Position: Senior Medical Director

Position: Senior Medical Director

Flatley Discovery Lab is an independent not-for-profit laboratory for Cystic Fibrosis drug discovery research and development. Our goal is to create patient value by accelerating the development of new treatments for CF. We are focused on discovering small molecules that help restore F508del-CFTR protein function.

This position reports into the Chief Executive Officer. The Senior Medical Director is responsible for developing the company’s global product portfolio strategy to bring products to market in compliance with global regulatory, legislative and medical/health requirements. The position has functional responsibility for all clinical development activities which may be from human proof of concept through approval.

Roles and Responsibilities

  • Ensure appropriate objectives and resources are deployed to meet strategic portfolio plans delivering on key milestones to advance all the company’s products in development
  • Develop strategic plans for the company’s product portfolio to ensure development programs meet quality and safety standards required by patients, health care providers, and regulatory agencies
  • Represent the Company with regulatory and legislative agencies, globally addressing the scientific and medical/health aspects of our product portfolio
  • Build and maintaining key opinion leader relationships consistent with development objectives and represent the company at scientific conferences and advisory boards
  • Ensure drug safety and surveillance activities are consistent with established regulations and internal SOPs to meet or exceed safety objectives
  • Provide expert opinion and due diligence research on business development opportunities
  • Have P&L and budgetary responsibility for clinical development and regulatory activities, providing strategic input to the annual and long-range budgetary process

Requirements

  • Medical degree in respiratory-related discipline highly preferred
  • Substantial clinical development and execution experience, handling multiple parallel programs
  • Current pharmaceutical industry experience, people management, project management and budget management experience required
  • Broad scientific, technical and regulatory understanding of most of the functions involved in the development of a pharmaceutical product
  • Possess excellent judgment and strong decision-making capabilities
  • Effective management, interpersonal, communication, negotiation, and problem-solving skills

Flatley Discovery Lab, LLC is an Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status

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