Director, Clinical Research and Medical Affairs

Remote
4951
Our client is a clinical-stage biotechnology company. They have asked us to assist them in a search for a Director, Clinical Research and Medical Affairs.  

Major tasks and responsibilities include:
  • Provides leadership that integrates clinical science, ophthalmology, and input from the medical community.
  • Integrates the scientific rationale, regulatory requirements, and commercial goals to build a solid strategic framework for the current and upcoming clinical trials.
  • Develops innovative study designs, and designs and drafts documents required to conduct clinical trials.
  • Analyzes and interprets clinical trial data, including the strengths and weaknesses of study design and the applications of results to standard of care and clinical practice.
  • Provides input and guidance on scientific and clinical issues.
  • Supports the design and development of data collection systems for all ongoing trials, including identifying key data for eCRF collection and data analyses.
  • Reviews medical and clinical data to support patient eligibility decisions.
  • Interprets, develops, and prepares medical and scientific data for presentations and study milestones.
  • Provides scientific oversight and cleaning/querying of key efficacy data for ongoing clinical trials throughout conduct.
  • Serves as a key point of contact for the clinical operations personnel, clinical trial sites and CROs for clinical science questions.
  • Assists clinical operations personnel to manage all clinical aspects of assigned clinical studies.
  • Authors pertinent clinical sections of regulatory filings.
  • Supports the Vice President, Clinical Research in the publication planning and execution process.
  • Assists the Clinical Research Scientist, clinical operations personnel, and data management groups in working with external vendors to ensure that appropriate data is collected.
  • Provides clinical support to cross-functional departments as needed.
  • Assists in the development and maintenance of clinical SOPs related to GCP activities.
  • Assists the Safety & Pharmacovigilance team with the design and execution of the Safety Management Plan.
  • Has extensive knowledge of the pharmaceutical/biotech industry and FDA IND, and ICH, regulations. Maintains active involvement in biotechnology and clinical affairs organizations to ensure up-to-date knowledge of current and future industry trends.
 
We seek candidates with the following qualifications:
  • An advanced degree is required (PharmD, PhD, or MD).
  • At least 5 years of relevant scientific, clinical, or drug development experience is required.
  • Must have at least 2 years of progressive responsibilities in drug development and a proven track record for clinical and scientific leadership in drug development.
  • Requires the ability to lead directly and by influence, including strong problem solving, conflict resolution, and analytical skills.
  • The ability to synthesize and interpret complex information is required.
  • Must have high level of integrity, autonomy, and motivation.
  • Must be quality focused and well-organized.
  • Excellent written and verbal communication skills are required.
  • Must demonstrate leadership and team building skills as well as the ability to perform effectively in a dynamic environment.
  • Must demonstrate strategic and critical thinking.
  • Experience working with biotechnology products preferred and previous experience in ophthalmology clinical trials is preferred.
  • In-depth understanding of GCP and FDA IND regulations are required.
  • Must have a working knowledge of Microsoft Word and Excel.
 
If interested, please apply directly to this job posting. No calls 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 and Forbes' list of Top 200 Best Executive Recruiting Firms.
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