Beschreibung
6 months contract -Medical Director -clinical development - oncologyA new opportunity has been created to support clinical development program in oncology for experienced physician with prior expertise in leading global clinical development programs.
The role is 100% home based.
Major Activities:
* Provides clinical leadership and medical strategic input for all clinical deliverables in the assigned project or section of a clinical program such as clinical sections of individual protocols consistent with the Integrated Development Plans (IDP), clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications
* Leads development of clinical sections of trial and program level regulatory documents (e.g., Investigator's Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities)
* Drives execution of the section of the clinical program in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates if applicable
* Oversees ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s)
* May act as study medical monitor
* Supports overall safety of the molecule for the assigned section, may be a core member of the Safety Management Team (SMT), and supports overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety
* As a medical expert in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (e.g., CTT, Research, Translational Medicine, Global Medical Affairs, Marketing, HE&OR), and internal decision boards
Requirements:
* Education: MD degree required.
* Advanced knowledge and clinical training in a medical/scientific area (e.g., internal medicine or sub-specialty) required, with Medical Board certification preferred;
* at least 5 years of experience in clinical research or drug development in an academic or industry environment in clinical activities in Phases I through IV.
* Prior accomplishments in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry
Advanced knowledge of oncology
* Demonstrated ability to establish strong scientific partnership with key stakeholders
* Thorough knowledge of GCP, clinical trial design, statistical analysis methodology, and regulatory/ clinical development process
Michael Bailey International is acting as an Employment Business in relation to this vacancy.