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Senior Director, Immunology Clinical Development

Reference Number: 2798
Location: NJ

Our client is a global pharmaceutical company addressing unmet medical needs.  They have asked us to assist them in their search for a Senior Director, Immunology Clinical Development.

The Senior Director, Immunology Clinical Development is responsible for providing leadership to the international project team, which is accountable for the clinical development of a drug in the acute liver indication.  This person will provide clinical expertise, oversight, and direction for the ongoing Phase 3 program, which needs to be conducted by an experienced clinical study director and medical monitor.  The position also involves overall clinical leadership for this indication, including preparation of the registration dossiers for this indication in the US, EU, and Japan.  LCM opportunities will also be the responsibility of the individual in this position.

Major tasks and responsibilities will include:

  • Designs and provides oversight of clinical research plans and programs to include integrated regulatory and biomarker strategies.
  • Leads the development and execution of the CDP and DDP Clinical Research Protocols.
  • Leads the development of Clinical Protocols to meet the CDP objectives.
  • Oversees and resolves operational aspects of clinical studies in conjunction with project and study teams and in accordance with SOP, GCP and regional regulations.
  • Reviews and monitors safety data from a clinical program and identifies trends and signals.
  • Develops strategies to identify, monitor and resolve clinical program/trial issues.
  • Serves as SME to management (for marketing or research functions) and regulatory agencies, sets the strategy for Advisory Boards, and builds strong relationships with international KOLs.
  • Interprets study data and develops integrated summaries of safety and efficacy.
  • Provides scientific leadership for regulatory documents creation (e.g. briefing books, NDAs etc.)
  • Represents Clinical in discussions with Health Authorities.
  • Integrates and implements new resources (tools, systems, vendor, etc.) and techniques with existing ones.
  • Sets overall deadlines for projects within function and tracks project milestones.
  • Manages contractors and ensures completion of assigned work according to agreed timelines.
  • Makes appropriate budgetary allocations to targeted opportunities.
  • Reviews and escalates changes in program/ department budget.
  • Reviews 3rd party (contractors, consultants and vendors) work product and deliverables to approve payment Matrix and Team Management.
  • Champions effective coaching and development planning in a way that fosters a culture of proactive people development at the company.
  • Manages all employee-related activities throughout the year, including performance management and development, compensation planning, internal talent assessment and succession planning as well as recruitment and selection for functional group.
  • Complies with all applicable laws/regulations of each country in which our client does business and demonstrates high ethical behavior at all times.

We seek candidates with the following qualifications:

  • MD is required.  MD/PhD preferred.
  • Extensive experience in Clinical Research methods and processes in an industry setting.
  • Experience in clinical strategy and study design in the area of liver disease and blood disorders including thrombocytopenia is strongly preferred.
  • A minimum of 8 years of clinical development experience is required.
  • Functional Technical Competencies required: Clinical Trial Design and Execution, Clinical Development Plan, Drug Development Plan and Regulatory management.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2798. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.