Clinical Development

Medical Director or Senior Medical Director

North Carolina, U.S. (Hybrid)

Primary Job Responsibilities
Specific tasks/projects, skills, short and long-term objectives, management responsibilities, if any

  • Provide medical leadership and input to the Company’s clinical development function and clinical trial activities, including:
    • clinical trial development and execution of plans
    • assessment of safety parameters of enrolled subjects, including serious adverse events and relevant adverse events
    • advise on study-related medical questions and problems
    • analysis, interpretation and reporting of clinical study results to prepare documentation required for regulatory submissions and approvals
    • ensure ethical conduct of clinical programs
  • Development of clinical protocols to support the company’s product strategy, data collection and management and final reports developed in compliance with appropriate standard operating procedures, regulatory, and medical standards
  • Direct the identification and use of clinical consultants as required
  • Responsible for KOL development, establishing relationships and communications with KOLs and investigators worldwide
  • Monitor changes in the regulatory/medical environment which may impact the global drug development process
  • Manage the development, finalization and submission of abstracts, scientific presentations, and publications
  • Provide clinical expertise and input to drug discovery, business development and commercial efforts
  • Represent Clinical in communications with Regulatory Agencies, Corporate executive management, Corporate partners and in public meetings
  • Provide clinical input to Business Development for partnering discussions and due diligence activities, and to the pre-clinical team for drug mechanism studies as needed

Job and Level Requirements
Minimum education and experience required, also ideal but not required qualifications

  • MD/DO Degree; preferred Board Certification in Oncology
  • At least 5 years of drug development experience; preferably in industry
  • Excellent understanding of pharmaceutical processes and GxP requirements, including broad and solid understanding of functional areas of drug development, including but not limited to, preclinical, clinical operations, regulatory, pharmacovigilance, drug supply, and biometrics (including biostatistics and data management)
  • Track record of excellence in the strategic development of oncology drugs, including the design and management of clinical development plans for new molecular entities and new indications for established products, reflecting a commitment to goals and delivery of results within planned timeframes and budgets
  • Established relationships/connections with Key Opinion Leaders
  • ‪Candidates must possess highly effective communication skills and be fluent in the English language, both written and verbal
  • The candidate should be detail-oriented, a self- starter and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment.

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