Prothena

Director/Sr. Director, Clinical Development

US-CA-South San Francisco
Job ID
2017-1187
Category
Research & Development

Overview

The Director/Sr. Director of Clinical Development will report directly to the VP of Clinical Development and will be responsible for implementing and directing the clinical strategy of the development programs.  The successful candidate will possess a solid understanding of US and international regulations and the drug approval process. A clear understanding of translational medicine is required, including but not limited to, basic pharmacokinetics/pharmacodynamics principles, the use of biomarkers, and data interpretation as they apply to drug development.  This role will manage the design and execution of clinical studies, oversight and interpretation of clinical trial data and clinical interactions with cross-functional groups across the organization.  This role will also include external interactions with regulatory authorities, key opinion leaders (KOL), scientific and academic collaborators, patient advocacy organizations, and other external stakeholders.  

Responsibilities

  • Lead and oversee the design and execution of all clinical studies
  • Formulate clinical development plans - ensure integration of clinical plan and strategy with the needs of other stake holders (e.g., Regulatory Affairs, Medical Affairs, Commercial, etc.)
  • Provide clinical and scientific input during development, execution and completion of clinical trials
  • Partner closely with other functional areas within R&D (pharmacology, preclinical, translational medicine, statistics, safety, etc.) and external investigators and consultants (KOL, scientific advisory board) and vendors to facilitate the execution of clinical trials and programs
  • Interpret clinical trial data and take a major role in the preparation of reports, regulatory submissions and publications
  • Identify, interact and build collaborative relationships with KOLs and academic organizations to assure incorporation of latest methods and guidelines into clinical development plans
  • Oversee clinical advisory board meetings to obtain strategic input into clinical program development
  • Prepare and present study status and strategy to management
  • Serve as lead medical representative with regulatory agencies

Qualifications

  • MD required with 10+ years of pharmaceutical development or other relevant experience required
  • Thorough knowledge of GCP and ICH guidelines for clinical research and regulatory submissions (NDAs and/or BLAs, INDs), and other regulatory documents (CSRs, IB and clinical study protocols) required
  • Demonstrated ability to manage and/or work on cross-functional teams
  • Success in working with and influencing key external stakeholders (i.e. KOLs, investigators) including presenting and responding to FDA and other regulatory authorities
  • Solid understanding and experience with US and International regulatory authorities and the drug approval process
  • Experience in rare diseases is desirable, but not required
  • Travel – approximate 15%

Competencies and Attributes:

  • Demonstrated leadership to drive results that are needed to achieve company objectives in accord with Prothena’s culture and core values – courageousness, creativity, selflessness and humor
  • Collaborative with excellent organizational and time management skills
  • Strong attention to detail and ability to work effectively with cross functional teams in leading complex programs and successfully leverage internal and external partnerships
  • Outstanding leadership skills and ability to problem solve
  • Excellent strategic planning, written and oral communication skills

 

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed