Vice President / Head of Clinical Development

Lead clinical development activities for assigned clinical program(s) within a matrix environment and provide subject matter expertise and direction to the development and operations of assigned clinical project(s). 

Reporting Line:  Chief Medical Officer

Responsibilities

  • Apply knowledge of clinical development and project management to guide the creation of an overall product development plan for assigned clinical asset/s
  • Establish clear project plans and budget/s, and lead and manage the day to day clinical development activities and resources to efficiently achieve critical clinical development milestones
  • Work with clinical investigators, external medical advisors and subject matter experts to evaluate clinical trial designs/development options and institute path forward to ensure achievement of program objectives  
  • Provide direct managerial oversight and execution of clinical trials
  • Identify and effectively leverage internal and external capabilities needed to advance clinical milestone activities.
  • Ensure proper oversight of medical monitoring activities for clinical trials and respond to investigator questions concerning clinical trial conduct
  • Interpret clinical trial data, and work with the project team/s and investigators to develop scientific conclusions from clinical trial data
  • Contribute to the writing review and editing of study-related documents including clinical trial protocols, clinical study reports, regulatory documents, presentations and manuscripts for assigned clinical programs
  • As senior medical/clinical lead directly contribute to the NDA submission pathway and support filing activities as needed
  • Serve as the senior medical lead on interactions with regulatory authorities
  • Represent the Company at medical/scientific meetings and congresses pertaining to areas of direct responsibility
  • Prepare and deliver program updates
  • Establish collaborative and productive relationships with parent company, internal/external partners and relevant affiliates.
  • Perform other duties as requested by the senior management

Qualifications

  • M.D.  with thorough understanding of the oncology arena 
  • 10 + years of industry experience in clinical drug or program development or equivalent academic experience in clinical trials, especially in phase 1, 2 and 3.
  • Demonstrated skills working within a matrix environment
  • Ability to work collaboratively with others within and external to the company
  • Expert level expertise in the design and conduct of clinical trials and project management in relevant therapeutic areas
  • Experience evaluating outcomes of clinical trials and basic knowledge of clinical trial outcome standards
  • Ability to evaluate complex clinical development options and propose solutions
  • Ability to apply productive program management expertise to drive milestone achievement

Job Location: Cambridge, MA

Please send resumes to talentacquisition@bostonbiomedical.com