Ref No: AM17282
Co. Dublin, Ireland
Senior Director - Clinical Research.
In this role you will design, conduct, and evaluate Phase 1, 2, and 3 clinical trials and provide scientific expertise on paediatric viral infectious diseases.
Interface with staff to share scientific and clinical information and consistent practices.
Lead/support protocol review discussions concerning scientific and procedural aspects of study design.
Serve as resource for junior staff.
Oversee the scientific aspects of clinical studies throughout duration of study.
Adhere to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as organisational SOP's.
Prepare study protocols, amendments, specific sections of study manuals and Investigator meeting notebooks, and other documents as needed.
Supervise or assist other CR staff with preparation of above. Contribute to the design and development of CRF's, Data Management Manuals and Data Analysis Plans.
Help ensure consistency across protocols.
Present scientific information if needed.
Address questions regarding scientific and related procedural issues from Investigators.
Coordinate and implement ongoing data for internal analysis and review.
Coordinate/support the preparation/review of regulatory documents, PIP's/PSP's, safety reports, Investigator Brochures, and NDA's.
Determine the functions most critical to company success and support priorities within the functional area.
Anticipate complex obstacles and implement solutions that meet goals.
Create effective teams with a clear sense of direction.
Interested applicants should have:
A higher degree MD, with significant years' experience in clinical research or clinical pharmacology in a pharmaceutical company, contract research organisation or academic institution
Experience in paediatric medicine and/or paediatric drug development is highly desirable but not essential
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.
Ability to examine functional issues from a broader organisation 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
Pharmaceutical/Biotech industry experience in clinical development preferred
Successful leadership and management experience
Excellent organisational and communication skills are critical