The Chief Medical Officer provides direction and leadership for the clinical development pipeline programs in cell and gene therapy drug development and is responsible for the strategy, direction and execution of the company’s clinical development plans. This key role as a member of the senior leadership team determines and oversees research and drug development and sets the overall strategic direction of the company. A very unique opportunity to be a major contributor to the success of a well-positioned, stable, growth oriented biotech company.

 

 

  • Plan and develop the clinical development strategies for Phase I-IV programs
  • 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 entire R&D team, including but not limited to clinical, regulatory, research, etc. for the successful planning and execution of each clinical trial
  • Support all clinical aspects of implementing and overseeing all relative clinical studies for drug development
  • Manage activities of the CRO in conjunction with other members of the team
  • 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 CRO’s and other vendors)
  • Attend clinical, scientific and investigator meetings representing the company as a medical expert regarding drug development candidates
  • Oversees the portfolio management activities for the company to ensure appropriate objectives and resources are deployed to meet strategic portfolio plans delivering on key milestones to advance all of the company’s products in development
  • Is responsible for representing the company with regulatory and legislative agencies, addressing the scientific and medical/health aspects of the company’s product portfolio.
  • Provides guidance on health-related matters to leaders across the company and with outside health/medical and regulatory organizations
  • Works closely with corporate Business Development to search and evaluate new opportunities within the biotech/pharma industry

 

  • Medical degree, either a M.D., or a D.O
  • Board certified in a specialty
  • Advanced degree in management, M.S, M.B.A., etc
  • Valid medical license
  • 8-10+ years clinical development programs and cell and gene drug development
  • 3+ years of experience working with and understanding the clinical requirements of the Centers for Biologics Evaluation and Research (CBER)
  • Up to 5 years experience working in a team environment with 3 years in a supervisory position managing direct reports
  • 2-3 years of experience managing budgets
  • Supervisory experience desired
  • Excellent written, presentation and verbal communication skills

Salary:

up to $375K+ plus 40-50% Annual Bonus + stock options/LTI

Location:

REMOTELY-BASED preferably in PA/NJ/NY/CT Area

Relocation:

No, not at this time.

Code:

TE - 114