GeneCoda has been engaged to identify and evaluate candidates, for a Clinical Scientist to be located in the RTP, NC area.
About Our Client:
Our client is a growing pharmaceutical company with a strong technological platform that develops compounds focusing on orphan and rare diseases. Our client has numerous collaborations and in-license relationships with premier research institutions, the US government, and global partners.
The Clinical Scientist is responsible for the conduct and reporting of assigned clinical studies across all clinical development phases and commercialization. The Clinical Scientist is responsible for medical and scientific oversight of the design, planning, initiation and successful completion of clinical trials.
- Collaborate with clinical operations and CRO’s to develop clinical research documents, including protocols, case report forms (CRF’s), informed consent templates, clinical study reports (CSR’s), feasibility assessments, and site selection strategies, in collaboration with the Clinical Operations team and study statisticians.
- Author, edit and review medical and scientific elements of clinical research and regulatory documents.
- Develop and maintain relationships with leading investigators and clinical sites on protocols and medical and scientific aspects of studies.
- Work with clinical operations and CRO’s on appropriate measures to further timely recruitment, site enthusiasm, and motivation of site staff.
- Participate in the development of publication strategies, writing, and editing of draft presentations and manuscripts and interface with investigators.
- Provide input and feedback on promotional material, labeling, and training material.
MD, Ph.D., or PharmD preferred.
- 5+ years of experience in clinical research including clinical protocol design and execution.
- Prior pharmaceutical/biotechnology industry experience is required.
- Prior experience in orphan or rare disease sets is preferred.
- Global product launch and late stage (PIII) trial experiences are preferred.
- Demonstrated ability to understand, influence, collaborate and lead in a diverse team-based organization.
- Strong time management, project management, and organizational skills.
- Excellent communication and presentation skills along with the ability to interface with management, peers, vendors, and investigators.
- Strong team player, with proven ability to contribute to a multi-disciplinary team environment.
- Experience with research collaborations.
- Self-starter, energizing, results-oriented, and able to multi-task.
GeneCoda refers qualified applicants for all jobs without regard to race, color, religion, creed, age, sex, disability, marital status, national origin, pregnancy, family medical history or genetic information, sexual orientation or preference, Vietnam Era Veteran status or other protected military status or any other status protected by federal, state or local law.