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Senior Director, Endocrinology Clinical Development

Reference Number: 2797
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, Endocrinology Clinical Development.

The Senior Director, Endocrinology Clinical Development is responsible for leading and directing the International Project Team, providing much needed depth in this relatively new development space within Neuroscience & General Medicine and effectively contributing to the direction and support of the drug into the future.  The incumbent will demonstrate exceptionally strong leadership capability, proven strategic agility and will establish a multidisciplinary team to execute potential new indications, ensure the commercial success of the indication and completion of the FDA post marketing CVOT commitment, as well as support other compounds coming into focus in the General Medicine arena.

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 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 Resource Management.
  • 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 and department budget.
  • Reviews 3rd party (contractors, consultants and vendors) work product and deliverables to approve payment.
  • 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.
  • Actively partners with the Neuroscience & General Medicine Leadership Team to strategically focus and build-out the unit's expertise and market competitive position in the areas of metabolism and endocrinology.

We seek candidates with the following qualifications:

  • MD is required, MD/PhD preferred.
  • Scientific/Clinical Development experience in areas of endocrinology and metabolism.
  • An understanding of factors necessary for commercial success of medical products.
  • 8 years of related industry experience.
  • A proven track record of success in clinical development across all phases of development.
  • Demonstrated leadership experience.
  • Competencies must include: 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 2797. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.