CSO – Head of Discovery – Rare Disease

CSO – Head of R&D – Rare Disease,  San Francisco or Palo Alto, CA

Job Description

The Chief Scientific Officer (CSO) will lead our research programs from hypotheses to clinical trials. The CSO will lead all preclinical activities (discovery, development, etc.)

Responsibilities

Preclinical

  • Evaluate current therapeutic avenues under investigation  and conceive of additional options to pursue, then contribute to program selection
  • Establish clear expectations and priorities and drive key initiatives to completion
  • Guide preclinical R&D for multiple programs
    • Plan research activities so they enable Investigational New Drug (IND) submission
    • Work with internal members and outside contractors to prepare research protocols
    • Analyze and interpret data, then advise on follow-up studies
  • Oversee preparation and submission of patent applications

Clinical ( We plan to hire a physician – CMO when we reach the clinic)

  • Lead IND through NDA (New Drug Application) submission processes
  • Interact with regulatory authorities and advisors to facilitate safe and rapid translation of preclinical research to clinical trials
  • Design clinical research study protocols, including objectives, patient inclusion/exclusion criteria, dose selection, endpoints, sample size, and safety monitoring
  • Interpret results from clinical trials and guide future trials
  • Maintain knowledge of treatment landscapes including current treatment strategies, current and potential competitors, and new therapeutic developments

Requirements

  • MD, PharmD or PhD in the life sciences with at least 10 years of pharmaceutical or biotechnology industry experience in clinical drug development
  • Comprehensive understanding of the drug development process in all phases of testing
  • Strong scientific background, exemplified by publications and overall stature in the pharmaceutical/biotechnology industry
  • History of leading teams from discovery to clinical stages
  • Extensive experience designing, running, and managing multiple pre-clinical programs simultaneously
  • Track record of successful IND submissions and experience interfacing with regulatory agencies
  • Significant experience in designing and carrying out clinical trials
  • Experience in drafting patent applications and moving them through to issuance
  • Ability to consider new information outside of his/her area of expertise
  • Excellent communication, organizational, and interpersonal skills

Not required, but desired

  • Experience in gene therapy, enzyme replacement therapy, or gene editing
  • Experience in developing treatments for rare diseases and/or neurodegeneration

 

To see more about this opportunity – please read the following paper:

acscentsci.7b00224 2

Please email CV and Cover Letter to jobs@tseworldwide.com