[Remote] Clinical Director, Clinical Research, Ophthalmology
Note: The job is a remote job and is open to candidates in USA. Merck is a leading pharmaceutical company, seeking a Clinical Director for Clinical Research in Ophthalmology. The Clinical Director will be responsible for planning and directing clinical research activities, managing the entire cycle of clinical development for assigned studies, and collaborating with cross-functional teams to ensure successful study execution.
Responsibilities
- 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
- 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; and
- Assist the team in ensuring that other colleagues are informed of the progress of studies of our company and competitors' drugs, and
- Provide expert opinion, internally and externally, on relevant scientific questions within their responsibility
- 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, particularly those who will be willing and able to assist in the evaluation of our company's drugs
- Attending appropriate scientific meetings to maintain his or her competency and to maintain awareness of research activities in his/her area of responsibility
- 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
Skills
- 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
- 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
- Board Certified or Eligible in ophthalmology or related discipline
- Prior specific experience in clinical research and prior publication
Benefits
- Annual bonus and long-term incentive, if applicable
- Medical, dental, vision healthcare and other insurance benefits (for employee and family)
- Retirement benefits, including 401(k)
- Paid holidays, vacation, and compassionate and sick days
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