[Hiring] Clinical Director, Clinical Research, Ophthalmology @MSD

Role Description

The Clinical Director (Principal Scientist) has primary responsibility for planning and directing clinical research activities involving new or marketed medicines in the ophthalmology therapeutic area. Our company's ophthalmology medicines span all phases of clinical development (pre-clinical to post-licensure).

The Clinical Director may manage the entire cycle of clinical development for their assigned studies including:

• Study design
• Initiation
• Execution
• Monitoring
• Analysis
• Regulatory reporting
• Publication

Specifically, the Clinical Director may be responsible for:

• Planning clinical trials (designing, collaborating on operational plans, etc.) based on the clinical development strategy
• Medical oversight and overall conduct of ongoing or new clinical trials for investigational or marketed 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
• Supporting business development assessments of external opportunities

The Clinical Director may:

• Actively engage with other functional areas in support of study execution
• Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects
• Assist the team in ensuring that other colleagues are informed of the progress of studies of our company and competitors' drugs
• Provide expert opinion, internally and externally, on relevant scientific questions within their responsibility

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

• Maintaining awareness of scientific developments within his/her 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 his/her particular field of interest
• Attending appropriate scientific meetings to maintain his or her competency and to maintain awareness of research activities in his/her area of responsibility

To accomplish these goals, the Clinical Director may:

• Author 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 25% percent of the time to manage future or ongoing clinical research projects

Qualifications

• M.D or M.D./Ph.D.
• Must have experience in industry or faculty in academia
• Minimum of 3 years of clinical medicine experience
• Minimum of 1 year of industry experience in ophthalmology drug development or biomedical research experience in academia focused on ophthalmology
• Demonstrated record of scientific scholarship and achievement
• Proven track record in clinical medicine and background in biomedical research
• Strong interpersonal skills, as well as the ability to function in a team environment
• Strong verbal and written communication and presentation skills

Requirements

• Biomedical Research
• Clinical Development
• Clinical Documentation
• Clinical Investigations
• Clinical Medicine
• Clinical Reporting
• Clinical Research
• Clinical Trial Planning
• Clinical Trials
• Clinical Trial Support
• Cross-Functional Teamwork
• Drug Development
• Early Clinical Development
• Ethical Standards
• Ophthalmology
• Optometry
• Regulatory Requirements
• Research Methodologies
• Scientific Publications

Benefits

• Medical, dental, vision healthcare and other insurance benefits (for employee and family)
• Retirement benefits, including 401(k)
• Paid holidays
• Vacation
• Compassionate and sick days