Associate Clinical Development Medical Director (Cardiovascular)
- Experience Level
Our global pharmaceutical client has a vacancy for a Associate Clinical Development Medical Director (Cardiovascular).
Our client is looking for candidates based in Switzerland/ EU.
This is an initial 6-month full time contract.
The Associate Clinical Development Medical Director is responsible for the scientific and medical strategy of assigned clinical trial(s), medical and scientific monitoring, and reporting of quality data. May be responsible for the scientific and medical strategy of assigned sections of a clinical development program, depending on the size and complexity.
1) Provides clinical leadership, medical and scientific strategic input, and contributes to development of trial related documents (e.g., CTPs, informed consent form, case report forms, data monitoring committee charters, data analysis plan, reports, publications) for assigned clinical trial(s) consistent with Integrated Development Plan (IDP); develops materials for trial-related advisory boards, data monitoring committees, investigator meetings, and protocol training meetings
2) Provides medical and scientific input and contributes to clinical sections of trial and program level regulatory documents (e.g., Investigator’s Brochures, Health Authority briefing books, safety updates, submission dossiers, and responses to Health Authorities)
3) In collaboration with appropropriate Clinical Trial Team (CTT) members:
a) Ensures direct medical support of trials as needed and may act as medical monitor
b) Conducts ongoing medical and scientific review of clinical trial data with Clincal Scientific Expert(s)
c) Manages patient safety and reports on trial data to safety and clinical boards (e.g., Safety Management Team (SMT), GCT, GPT)
d) Provides input into final analyses and interpretation including the development of the Clinical Study Report(s) (CSRs), publications and internal/external presentations
MD or equivalent medical 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; Clinical practice experience ≥ 4 years (including residency) preferred
Languages: Fluent English (oral and written)
• ≥ 3 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV. ≥ 2 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry
• Working knowledge of the assigned disease area is desired with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) or program level
• Demonstrated ability to establish effective working relationship with key investigators
• Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes
• Strong communication skills, written and oral
• Strong interpersonal skills
• Strong negotiation and conflict resolution skills
• Proven ability to work independently or in a cross-functional team setting
Contractor to support a Cardiovascular Outcome Trial in the Metabolism TA.