Executive Director, Product Development Team Leader, Clinical Research, Atherosclerosis

Job Description

The Executive Director (Distinguished Scientist) has primary responsibility for the planning and directing of clinical research activities involving new or marketed medicines in the Atherosclerosis section of the Atherosclerosis & Metabolism therapeutic area. The Executive Director will manage and oversee the entire cycle of late stage clinical development from Phase 2 to Phase V, including development of program strategy and design, protocol authoring, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international meeting. They will lead cross-functional product development teams that oversee program strategy and execution, will provide internal scientific leadership for cross-functional areas supporting clinical trials, and will interact externally with key opinion leaders. 

Specifically, the Executive Director may be responsible for:

• Evaluating pre-clinical and translational work for the purpose of generating early clinical development plans and Investigational New Drug applications

• Developing clinical development strategies for investigational or marketed medicines that incorporate the latest scientific developments, regulatory requirements, the competitive landscape, and commercial considerations

• 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 medicines

• Leading cross-functional product development teams that oversee overall strategy and execution for investigational or marketed medicines

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

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

• Supporting business development assessments of external opportunities.

• Managing other Directors and/or Senior Directors responsible for Atherosclerosis clinical development projects

The Executive Director may 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, and assist the Associate Vice President and/or Vice President in ensuring that appropriate Corporate personnel are informed of the progress of studies of our company and competitors' drugs, and of internal and external expert opinion on scientific questions relevant to their areas of responsibility.

The Executive Director is responsible for maintaining a strong scientific fund of knowledge by:

• Maintaining awareness of scientific developments within their area of expertise, in terms of new scientific findings, 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 field of interest, particularly those who will be willing and able to assist in the evaluation of our company's drugs

• Attending appropriate scientific meetings to maintain their competency and to maintain awareness of research activities in their area of responsibility.

To accomplish these goals, the Executive Director may:

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

• Facilitate collaborations with external researchers around the world

• Travel on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects.

Education:

• M.D or M.D./Ph.D.

Required Experience and Skills:

• Minimum of 3 years of clinical medicine experience

• Minimum of 5 years of industry experience in drug development with demonstrated success in overseeing multiple studies and protocols through completion, and experience in authoring regulatory documents and leading discussions with regulatory agencies

• Demonstrated record of scientific scholarship and achievement

• Proven track record in clinical medicine and background in biomedical research

• Outstanding interpersonal and collaborative skills, as well as the ability to function in a matrix environment<