Clinical Director, Clinical Research, Hematology
About The Position
The Clinical Director (Principal Scientist) has primary responsibility for planning and directing clinical research activities involving new or marketed medicines in the Oncology therapeutic area, specifically in the Hematology Section. The company’s Oncology medicines span all phases of clinical development, from pre-clinical development to post-licensure. The Clinical Director may manage the full cycle of assigned clinical development studies, including study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication. The role includes medical oversight and overall conduct of clinical trials, analysis and communication of study findings to support safety and efficacy decisions and regulatory or publication needs, and participation in internal and external research teams. The Clinical Director works with cross-functional experts and external researchers, provides scientific expertise, and maintains current knowledge of developments and research methods in their field. The role also involves identifying and engaging clinical investigators, preparing development documents and presentations, and traveling on company business approximately 20% of the time.
Requirements
- M.D. or M.D./Ph.D.
- Experience in industry or as senior faculty in academia.
- At least 3 years of clinical medicine experience.
- At least 1 year of industry experience in drug development or biomedical research experience in academia.
- Demonstrated record of scientific scholarship and achievement.
- Proven track record in clinical medicine and a background in biomedical research.
- Strong interpersonal skills and ability to function in a team environment.
- Strong verbal and written communication and presentation skills.
- Required skills include academic presentations, adaptability, allergy and immunology, biomedical research, clinical investigations, clinical judgment, clinical research, clinical trial planning, clinical trial support, cross-functional teamwork, ethical standards, intellectual curiosity, new technology integration, regulatory requirements, and scientific consulting.
Nice To Haves
- Board certified or board eligible in Oncology, Hematology, or a related discipline.
- Prior specific experience in clinical research and prior publication.
Responsibilities
- Plan clinical trials, including study design and collaboration on operational plans, based on clinical development strategy.
- Provide medical oversight and responsibility for the overall conduct of ongoing or new clinical trials involving investigational or marketed drugs.
- Analyze and summarize clinical study findings to support safety and efficacy decisions, new drug applications, clinical study reports, and publications.
- Participate in internal and joint internal/external research project teams concerning new compounds and further study of marketed compounds.
- Support business development assessments of external opportunities.
- Engage with other functional areas to support study execution.
- Work with cross-functional experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects.
- Help ensure colleagues are informed about the progress of company and competitor drug studies.
- Provide expert opinions internally and externally on relevant scientific questions within the role’s area of responsibility.
- Maintain awareness of scientific developments and research methodologies in the area of expertise.
- Identify strong scientific and operational investigators who can support development of investigational and marketed drugs.
- Establish communications with prominent clinical investigators in the field, particularly those able to assist in evaluating the company’s drugs.
- Attend scientific meetings to maintain competency and awareness of research activity in the area of responsibility.
- Author development documents, presentations, budgets, and position papers for internal and external audiences.
- Facilitate collaborations with external researchers around the world.
- Travel on company business approximately 20% of the time to manage future or ongoing clinical research projects.
Benefits
- Medical, dental, and vision healthcare benefits and other insurance benefits for employees and families.
- Retirement benefits, including 401(k).
- Paid holidays, vacation, compassionate days, and sick days.
- Eligible for annual bonus and long-term incentive, if applicable.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
