Director, Clinical Scientist

About the role

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.

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

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
• 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

Qualifications

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

Skills

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

Benefits

Flexible Time Off and flexible scheduling aligned with team objectives

A competitive benefits package (health, commuter, and more)

On-site perks including free parking, a state-of-the-art gym, and a food hall

Pay

The anticipated salary range for candidates for this role 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.

Schedule

Flexible Time Off and flexible scheduling aligned with team objectives