life sciences field
  • 3–6+ years of experience in clinical development within biotech or pharma, preferably in a Clinical Scientist or similar role
  • Demonstrated experience authoring and contributing to: Clinical protocols and amendments, Investigator’s Brochures, and Regulatory submission documents and clinical datasets
  • Strong understanding of clinical trial design, execution, and data interpretation
  • Ability to independently analyze complex clinical data and communicate insights clearly
  • Comfortable operating in a hands-on, execution-focused role with high ownership of deliverables
  • Strong cross-functional collaboration skills in a fast-paced, matrixed environment
  • Ability and interest to grow into a leadership role as the clinical team expands

Nice To Haves

  • Experience in oncology, hematology, and/or cell and gene therapy strongly preferred
  • Experience supporting IND submissions and/or global regulatory activities preferred

Responsibilities

  • Serve as a core clinical development team member supporting multiple oncology, hematology, and/or cell therapy programs
  • Perform ongoing review and interpretation of clinical data, including safety, efficacy, and longitudinal patient data
  • Act as a primary contributor and owner of key clinical deliverables, including: Clinical study protocols and protocol amendments, Investigator’s Brochures, Clinical study reports and data summaries, and Regulatory submission documents (e.g., INDs, amendments, briefing materials)
  • Collaborate cross-functionally with Clinical Operations, Regulatory, Biometrics, Translational Sciences, and Medical teams to ensure high-quality and timely study execution
  • Support clinical trial conduct and oversight, including data review, issue identification, and resolution
  • Contribute to regulatory interactions and submissions, including preparation of FDA-facing materials and global regulatory documentation
  • Partner with Clinical Operations to support patient enrollment strategy and execution, including upcoming U.S. and Australia expansion
  • Synthesize increasing volumes of clinical and follow-up data to generate actionable insights for program decision-making
  • Support engagement with external investigators, CROs, and key opinion leaders
  • Contribute to the evolution of clinical development processes and infrastructure as the organization scales

Benefits

  • Flexible Time Off
  • flexible scheduling
  • health
  • commuter
  • on-site perks including free parking
  • a state-of-the-art gym
  • a food hall
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