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Director, Clinical Data Science

Reference Number: 4289
Location: MA

Our client is a clinical-stage immuno-oncology company. They have asked us to assist them in their search for a Director, Clinical Data Science.

Major tasks and responsibilities will include:

  • Develops and/or leverages tools for long term, scalable, practical solutions for medical, clinical and translational data integration, review and visualization supporting the company’s clinical portfolio.
  • Delivers program level information strategies and services for optimal use and reuse of internal and external information that will advance research, development, and commercialization of the company’s portfolio.
  • Serves as the key technical clinical data integration expert.
  • Defines and drives the data integration strategy and standards for the company.
  • Ensures oversight of work carried out by or on behalf of Clinical Data Science in accordance with applicable SOPs, regulations and working practices.
  • Works with internal colleagues to design and execute data analysis plans, and to summarize the actionable findings to support both exploratory research and Biologics License Applications.
  • Develops and validates the analysis workflow, software applications, and data warehouse to improve visualization, integration, and accessibility of complex clinical data.
  • Designs, develops, and implements methods, processes and systems to consolidate and analyze diverse data sets including structured and unstructured.
  • Develops or oversees software programs, algorithms, dashboards, information tools, and queries to clean, model, integrate and evaluate datasets.
  • Keeps abreast of new analytic methodologies and technologies.
  • Collaborates with functional business units to drive business solutions and direction.
  • Contributes to review and development of clinical data collection tools, both CRF and non-CRFs using and electronic data capture (EDC) system and/or other data collection systems.
  • Executes clinical study data due diligence for acquisition/in-licensing and co-development deals, as well as clinical research collaborations as required.
  • Collaborates with the Vice President, Clinical Development Operations to plan, build and lead the Clinical Data Science organization.

We seek candidates with the following qualifications:

  • Degree in computer science or related technical discipline required.
  • Must have a minimum of 10+ years of relevant experience
  • Requires a minimum of 2+ years working in biotech environment.
  • Experience in oncology therapeutic areas required.
  • Must be able to demonstrate understanding of clinical research, the drug development process, GCP, CDISC (SDTM, CDASH, ADaM, & SEND) requirements and related regulatory guidelines.
  • Requires strong verbal and written communication skills.
  • Prior experience in successful implementation utilizing and leveraging outsourcing strategies required.
  • Must have experience using EDC products (Medidata RAVE preferred) and data visualization tools (e.g. Spotfire, jReview).
  • Requires experience evaluating, implementing and managing infrastructure (storage/compute/networking), enterprise systems, and core services.

If interested, please email your resume as a Word attachment to us, reference 4289.  No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.