Clinical Development Physician
An exciting opportunity has arisen for Clinical Development Physician to join a global pharmaceutical company in Dublin. In this position you will be looking to design, conduct and evaluate Phase I-III clinical trails and provide expertise on paediatrics diseases.
- Interfaces with staff to share scientific and clinical information and consistent practices.
- Leads/supports protocol review discussions concerning scientific and procedural aspects of study design.
- Serves as resource for junior staff.
- Oversees the scientific aspects of clinical studies throughout duration of study.
- Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.
- Prepares study protocols, amendments, specific sections of study manuals and Investigator meeting notebooks, and other documents as needed.
- Supervises or assists other CR staff with preparation of above. Contributes to the design and development of CRFs, Data Management Manuals and Data Analysis Plans.
- Helps ensure consistency across protocols.
- Presents scientific information if needed.
- Addresses questions regarding scientific and related procedural issues from Investigators.
- Coordinates and implements ongoing data for internal analysis and review.
- Coordinates/supports the preparation/review of regulatory documents, PIPs/PSPs, safety reports, Investigator Brochures, and NDAs.
- Determines the functions most critical to company success and supports priorities within functional area.
- Anticipates fairly complex obstacles and implements solutions that meet goals.
- Creates effective teams with a clear sense of direction.
- May lead two or more specific components of departmental strategic initiatives.
Skills and Requirements
- Typically requires a higher degree MD, with significant years in clinical research or clinical pharmacology in a pharmaceutical company, contract research organization or academic institution
- Excellent verbal and written communication skills and interpersonal skills are required to maintain working relationship with team members to ensure scientific integrity of clinical studies.
- Examines functional issues from a broader organization perspective.
- Knowledge of clinical trial design to develop specific study concept sheets and protocols is required.
- Familiarity with virology and HIV medicine preferred
- Clinical or translational research experience preferred
- Successful leadership and management experience
- Excellent organizational and communication skills are critical
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.