Job description
Join NovaThera Biomed Solutions as a Senior Specialist in Specialized Medicine. This high-impact role is tailored for experienced researchers and clinicians focused on translational science, rare diseases, and next-generation therapies. Based in Boston, MA, you will collaborate with clinical operations, regulatory affairs, data science, and medical affairs to advance innovative treatments from bench to bedside.
We offer a collaborative, high-performance environment with access to cutting-edge platforms, robust patient cohorts, and meaningful opportunities to publish and present findings. This position supports hybrid work arrangements and structured professional development to accelerate your career in specialized medicine.
Responsibility
- Lead design and oversight of early- and late-phase clinical studies in specialized medicine, ensuring scientific rigor and patient safety.
- Collaborate with cross-functional teams to translate preclinical data into clinical development strategies and trial protocols.
- Develop and manage study milestones, metrics, and risk mitigation plans in alignment with regulatory requirements (FDA, EMA).
- Oversee protocol development, statistical analysis plans, and data interpretation to inform decision-making.
- Ensure compliance with GCP/GLP, ICH guidelines, and institutional policies across sites.
- Prepare high-quality scientific communications, manuscripts, and presentations for external stakeholders.
- Contribute to regulatory submissions, safety reporting, and pharmacovigilance processes.
- Mentor junior team members and represent the function in cross-departmental governance reviews.
Qualification
- Advanced degree in Medicine, Pharmacology, or related field; MD or PhD preferred.
- Minimum 5-7 years of clinical research, translational medicine, or regulatory-facing experience in specialized therapeutic areas.
- Proven track record in designing and executing clinical trials, with strong data interpretation skills.
- In-depth knowledge of GCP/GLP, ICH guidelines, and regulatory submission processes (FDA/EMA).
- Demonstrated ability to lead cross-functional teams, manage budgets, and drive on-time delivery.
- Excellent scientific writing, presentation, and communication skills.
- Proficiency with data analysis tools (SAS/R) and clinical trial management systems (CTMS).
- Reliable collaboration, problem-solving mindset, and commitment to patient safety and ethics.