About the roleThe 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 doKey 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.
QualificationsEducation- 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).
