Senior Clinical Research Director – Bone Marrow Transplantation

Senior Clinical Research Director – Bone Marrow Transplantation

Requirements

• Medical degree required
• Oncology and/or Hematology fellowship training or significant clinical experience (6+ years) in Oncology and/or Hematology (required)
• 5+ years clinical practice in bone marrow transplantation (required)
• 5+ years experience in translational or clinical trials as investigator in academia or study lead in industry (preferred)
• Ability to work independently and work with other team members to execute clinical development plans
• Demonstrated ability to interact productively with and attract top external investigators
• Demonstrated ability to communicate in various scientific and internal governance committees
• Understanding of and willingness to meet applicable regulatory, quality and compliance standard
• Proficiency in speaking and writing in English

Responsibilities

• Supervises study Clinical Research Directors / Clinical Scientist of assigned ongoing clinical trials
• Collaborates with cross functional teams from Clinical Operations, Medical, Biostatistics, Regulatory, Translational Medicine, Clinical Pharmacology, Health Access, Project Management and Pharmacovigilance on assigned programs
• Establishes or adapts clinical development strategy for the program including discussions with clinical investigators, advisors and regulatory authorities
• Works with GPH to evaluate business development opportunities and future clinical development programs within stem cell transplant
• Supervises the authoring of protocol extended synopses, clinical sections of Investigator Brochure, clinical sections of IND/IMPD fillings, annual reports, development risk management plans
• Leads the clinical interpretation of study results within the program, and leads the generation of clinical study reports and clinical summaries, including regulatory submissions
• Presents clinical program plans or results to health authorities, and leads response to clinical questions from health authorities
• Provides effective clinical guidance to other functions, including Clinical Operations, Biostatistics and Translational Medicine, to ensure optimal planning and execution of clinical programs within a matrix environment
• Presents and discusses clinical development strategy results with key internal stakeholders including governance bodies
• Assists the authoring of clinical abstracts, presentations for conferences, and manuscripts, when appropriate

Preferred Qualifications

• 5+ years experience in translational or clinical trials as investigator in academia or study lead in industry (preferred)