Director, Clinical Research, Cardiovascular and Respiratory

Job Description

Our Clinical Research team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.

JOB DESCRIPTION:

Summary, Focus and Purpose  

The Cardiovascular and Respiratory Clinical Research Director has primary responsibility for planning and directing clinical research activities involving new or marketed cardiovascular and respiratory medicines. Our Company's cardiovascular and respiratory medicines span all phases of clinical development (pre-clinical to post-licensure). The Director will manage the entire cycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.

Key Functions: Specific Responsibilities

• Evaluating pre-clinical and translational work for the purpose of generating early clinical development plan and investigational new drug applications

• Creating clinical development strategies for investigational or marketed cardiovascular and respiratory drugs

• Planning clinical trials (design, operational plans, settings) based on these clinical development strategies

• Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed cardiovascular and respiratory drugs

• Analyzing and summarizing clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication

• Participating in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds

Specific Responsibilities Implementation

• Supervise the activities of Clinical Scientists in the execution of clinical studies

• Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects

• Assist the leadership team in ensuring that appropriate corporate personnel are informed of the progress of studies of our Company's and competitors' drugs

• Obtain internal and external expert opinion on scientific questions relevant to areas of responsibility

Maintain Strong Scientific Knowledge

• Maintaining awareness of scientific developments within one’s area of expertise, in terms of new scientific findings and research methodologies

• Identifying scientifically and operationally strong investigators who can assist in the development of our Company's investigational and marketed drugs

• Establishing communications with prominent clinical investigators in their particular fields of interest, particularly those who would be willing and able to assist in the evaluation of our Company drugs; and

• Attending appropriate scientific meetings to maintain one’s competency and awareness of research activities in areas of responsibility

Goal Accomplishment

• Author detailed development documents, presentations, budgets, and position papers for internal and external audiences

• Facilitate collaborations with …