The Role
The Clinical Scientist will oversee clinical data monitoring and contribute to regulatory submissions for oncology and hematology programs, collaborating cross-functionally to ensure study execution and quality.
Summary Generated by Built In
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.
What You'll Do:
- 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
What You'll Bring:
- 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
- Experience in oncology, hematology, and/or cell and gene therapy strongly preferred
- 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
- Experience supporting IND submissions and/or global regulatory activities preferred
- Ability and interest to grow into a leadership role as the clinical team expands
The anticipated salary range for candidates for this is below. The final salary offered will depend on several factors, which may include, but is not limited to, relevant years of experience, skills, qualifications, job knowledge, and educational background.
At Kelonia, we’re serious about balance and growth. We offer Flexible Time Off and flexible scheduling aligned with team objectives, a competitive benefits package (health, commuter, and more), and on-site perks including free parking, a state-of-the-art gym, and a food hall, all within a collaborative, inclusive team that invests in your development.
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.
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The Company
What We Do
Kelonia is pioneering a new wave of genetic medicines using its next generation gene delivery platform. The company’s simple and elegant cutting-edge in vivo gene delivery technology uses a few potent lentiviral vector-like particles to precisely and efficiently deliver in vivo genetic cargo to the desired target tissue, and only that tissue, every time. With an initial focus on developing transformational therapies for solid tumors and hematologic cancers, Kelonia is building a pipeline of genetic medicines for a wide range of diseases, with the bold goal of bringing genetic medicines to every patient in need.
