Clinical Development Physician
The Clinical Development Physician (CDP) has primary responsibility for the planning and execution of clinical research programs involving novel therapies. Products may span all phases of clinical development (Phase 1 to Phase 3). The CDP will collaborate with key stakeholders to develop and manage the entire cycle of clinical development, including: study design, study execution, monitoring, analysis, regulatory interactions, and study reporting, and publication.
· Lead the development of clinical development plans for investigational drugs as the clinical/medical expert
· Monitor and manage the conduct of clinical trials for investigational drugs
· Analyze and summarize the clinical findings from studies to support decisions regarding safety and efficacy. Be the clinical expert for study documents, clinical study reports, regulatory documents, or publications
· Participation in internal and joint internal/external project teams relevant to the development of new compounds
· Be the clinical expert and work closely with a cross-functional group of experts in operations, regulatory affairs, statistics, data management, manufacturing, medical affairs, commercial on assigned projects
· Maintaining awareness of scientific developments within his/her area of expertise, in terms of new scientific findings, research methodologies
· 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 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
· Contribute to the assessment of business development opportunities
· Facilitate collaborations with external researchers around the world
· Travel on company business to manage future or ongoing clinical development projects.
Experience & Education
· MD degree with a minimum of 5-7 years relevant clinical development experience in biotechnology/pharmaceutical industry; therapeutic experience in autoimmune disease areas and/or immuno-oncology is preferred
· Must have relevant and substantial experience in the design of clinical studies, review of data quality, safety monitoring, and the execution of trials
· Must have a demonstrated ability to solve problems with innovative solutions along with strong organizational skills.
· Must have knowledge of effective competitive strategies as well as an in-depth understanding of clinical product development in the pharmaceutical industry.
· Strong analytical skills, especially with regard to understanding and interpreting scientific research and literature are essential.
· Experience and understanding of ICH, and GCP is required. Knowledge of GMP and GLP is preferred.
· Must be a demonstrated self-starter and team player with strong interpersonal skills. Must possess excellent project management skills and be a strong team leader
· Title (e.g Director-Senior Director) commensurate with background and experience