Distinguished Scientist, Clinical Research, Thoracic Malignancies
About the position Our Clinical Development teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards. The Distinguished Scientist (Executive Director) and Product Development Team (PDT) Lead, Oncology Global Clinical Development, has primary responsibility for the planning and directing clinical research activities involving new or marketed drugs in the Oncology Clinical Research group and in the field of Thoracic Oncology. The Executive Director, PDT Lead will manage the entire cycle of clinical development, including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international meeting. They will provide internal scientific leadership for cross-functional areas supporting clinical trials and will interact externally with key opinion leaders. Specifically, the Executive Director, PDT Lead may be responsible for: Evaluating pre-clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug applications. Developing clinical development strategies for investigational or marketed agents 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 agents 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 Participation in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds and support of business development assessments of external opportunities. Provide support for other therapeutic areas regarding clinical issues related to oncology compounds. The Executive Director, PDT Lead may: Manage Directors and/or Senior Directors responsible for Oncology Global Clinical Development projects. Supervise the activities of entire Clinical Teams in the execution of clinical studies. Will report to and work collaboratively with the Section Head to promote the development strategy of the company on the indication of interest. Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, medical affairs and manufacturing to manage clinical development projects; and assist the Section Head in ensuring that appropriate Corporate personnel is informed of the progress of studies of our company and competitors' drugs and 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 Identification of 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 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, PDT Lead may: Author detailed development documents, presentations, budgets, and position papers for internal and external audiences Facilitating 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.
Responsibilities
- Evaluating pre-clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug applications.
- Developing clinical development strategies for investigational or marketed agents 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 agents
- 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
- Participation in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds and support of business development assessments of external opportunities.
- Provide support for other therapeutic areas regarding clinical issues related to oncology compounds.
- Manage Directors and/or Senior Directors responsible for Oncology Global Clinical Development projects.
- Supervise the activities of entire Clinical Teams in the execution of clinical studies.
- Will report to and work collaboratively with the Section Head to promote the development strategy of the company on the indication of interest.
- Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, medical affairs and manufacturing to manage clinical development projects; and assist the Section Head in ensuring that appropriate Corporate personnel is informed of the progress of studies of our company and competitors' drugs and internal and external expert opinion on scientific questions relevant to their areas of responsibility.
- Maintaining awareness of scientific developments within their area of expertise, in terms of new scientific findings, research methodologies
- Identification of 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 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.
- Author detailed development documents, presentations, budgets, and position papers for internal and external audiences
- Facilitating 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.
Requirements
- M.D or M.D./Ph.D.
- Must have experience in industry in the field of Thoracic Oncology
- Minimum of 3 years of clinical medicine experience
- Minimum of 5 years of industry experience in drug development
- Demonstrated record of scientific scholarship and achievement
- A proven track record in clinical medicine and background in biomedical research is essential
- Strong interpersonal skills, as well as the ability to function in a team environment, are essential.
- Clinical Development
- Clinical Judgment
- Clinical Medicine
- Clinical Research
- Clinical Trial Planning
- Clinical Trials
- Cross-Cultural Awareness
- Cross-Functional Teamwork
- Drug Development
- Ethical Standards
- Medical Research
- Oncology
- Pulmonology
- Regulatory Requirements
- Research Methodologies
- Scientific Consulting
- Scientific Leadership
- Scientific Research
- Strategic Leadership
Nice-to-haves
- Board Certified or Eligible in Oncology (and/or Hematology)
- Prior specific experience in clinical research and prior publication
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
- annual bonus and long-term incentive, if applicable
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