Clinical Research Director

Main Responsibilities

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:
Authors abbreviated protocol.
Reviews the final protocol and protocol amendments.
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.
Participates and contributes to regulatory and safety documents and discussions.
Reviews and/or contributes clinical sections of the Investigator Brochure, IND/IMPD filings, DSUR, development risk management plans.
Contributes to the clinical sections of the NDA/CTD, Briefing packages for regulatory meetings, PSP/PIPP.
Participates in Advisory Committee preparation
Scientific data evaluation and authorship.
Authors clinical abstracts, presentations for conferences, and manuscripts, when appropriate.
Supports the planning of advisory board meeting.
Presents and discusses development strategy and clinical study result with external investigators and advisory boards, as appropriate.

About You

Job Requirements:
MD degree or equivalent.
Minimum 3 years industry or academic clinical development experience.
Hematology/Oncology experience preferred.
Demonstrated ability to work with a multifunctional team to achieve project milestones.
Understanding of and willingness to meet applicable regulatory, quality and compliance standards.