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Chief Medical Officer

Cambridge, MA

Posted: 06/05/2019 Employment Type: Direct Hire Job Category: Clinical: Clinical Operations and Development Job Number: 2374

Our Cambridge, MA-based client is seeking a highly experienced and motivated individual to provide leadership and direction for their clinical development portfolio and organization. The Chief Medical Officer will be responsible for the strategy, direction and execution of the company’ s clinical development plans.  This role reports directly to the president and also serves as a member of the executive leadership team. The successful candidate will have over 15 years of experience in clinical development with a strong background in medical science, building and developing highly functional collaborative development organizations. This individual needs to be a strategic thinker with a track record of moving clinical projects successfully from early stage to pivotal trials in a timely fashion.  This individual will be driven to succeed within a hypothesis-driven, team-oriented, and multi-disciplinary biotech environment.

Principal Duties and Responsibilities:
  • Advancement of clinical programs
    • Provide strategic leadership and supervision of all clinical programs to successfully advance the company’ s clinical programs, including
      • Development and update of long term strategic plan adjusted by emerging new information.
      • Timely decision making.
      • Processes and interprets data from trials including outcomes and findings, leading to recommendations on clinical development and regulatory filing strategies.
      • Oversees the analysis and interpretation of clinical trial data and reporting of clinical trial results
      • Identification of project risks and contingency planning
    • Prioritize all clinical development activities, managing both internal and external resources to achieve company goals while ensuring adherence to timelines and budgets.
    • Oversees key clinical support activities
  • Building and leading clinical organization:
    • Provide leadership, strategic oversight, resource management, and organizational framework to ensure timely delivery of clinical programs.
    • Supervise and direct the efforts of all clinical development staff.
    • Identify, support, manage and develop talents; acting as a resource and mentor to team members— providing guidance, instruction, feedback and coaching.
    • Build a dynamic scientific and professional culture focused on productivity and innovation that reflects company values.
  • Leverages medical expertise to contribute to the development of the company’ s corporate strategy.
  • Provides clinical and scientific input to discovery and early development activities.
  • Proactively manage communication and build strong collaborative relationships with key stakeholders both internally and externally, including leading interactions with academic thought leaders, investigators, cooperative groups, and other clinical stakeholders.
  • Professionally represent the organization externally in advisory board, collaborations, partnership discussions, and conferences, board of directors.
  • Maintain high standard of compliance, patient safety, and data quality throughout the lifecycle of each project. Identify areas of best practice and process improvement.
  • In addition to leading and supervising the Clinical Research, the CMO will have direct line responsibility for Clinical Operations, Clinical Pharmacology, Safety, and Regulatory.

Requirements / Qualifications:
  • M.D with 15+ years of experience overall and 10 years in a pharmaceutical and/or biotechnology setting.
  • Demonstrated clinical leadership as evidenced by strong track record of driving multiple successful project advancements. 
  • Proven track record developing and managing R&D strategic and operating plans and budgets, as well as recruiting and managing a team in a biotech research environment
  • Demonstrable expertise relating to all aspects of the drug development process and the ability to identify and resolve complex issues related to programs.
  • Extensive working knowledge of oncology clinical landscape, regulatory guidance, and flexible resourcing models.
  • Successful track record in drafting and implementing clinical trial protocols required.
  • Demonstrated experience and capability to build strong external network of key opinion leaders.
  • Proven ability to manage timelines and resources to drive projects toward key decision criteria.
  • Extensive experience interfacing with, and providing scientific guidance to CRO partners and proven ability to work efficiently in a hybrid model.
  • Experience in interacting with relevant functions that are integral to successful clinical program advancements
  • Must have the demonstrated ability to recruit, motivate, and lead successful teams with a history of developing a culture of teamwork, collaboration, transparency, and effective communication.
  • Excellent written and oral communication skills.

Lisa Madden
EVP, Clinical Staffing

Lisa is an inspiring leader and mentor, driven by an inherent desire to help others and make a difference. An advocate for growth and professional development, Lisa brings 18 years of recruiting and business development experience to The Steely Group, and as Executive Vice President of Clinical Staffing, she oversees the direction and strategy of the Steely recruiting team.

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