Job description
At VitaNova Therapeutics, we are at the forefront of Specialized Medicine, translating cutting edge research into life changing therapies. We are seeking a Senior Clinical Research Scientist to lead, design, and execute complex studies across diverse therapeutic areas. This is a high impact, cross functional role for a scientist who thrives in a fast paced, data driven environment. You will partner with clinical operations, biostatistics, regulatory affairs, and translational science teams to bring innovative treatments from concept to regulatory submission and patient care.
Responsibility
- Lead design and oversight of early and late phase clinical studies in Specialized Medicine, ensuring scientific rigor and regulatory alignment.
- Collaborate with cross functional teams (Clinical Operations, Pharmacovigilance, Biostatistics, Regulatory) to drive study milestones.
- Develop study protocols, case report forms, and statistical analysis plans; oversee data quality and integrity.
- Interpret clinical data, prepare clinical sections of regulatory submissions, and contribute to publications and presentations.
- Mentor junior scientists and coordinate with CROs and vendors for meticulous trial execution.
- Monitor safety data and ensure compliance with ICH-GCP, FDA/EMA guidelines, and internal SOPs.
- Drive strategic initiatives for patient centric trial design and real world evidence generation.
Qualification
- PhD or MD in life sciences (PharmD, DMD) with 5+ years of clinical research experience in Specialized Medicine (e.g., oncology, neurology, immunology).
- Demonstrated success leading multi site clinical trials and regulatory submissions.
- Strong knowledge of ICH-GCP, FDA/EMA guidelines, and risk based monitoring.
- Experience with statistical software (SAS, R) and data management systems (EDC, IC/IRB processes).
- Excellent scientific writing and presentation skills; proven track record of publications and conference presentations.
- Ability to lead, influence cross functional teams, and manage external vendors/CROs.
- Eligibility to work in the United States; willingness to travel up to 25% as needed.