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Senior Director, Liver Clinical Development

Reference Number: 2799
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, Liver Clinical Development.

The Senior Director, Liver Clinical Development is responsible for providing clinical expertise/leadership and overall medical support to the clinical development of various compounds within the general medicine area.  The qualified candidate will also partner with the designated IPTL and clinical lead in the ongoing development of a drug in the acute liver indication.  This project is currently in Phase 3 with 2 ongoing clinical trials.  The incumbent will be primarily responsible for clinical development of immunologic and other select general medicine compounds already in or expected to initiate early phase clinical studies in the near future.

Major tasks and responsibilities will include: 

  • Directs and implements clinical research plans and programs according to established design principles.
  • Directs the integration of the Clinical Development and Drug Development Plan.
  • Leads the development of Clinical Protocols to meet the CDP objectives.
  • Serves as Study Director and drives the execution of the study from protocol concept to final report including interpretation of clinical data.
  • Serves as Medical Monitor and possibly Study Director for a study or clinical program, reviews and monitors study safety data.
  • Implements strategies to identify, monitor and resolve clinical program/trial issues.
  • Serves as SME to provide direction to all project team functions, organizes Advisory Board meetings (e.g., agenda setting), and identifies and liaises with KOLs regarding program strategy and scientific advice.
  • Interprets study data and develops integrated summaries of safety and efficacy.
  • Contributes clinical expertise and content to regulatory documents (e.g. briefing books, NDAs etc.)
  • May represent Clinical in discussions with Health Authorities.
  • Manages new tools and resources (tools, systems, vendors, etc.) while minimizing their costs to the organization.
  • Sets key deadlines and project milestones for projects within the function.
  • Manages contractors and ensures that contractors, consultants and vendors complete assigned work according to agreed timelines.
  • Makes appropriate budgetary allocations to targeted opportunities.
  • Evaluates appropriateness of requests for increased budgets.
  • Directs the use of financial standards across work teams for consistent level of compliance.
  • Reviews 3rd party (contractors, consultants and vendors) work product and deliverables to approve payment of invoices and resolves discrepancies.
  • Leads by example to encourages others to prioritize personal and professional development.
  • Acts as a coach and mentor to staff members across units.
  • Participates in recruitment, selection, performance, succession, and transition activities.
  • Identifies team training needs and recommends solutions.
  • Manages individual contributors and/or matrixed team members and may manage people managers both locally and remotely.
  • Manages all employee-related activities throughout the year, including performance management and development, compensation planning (may be responsible for), internal talent assessment and succession planning as well as recruitment and selection.
  • 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.
  • An Immunologist or an MD with extensive experience in development of products for immune system related disorders is strongly preferred.
  • At least 6 years of related clinical development industry experience.
  • Extensive experience in Clinical Research methods and processes in industry setting.
  • Functional/Technical Competencies required: Clinical Trial Design, 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 2799. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.