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Medical Director

2 months ago

Cambridge, Massachusetts, United States ONO PHARMA USA Full time
Job Summary

ONO PHARMA USA is seeking a highly skilled Medical Director to lead our Clinical Development team. As a key member of our organization, you will be responsible for providing strategic oversight for clinical development programs and associated clinical trials.

Key Responsibilities
  • Program Oversight
    • Ensure the highest medical integrity and conduct of clinical studies in the execution and completion of the clinical and regulatory components of the program.
    • Enhance and streamline programs in the Clinical Development organization.
    • Develop proactive strategies to prevent risk and promote safety of patients enrolled in investigational trials.
  • Planning and Execution
    • Ensure the highest medical integrity and conduct of clinical studies in the execution and completion of the clinical and regulatory components of the program.
    • Ensure medical consistency of clinical data for submission to regulatory organizations.
    • Oversee the safety profile of a portfolio of investigational drugs in accordance with corporate policies and legal regulations.
  • Financial Outcome
    • Ensure consistency of coded terms for adverse events and develop strategies to avoid failures to identify harm.
    • Collaborate with cross-functional teams to evaluate product candidates and determine production indication.
  • Operation and Improvement
    • Enhance and streamline programs in the Clinical Development organization.
    • Identify potential study risks and implement solutions to avoid delays to the clinical study execution.
    • Ensure all clinical development plans, protocols, reports, publications, and regulatory documents are of the highest quality and scientific, operational, and ethical standards, in compliance with external regulations, and completed on time.
  • Innovation
    • Develop proactive strategies to prevent risk and promote safety of patients enrolled in investigational trials.
  • Talent Development and Organization Growth
    • Facilitate continuous learning and knowledge transfer throughout the duration of the project, as well as upon its completion.
  • External/Internal Relationship
    • Collaborate cross-functionally to achieve organizational alignment and collective decision-making on approach and achievement of corporate objectives.
    • Represent the organization at high-level external meetings.
Requirements
  • Education
    • Medical Degree (M.D.), possessing medical expertise in the therapeutic area of oncology or non-oncology is required.
  • Experience
    • 5 to 7 years of in-depth knowledge and clinical development experience within the pharmaceutical or biotechnology industry, or 7 to 9 years clinical trial experience in an academic setting, collaborating with pharmaceutical sponsors.
    • Experience as a Clinical Development Medical Monitor providing clinical leadership, strategic medical input, and medical evaluation of safety data for all clinical deliverables.
    • Experience working with regulatory bodies and creating scientific methodology for unbiased and well-controlled experimental design, methodology, analysis, interpretation, and reporting of study results.
  • Skills and Abilities
    • Possesses a thorough knowledge and understanding of clinical development in various therapeutic areas, the impact of pharmacologic agents on humans, nonclinical (toxicology) and regulatory requirements for testing new therapies in humans.
    • Possesses proficiency with pharmacovigilance programs including signal detection and safety supportive of drug safety and Medical Dictionary for Regulatory Activities (MedDRA).
  • Language/Interpersonal Skills
    • Excellent communication and presentation skills.
    • Ability to effectively present technical information across the organization.
  • Working Conditions
    • Work is generally sedentary in nature, but may require standing, walking, grasping, and lifting/moving up to 15 pounds.
    • The noise level in the work environment is usually quiet.
    • This role requires the incumbent to travel up to 30% of the time.