Senior Director, Research

Location
94608, Emeryville
Posted
Apr 26, 2018
Required Education
Doctorate/PHD/MD
Position Type
Full time

The canditate will lead a team of scientists to conduct nonclinical efficacy and safety studies in support of Adamas’ neurological diseases projects. In this capacity, the candidate will develop nonclinical strategies and oversee the design, execution, analysis, and reporting of the research components of discovery and development programs. The successful candidate will possess the relevant background and experience in neuroscience, and possess appropriate leadership skills, in order to effectively execute program objectives.  The candidate will be based in Emeryville, CA and will report to the Vice President, Research. 

Responsibilities:

  • Manage day to day activities in research and development, with direct responsibility for meeting program timelines and budgets
  • Formulate nonclinical strategies in support of multiple CNS-related projects
  • Assume ownership of nonclinical activities in support of projects and drive activities to completion with minimal supervision
  • Develop and manage nonclinical efficacy and safety studies
    • Contribute to the design, execution, data analysis, and writing of study reports for nonclinical studies
    • Identify, evaluate, and manage external collaborations and CROs
    • Closely interact with CROs to monitor the execution of GLP and non-GLP studies
  • Contribute to the writing of non-clinical sections for project development plans
  • Contribute to the conceptualization and writing of research publications
  • Review and interpret scientific literature to guide program objectives
  • Prepare and edit nonclinical components of documents for regulatory submission (e.g. INDs, investigator brochures, NDAs, and briefing documents)
  • Contribute to strategic development for life-cycle extension of existing Adamas products and for evaluating new product opportunities
  • Represent Research on project teams
  • Interact very closely with the following functions to ensure consistency of development strategies:
    • Clinical Research
    • Medical Affairs
    • Pharmaceutical Development
    • Regulatory
    • Commercial
    • Intellectual Property
  • Identify goals and priorities that support short- and long-term program strategies
  • Ensures compliance with corporate policies and procedures, as well as, US healthcare laws and regulations

Qualifications:

  • PhD, DVM, or equivalent degree in neuroscience, pharmacology, pharmaceutical sciences, or related discipline
  • 10+ years experience in a drug development environment within biopharmaceutical industry
  • Leadership experience managing projects and internal and external personnel
  • Strong research background in neuroscience, with extensive knowledge of neurodegenerative and/or psychiatric diseases, as demonstrated by publication record
  • Experience writing and contributing to regulatory submissions
  • Strong quantitative and analytical skills
  • Ability to prioritize and drive results with high scientific rigor
  • Excellent verbal and written communication skills
  • Thorough knowledge of FDA and ICH guidance documents including GLP regulations prefered
  • Experience with IND/NDA-enabling toxicology studies preferred
  • Successful experience in fast-paced entrepreneurial environment
  • Fit with Adamas culture and values