Clinical Research Director

Clinical Research Director focuses on establishes or adapts clinical development plan for the program(s) including discussions with clinical investigators, advisors and regulatory authorities and plans contingencies.

What the role involves

• Establishes or adapts clinical development plan for the program(s) including discussions with clinical investigators, advisors and regulatory authorities and plans contingencies.
• Leads, supports and oversees the execution of clinical development and studies activities, including but not limiting to.
• Reviews the Informed Consent Form, Written Subject Information and Trial Disclosure Form.
• Reviews the study specific committee charters. Leads study specific committees with operational support.
• Leads the clinical interpretation of study results, contributes to clinical study reports and clinical summaries.
• Provides effective clinical guidance to other functions, including Clinical Operations, Biostatistics and Translational Medicine.

Skills and requirements

• MD degree or equivalent, with Medical Oncology fellowship. Hematology/Oncology fellowship or experience (4+ years) in Oncology Development.
• Expertise in pharmaceutical medicine based on industry experience (3+ years) or academic clinical research experience (3+ years).
• Experience in clinical development, late-stage preferred.
• Demonstrated ability to interact productively with external investigators.

Confirmed role details

• In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.
• Check out our Diversity Equity and Inclusion actions at !

Candidate fit

• clinical judgement, NMC standards, calm communication, and careful documentation