Job description
Join NovaMed Research Institute, a leader in advancing specialized medicine. We are seeking a Senior Clinical Scientist to lead advanced clinical programs in Boston, MA.
In this role, you will collaborate with physicians, biostatisticians, regulatory affairs, and pharmacovigilance to design, execute, and optimize high-impact clinical trials that accelerate access to innovative therapies for patients with complex conditions.
You will be responsible for ensuring scientific rigor, patient safety, and regulatory compliance throughout study lifecycles, from protocol development to publication.
Responsibility
- Lead design and execution of phase II–IV clinical trials for selected specialized medicine programs.
- Collaborate with clinicians, biostatisticians, data managers, and regulators to develop robust protocols and analysis plans.
- Ensure GCP, ICH, and local regulatory compliance across all study activities.
- Oversee trial monitoring, safety reporting, data integrity, and audit readiness.
- Develop statistical analysis plans and oversee data analysis using SAS/R.
- Coordinate investigator meetings, site trainings, and vendor management.
- Contribute to medical writing, publications, and strategic dissemination of study results.
Qualification
- PhD in life sciences or MD/DO with specialization in clinical pharmacology or related field; or PharmD with extensive trial experience.
- Minimum 5 years of hands-on clinical research experience in specialized medicine.
- Deep knowledge of GCP, ICH guidelines, IND/CTA processes, and regulatory submissions.
- Proven track record leading trial design, execution, and cross-functional collaboration.
- Strong statistical and data management skills; proficiency with SAS, R, and CDISC standards.
- Excellent communication, leadership, and stakeholder management skills.
- Ability to manage multiple programs, timelines, and budgets with a patient-centric approach.
- Experience in medical writing and scientific publication is preferred.