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


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


Michael is a 1996 graduate from Rutgers, The State University of NJ where he majored in Political Science. After Rutgers, Michael spent a year in Israel studying and working with early stage tech companies. After returning to the US, Michael spent 5 years with The Princeton Review in Operations of their graduate level courses. In 2001, Michael joined a staffing company where he led his office in sales of IT consulting services. In 2003, Michael started TSE and quickly found a niche in Strategy Consulting. He has formed partnerships with some of the leading consultancies in the areas of portfolio strategy, commercial assessment, market assess, payer strategy and operational effectiveness. Michael has helped consultancies and client side companies make key hires. In addition to recruiting, Michael helped Rutgers University create their Center for Innovative Ventures of Emerging Technologies and served as an Entrepreneur-in-Residence and Sounding Board Member for 5 years. He continues to stay active in the field of higher learning helping students of the sciences think about careers in the pharmaceutical industry.