Director, Lead of Clinical Development

Job Purpose

Lead the Clinical Development Activities for a one or more programs or Franchises

• Responsible for the oversight, development and execution of studies linked to a worldwide clinical development plan.
• Leads the matrix team covering all clinical study activities (protocol, data cleaning, statistics, monitors, investigators, regulatory…) and also participate in pan-matrix team activities to draft regional input into world wide clinical development plans.
• Completes tasks in support of those activities as necessary, such as leading KOL and investigator recruitment processes, developing internal and external briefing documents, and other such activities requiring relevant technical expertise and clinical development experience at a senior level.
• Responsible for the clinical portion of file submission and its registration process.
• Comprehends the strategic needs of Biologicals and wider strategies for registering and marketing vaccines world-wide.
• Accountable for writing clinical expert reports, signing off regulatory documents as clinical expert, negotiating content of clinical regulatory documents with external experts.
• Coaches and develops senior and junior Clinical Development Managers that may be assigned to the project.

• Liaises internally with Regulatory, R&D, manufacturing, QA&QC, etc and externally with KOL and regulatory authorities worldwide
• Delivers comprehensive study status
• Accountable for the medical/legal and human safety aspects of the clinical program.
• Publishes clinical data in peer review journals and presents in external scientific meetings / congresses.
• Oversees preparation of investigator agreements and participates in key budget/forecast activities in collaboration with Clinical Project Manager (CPM)...
• Leads the Clinical Project teams (matrix teams including CDM’s, Science Writers, Biostats, Clin Study Coordinators, Cleaning Coordinators)
• Provide support to Marketing/Business Development throughout product life cycle
• Responsible for follow-up of project related literature, discussions with KOL and authors, participation in congresses and presenting GSK data.
• Reviews and approves labeling and related promotional materials where applicable.
• People management: within GCRD, provide leadership, direction and vision for the team of Clinical Development Management function : recruit, lead and develop the team of Clinical Development Managers, develop careers...

Profile

• MD with ability to independently research questions; sound scientific background required to critically evaluate all scientific aspects of vaccinology / immunology, or diseases
  (oncology, chronic disorders, ...)
• Over 10 years expertise in clinical research, complete familiarity with international Good Clinical Practice Guidelines, knowledge of human experimentation laws and regulations.
• Mastery of epidemiological and statistical tools
• Good technical writing and teaching skills; good stage presence for public speaking
• Executive capability to manage people and budget
• Leadership of effective matrix teams under high stress