Job description
NovaMed Therapeutics is at the forefront of specialized medicine, focusing on rare diseases and personalized therapies. We seek a Clinical Research Scientist to lead clinical programs from discovery to regulatory submission, collaborating across medical affairs, translational science, biostatistics, and operations to bring transformative treatments to patients.
In this role, you will shape strategy, design trials, ensure compliance, and drive the medical plan with a patient-centric approach. You will contribute to publications, safety monitoring, and cross-functional communications with investigators, CROs, and regulatory bodies.
We offer a competitive compensation package, flexible work options, and a clear path for growth within a dynamic, science-driven environment in Boston.
Responsibility
- Lead design and execution of early- to late-phase clinical trials for rare diseases, ensuring scientific rigor and patient safety.
- Develop and finalize study protocols, informed consents, and case report forms in collaboration with cross-functional teams.
- Ensure ICH-GCP compliance, regulatory submissions, ethics approvals, and timely safety reporting.
- Manage vendor relationships (CROs, central labs) including scope, budget, milestones, and performance.
- Oversee data quality, pharmacovigilance plans, and safety monitoring; contribute to CSR and medical publications.
- Interpret clinical data and communicate findings to internal stakeholders; support regulatory filings and submissions.
- Foster cross-functional collaboration (Medical Affairs, Translational Science, Biostatistics) to drive strategy and risk management.
- Lead authoring of clinical study reports, publications, and conference abstracts.
Qualification
- MD or DO or PhD in life sciences; 5+ years in clinical research or medical affairs in specialized medicine or rare diseases.
- Deep knowledge of ICH-GCP, FDA/EMA regulations; experience with regulatory submissions and IRB/ethics committees.
- Proven ability to design and manage clinical trials, including protocol development, CRFs, and study metrics.
- Strong data interpretation and statistical understanding; proficiency with SAS/R is a plus.
- Excellent written and verbal communication; proven medical writing skills; track record of publications.
- Demonstrated vendor management and cross-functional collaboration experience; ability to lead cross-disciplinary teams.
- Willingness to travel up to 20–25% and work in a fast-paced, matrixed environment.
- Commitment to patient-centric approach and ethical standards.