Clinical Research Medical Director - Oncology

Responsibilities

• Supporting the development, execution and communication of the global scientific/medical evidence plan
• Supporting cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program
• Supporting the development of key scientific external relationships with opinion leaders
• Participating and providing clinical input into safety and regulatory interactions
• Provide clinical/scientific input during the development and execution of clinical trials
• Interpret clinical trial data
• Participate in safety assessments
• Participate in interactions with regulatory agencies
• Author CSRs, publications and regulatory submissions
• Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by Global Development Leader
• Identify new clinical research opportunities
• Support in-licensing and out-licensing activities and partner relationships
• Support product lifecycle management for new indications as directed by Global Development Leader
• Provide clinical content input to:
  • Regulatory interactions and documents
  • Safety interactions and documents
  • Materials to be used in Scientific Affairs
  • Materials to be used by the Commercial Organization

Qualifications

• Required: MD or DO degree from an accredited medical school
• Required: 2 years of clinical research experience and/or basic science research
• Preferred: 5+ years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities, particularly in GU Oncology (prostate cancer)
• Preferred: Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)
• Preferred: In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale
• Preferred: Familiarity with concepts of clinical research and clinical trial design, including biostatistics
• Preferred: Sound scientific and clinical judgment
• Preferred: Knowledge of Good Clinical Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable international regulatory requirements
• Preferred: Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication
• Preferred: Demonstrated ability as a medical expert in a complex matrix environment
• Preferred: History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues