Job Title: Clinical Science Specialist
- The Clinical Science Specialist (CSS) will work within the Clinical Science (CLS) group, report to a Medical or Senior Medical Director and work collaboratively with colleagues in relevant functions such as Clinical Operations, Biometrics, Project Management, Medical Affairs, Research and Development, Pharmacovigilance and Pharmacology/Toxicology. The CSS will become a subject matter expert on a specific development program through work experience, literature review and interactions with key scientific and clinical experts. The CSS may serve in various roles, including as a point-of-contact for investigators and key opinion leaders (KOLs), liaison with internal and external committees and groups and be a clinical study team representative.
- Support study teams for assigned company investigational and marketed products; serve as CLS representative and liaise with Pharmacovigilance, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, Data Monitoring Committees (DMCs) and other internal or external entities as needed.
- Engage and establish rapport with KOLs and scientific or clinical experts.
- Stay up to date with advances in literature in therapeutic/disease area including mechanism of disease, diagnostic tests, treatment, drug development trends, and regulatory requirements.
- Collaborate with Medical/ Senior Medical Director to create and/or review slides for internal and external meetings.
- Develop scientific rationale for methods, design and implementation of clinical protocols, data collection systems and final reports.
- Work with Medical or Senior Medical Directors to assist in the development of key documents to support the components of trial execution and regulatory submission (including IND Annual Reports, Investigator Brochures, Briefing Books and Pediatric plans).
- Design, update and implement Clinical Development Plans (CDPs), and work with Project Management to ensure progress in line with current plans and timelines.
- Help define study quality metrics and perform medical data reviews during study execution to ensure integrity of accruing study data.
- PharmD, PhD in pharmaceutical, life sciences or nursing, or equivalent.
- 1-2 years of clinical or translational research or equivalent post-graduate experience
- An advanced clinical/science degree (PhD, PharmD or equivalent).
- Post-graduate clinical experience or pharmaceutical industry experience
- Superb oral and written communication skills, with experience in submission of scientific publications (peer reviewed abstracts and papers)
- Knowledge of clinical trial design and clinical development processes
- Familiarity with relevant documents and processes, including INDs, BLAs, NDAs, PIPs, CRFs, CSRs.
- Familiarity with GCP, ICH, and other relevant guidelines.
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance