Senior Clinical Director, Clinical Research, Hematology

Overview

Senior Clinical Director (Senior Principal Scientist) has primary responsibility for planning and directing clinical research activities involving new or marketed medicines in the Oncology therapeutic area, specifically in our Hematology Section. Our company's Oncology medicines span all phases of clinical development (pre‑clinical to post‑licensure). The Senior Clinical Director may manage the entire cycle of clinical development for their assigned studies including study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.

• 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 Hematology drugs.
• 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 the 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.
• Assist the Executive Director and/or Associate Vice President in ensuring that appropriate personnel 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.
• Maintaining awareness of scientific developments within their 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 the 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 competency and awareness of research activities in the area of responsibility.
• Authoring detailed development documents, presentations, budgets, and position papers for internal and external audiences.
• Facilitating collaborations with external researchers worldwide.
• Traveling on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects.

• M.D. or M.D./Ph.D.

• Must have experience in industry or as senior faculty in academia.
• Minimum of 3 years clinical medicine experience.
• Minimum of 3 years industry experience in drug development or biomedical research experience in academia.
• Demonstrated success in overseeing clinical studies and protocols.
• 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.
• Outstanding verbal and written communication and presentation skills.

• Board Certified or Eligible in Oncology, Hematology or related discipline.
• Prior specific experience in clinical research and prior publication.

• Clinical Development
• Clinical Documentation
• Clinical Judgment
• Clinical Medicine
• Clinical Reporting
• Clinical Research Management
• Clinical Trial Development
• Clinical Trials
• Data Analysis
• Decision Making
• Drug Development
• Early Clinical Development
• Ethical Standards
• Hematology
• Hemodialysis
• Hemodynamic
• Intellectual Curiosity
• Interdisciplinary Problem Solving
• Mentorship
• Nephrology
• Regulatory Affairs…