Chief Medical Officer - Job # 3138

Additional Information
  • Our Client offers an exceptional compensation package which will be commensurate upon experience, a great culture and benefit package.
  • 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 Raleigh-Durham, NC.

Essential Duties and Responsibilities:

We are seeking to hire a Chief Medical Offer (CMO) based in Raleigh - Durham, NC. This incumbent will be responsible for planning and executing the Company’s clinical development programs, supervising the Company’s clinical development team as well as program planning, clinical trial protocol development, and clinical trial execution. S/he will report to the CEO and work in close coordination with the Head of Regulatory Affairs, Head of Manufacturing and Head of CMC and Quality.

Duties include, but are not limited to:

  • The creation of the clinical development program plan for early stage, orphan disease and 505(b)2 candidates.
  • Clinical protocol development, analysis of study data, and preparation of clinical study reports.
  • Provide clinical leadership for both internal staff and for external partners in developing and executing clinical trial strategies for the Company.
  • Develop clinical strategies and implementation plans, in partnership with both internal and external resources to achieve the Company’s strategic and tactical goals/objectives and provide “hands on leadership” to the clinical team for the successful planning and execution of each clinical trial.
  • Plan and develop clinical development strategies for Phase I/II and pivotal II/III programs and ensure that the Company’s clinical team fully adheres to Good Clinical Practice.
  • Work with CRA's, 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.

Qualifications:

  • MD (preferred experience in pediatrics with overlap in psychiatry and neurology) with US medical license, clinical training and previous clinical trial leadership experience; board certification desirable.
  • 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 which include - site selection, monitoring, budgeting and data management.
  • 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 is helpful though not imperative.
  • Experience leading clinical and cross functional teams.
  • Candidates need to be very hands on in this “roll-up your sleeves and get it done” Company. Sense of urgency and initiative are critical success factors.
  • Entrepreneurial, rapid paced company environment, highly focused and responsive to patients and clinical trials.
  • Demonstrated record of accomplishment in a compressed time frame.
  • Creative problem solving.
  • Excellent communication skills – presenting, listening and writing.
  • Motivation to work in a fast-paced, high accountability, small company environment.
  • A driven attitude and collegial professional who leads through influence and interpersonal skills.

© 2002-2018 Full Scale Solutions. All Rights Reserved.