About Kyntra Bio

Kyntra Bio is a clinical-stage biotechnology company focused on developing innovative therapies in oncology and rare disease. Our pipeline includes FG-3246 (ADC) and FG-3180 (PET imaging agent) for metastatic castration-resistant prostate cancer (mCRPC) and roxadustat (HIF-PHI) for anemia associated with lower-risk myelodysplastic syndromes (LR-MDS). Guided by scientific rigor and operational excellence, we are advancing a focused portfolio with the potential to expand treatment options for patients in need.

About the role

The Senior Medical Director will provide medical oversight for Kyntra Bio's clinical programs from Phase I through Phase III. Reporting to the Vice President, Product Development, this individual will serve as the Company's lead physician, partnering closely with Clinical Operations, Safety, Regulatory Affairs, Biometrics, and Medical Writing to support medical monitoring, study execution, clinical data review, and regulatory activities. This is a highly collaborative, hands-on role with broad responsibility for ensuring high-quality study conduct, patient safety, and successful execution of Kyntra Bio's clinical programs.

What you'll do

Key Responsibilities

• Provide medical oversight for Phase I–III clinical studies, ensuring high-quality study conduct, patient safety, protocol compliance, and regulatory adherence.
• Serve as Medical Monitor for ongoing clinical trials, providing medical guidance on patient eligibility, protocol implementation, safety assessments, and clinical decision-making.
• Partner with Clinical Operations and CROs to support study execution, site management, enrollment, protocol compliance, and issue resolution.
• Contribute to protocol development, study design, and execution planning, and lead the medical review and interpretation of clinical data.
• Collaborate with Pharmacovigilance to evaluate safety data, support safety governance activities, and contribute to safety-related regulatory documents.
• Author and review key clinical and regulatory documents, including protocols, Investigator's Brochures, clinical study reports, briefing documents, and regulatory submissions.
• Support interactions with regulatory authorities, including FDA, EMA, Health Canada, and other global health agencies.
• Build strong relationships with investigators, key opinion leaders, and clinical trial sites, representing Kyntra Bio at investigator meetings, advisory boards, and scientific conferences.
• Provide medical expertise across cross-functional teams and contribute to publications, scientific presentations, and other clinical development activities.

Qualifications

Education

• M.D., M.D./Ph.D., or equivalent medical degree required.
• Board certification or board eligibility in Oncology, Hematology/Oncology, Internal Medicine, or a related specialty preferred.

Experience

• Minimum of 6 years of pharmaceutical, biotechnology, or clinical development experience.
• Demonstrated experience in oncology drug development with expertise in solid tumors.
• Experience supporting Phase I–III clinical trials, including medical monitoring, clinical data review, and protocol development.
• Hands-on experience with clinical trial execution and global regulatory submissions (INDs, CTAs, NDAs, BLAs, and MAAs).
• Experience interacting with regulatory agencies, including FDA, EMA, Health Canada, or equivalent.
• Experience collaborating with CROs, investigators, and key opinion leaders.

Knowledge, Skills & Competencies

• Strong knowledge of Good Clinical Practice (GCP), ICH guidelines, and the clinical drug development process.
• Expertise in medical monitoring, clinical trial conduct, patient safety, and interpretation of clinical data.
• Excellent scientific writing, communication, and presentation skills.
• Demonstrated ability to build strong relationships and work effectively in a collaborative, cross-functional environment.
• Strong organizational, analytical, and problem-solving skills with exceptional attention to detail.

The pay range for this role is 325,000.00 - 395,000.00 USD per year (Remote (United States).

Kyntra Bio we continue to strive to build a diverse and equitable workplace; we share the typical the minimum and maximum salary ranges on all job postings. For annual base pay, we typically set standard salary ranges for positions based on function and level benchmarks. Further, we establish fixed annual bonus targets, expressed at % of annual base salary, based on level in the organization. Bonus awards are determined based on assessment of individual and corporate goal achievement. All compensation offers of employment are determined by multiple factors including a candidate's relevant qualifications, work experience, skills and other factors and may vary from the amounts listed above.

Notice to Recruiters and Search Firms:

Kyntra Bio does not accept unsolicited resumes or communications. Contact with a hiring manager or submission or presentation of candidates by recruiters or placement agencies without a current signed agreement with Kyntra Bio will not constitute, in any form, a financial obligation or agreement for recruitment services or placement support or consulting fees.