Chief Medical Officer - (relocation assistance provided) Top Pay - Job # 3010

Additional Information
  • Our Client offers an exceptional compensation package which will be commensurate on experience and great benefits.
  • For confidential consideration please submit a resume and salary history to claire@fullscalesolutions.com.
  • Please be sure to include the job number with your submission.
  • Full Scale Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
Client Synopsis:

Full Scale Solutions is currently recruiting for the following position located in Durham, NC.

Essential Duties and Responsibilities:

The Chief Medical Officer (CMO) reports to the Chief Executive Officer and is responsible for planning and executing the Company’s clinical development programs. This incumbent will supervise the Company’s clinical development team and will be responsible for program planning, clinical trial protocol development, and clinical trial execution working in coordination with the VP of Regulatory Affairs, VP Manufacturing, the Director of CMC and Quality.

Responsibilities will include, but are not limited to:

  • Development of clinical development program plan for new drug candidates, clinical protocol development, analysis of study data and preparation of clinical study reports.
  • Responsible for providing clinical leadership for both internal staff and for external partners in developing and executing clinical trial strategies for Company gene therapy drug development candidates.
  • Develop clinical strategies and implementation plans, in partnership with both internal and external resources to achieve the Company’s strategic and tactical goals/objectives.
  • Provide “hands on leadership” to the clinical team for the successful planning and execution of each clinical trial.
  • Planning and development of clinical development strategies for Phase I/II and pivotal II/III programs.
  • Assure that the Company’s clinical team fully adheres to Good Clinical Practice.
  • Work with clinical research associates, clinical pharmacologists, medical writers, statisticians, data management, members of multidisciplinary project teams and their managers to review and interpret data.
  • Contribute to the preparation of abstracts, presentations and manuscripts.
  • Work with clinical team and other resources to select trial investigators and clinical sites.
  • Ensure that appropriate resources are utilized to provide expert and timely support of clinical trials, including the selection and management of external entities (such as CROs and other vendors) and also identifying/hiring employees, contractors, etc.
  • Meet established timelines and budgets.
  • Attend clinical, scientific and investigator meetings representing the company as a medical expert regarding drug development candidates.

Requirements:

  • MD (neurology) with US medical license, clinical training and previous clinical trial leadership experience; board certification desirable - Prior experience with MS or gene therapy.
  • Must have knowledge of GCP, ICH and other regulatory requirements for evaluating and reporting adverse events, clinical trial data, clinical brochures and scientific publications.
  • Experience working with a CRO dealing with all study activities or at least site selection, monitoring and data management is required.
  • Experience in protocol development and design, including understanding of the strengths and weaknesses of study design.
  • Experience in the development of comprehensive clinical development programs.
  • Previous experience conducting clinical research involving drug development candidates for pharmaceutical / biopharmaceutical companies, global clinical trial experience would be ideal.
  • Experience leading clinical and cross functional teams.
  • Candidates need to be very hands on in this “roll-up the sleeves and get it done” Company.
  • Entrepreneurial, rapid paced company environment, highly focused and responsive to patients and clinical trials.
  • Demonstrated record of accomplishment in a compressed time frame.
  • Everything is about the patient – must have passion around the patient.
  • Very collaborative management team.
  • Strong sense of urgency and initiative.
  • Creative problem solving.
  • Excellent communication skills – presenting, listening and writing.
  • Motivation to work in a fast-paced, high accountability, small company environment.
  • A "get things done" professional who leads through influence and interpersonal skills.

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