VP/SVP – Clinical Development (Rare Genetic Diseases)

VP/SVP -Clinical Development (Rare Genetic Diseases)

Boston or Cambridge, MA

The VP/SVP Clinical Development (Rare Genetic Diseases) will be responsible for all clinical development and regulatory strategy and execution and will be tasked with advancing novel medicines through clinical trials.

 

Additional responsibilities required include:

  • Drive strategy and execution of clinical and regulatory development activities from pre-IND through clinical development
  • Directly supervise clinical operations, clinical research, data management and analysis, regulatory and medical affairs, and support related hiring strategy and decisions
  • Supervise development of patient registry and / or natural history studies
  • Manage the analysis, interpretation and reporting of clinical trial data and results
  • Work with internal and external parties to develop target product profiles and translate these product profiles into clinical development
  • Provide strategic input supporting prioritization of preclinical programs, in collaboration with Chief Science Officer
  • Collaborate with Chief Science Officer to move discovery / preclinical product candidates into clinical investigations / development
  • Help establish Company culture in a manner consistent with the company’s values
  • Communicate on behalf of the Company with key opinion leaders and patient communities at conferences and other external events, and also with investors, in a manner supportive of the Company’s objectives
  • Represent the Company with regulatory and legislative agencies
  • Develop and manage clinical and regulatory budget

Qualifications

Education and Experience:

  • MD / PhD
  • Minimum of 10 years relevant experience in all aspects of designing and executing clinical trials, including early clinical / translational development and mid to late stage clinical development and execution
  • Experience in managing clinical operations, regulatory affairs and medical affairs groups

Knowledge and abilities:

  • Expert knowledge of rare disease clinical trial design and analysis
  • Deep scientific, technical, and regulatory understanding of drug development
  • Budget management and project management experience
  • Team player with executive demeanor, strong judgement, and decision-making capabilities
  • Outstanding management, interpersonal, communication, negotiation, and problem-solving skills
  • Highly motivated individual who can accommodate the demands of a rapidly growing biotechnology company

Additional information

  • Position is located in Boston, Massachusetts and will require up to 25% travel

Interested candidates should email CV to tsharon@tseworldwide.com