Job description
NovaThera Biomed is a leader in specialized medicine, partnering with physicians to deliver cutting-edge therapies and diagnostics. We are currently seeking a Senior Specialist in Specialized Medicine to join our clinical development and translational research programs in Boston. The ideal candidate will combine clinical insight with research acumen to drive patient-centric programs from concept to execution.
As a key member of our medical affairs and research teams, you will contribute to strategy, protocol design, and data interpretation while ensuring rigorous adherence to regulatory and ethical standards.
We offer a collaborative culture, competitive compensation, and opportunities for professional growth in a thriving Boston biotechnology ecosystem.
Responsibility
- Lead and coordinate multicenter clinical studies and trials in specialized medicine, ensuring protocol compliance and data integrity.
- Collaborate with physicians, scientists, and regulatory teams to design study plans, endpoints, and safety monitoring plans.
- Oversee adverse event reporting, risk assessment, and pharmacovigilance activities in compliance with GCP and regulatory requirements.
- Analyze clinical data, generate actionable insights, and present findings to internal and external stakeholders.
- Contribute to medical affairs strategy, publications, and abstracts for conferences.
- Mentor junior team members and provide medical leadership in cross-functional project teams.
- Ensure patient safety, ethical conduct, and privacy as per HIPAA and institutional guidelines.
Qualification
- MD or DO with board certification in a relevant specialty; or PhD with clinical and translational medicine experience.
- 5+ years of experience in specialized medicine, clinical research, or related fields.
- Strong knowledge of GCP, regulatory affairs, IRB processes, and pharmacovigilance.
- Proven ability to design and manage complex clinical studies and interpret results.
- Excellent communication skills for scientific writing, presentations, and cross-functional collaboration.
- Proficiency with statistical software and data visualization tools; experience with EDC systems and SQL is a plus.