Sr. Medical Director/VP, Clinical Development

Kelonia Therapeutics • Boston, MA

16d • Hybrid

About The Position

Here at Kelonia Therapeutics, we aren’t just a clinical 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. 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 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 a Sr. Medical Director/VP in the Clinical Development group to provide medical and strategic leadership from IND through clinical proof-of-concept and beyond. In this role, you will guide and support clinical programs, oversee the 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, be at the forefront of advancing our oncology programs, and to make a transformative impact on patients' lives. Join us at the forefront of innovation and help write the next chapter in gene therapy.

Requirements

• MD required with expertise in oncology, hematology, or a related field.
• 3+ years of experience in oncology drug development, including early-stage clinical trials in biotech or pharma.
• Required experience CAR-T, advanced oncology modalities such as immunotherapies, or gene therapy.
• Strong understanding of tumor biology, immuno-oncology, and targeted therapies.
• Expertise in translational research and regulatory requirements for advancing compounds from preclinical to clinical development.
• Ability to analyze complex scientific data and communicate findings effectively to both technical and non-technical stakeholders.
• Strong leadership, collaboration, and problem-solving skills in a fast-paced biotech environment.

Nice To Haves

• Prior experience with IND filings and regulatory submissions (preferred).
• Regulatory experience, including FDA/EMA interactions highly preferred.
• Established network with KOLs and clinical investigators in oncology.

Responsibilities

• Provide medical and scientific leadership for the company’s oncology programs, ensuring alignment with clinical development goals.
• Collaborate with cross-functional teams (R&D, regulatory, clinical operations, translational science, and biometrics) to develop and implement translational strategies that bridge preclinical discoveries to clinical applications.
• Lead the design, review, and oversight of clinical to evaluate drug candidates' efficacy, safety, and pharmacodynamics.
• Contribute to regulatory filings (e.g., IND submissions) by providing scientific and medical expertise, ensuring the successful progression from preclinical to clinical stages.
• Analyze and interpret clinical and correlative data to support decision-on program advancement.
• Build and maintain relationships with external KOLs, academic institutions, and clinical trial sites to support future clinical trial design and execution.
• Provide clinical insights on drug development, including patient selection strategies, safety considerations, and efficacy assessments.
• Contribute to the company’s overall strategy by identifying emerging trends and opportunities within the biotech landscape.

Benefits

• Flexible Time Off
• flexible scheduling that aligns with your needs and our objectives
• a competitive benefits package (health, commuter, and more)
• great on-site perks that include free parking, a state-of-the-art gym, and a food hall
• a collaborative, inclusive team that invests in your development and makes big things happen together

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 11-50 employees