Pre-Clinical Research Lead
Our client is a biotechnology company. They have asked us to assist them in a search for a Pre-Clinical Research Lead.
Major tasks and responsibilities include:
- Directs candidate development from early discovery and proof-of-concept through IND enabling studies for specific programs.
- Provides leadership within a group of scientists and research associates.
- Oversees joint programs with external collaborators.
- Establishes and manages project timelines.
- Trains and develops staff at varying levels of experience.
- Writes and reviews documents to support regulatory filings, manuscripts, and presents results at appropriate scientific meetings.
- Targets validation and leads optimization by using a combination of different techniques.
- Develops strategies to support liver-specific delivery and transgene expression of our gene therapies in laboratory animals.
- Delivers rigorous, interpretable and scientifically sound IND enabling studies to facilitate product development.
We seek candidates with the following qualifications:
- Ensures departmental goals and objectives are met and aligned to the broader organizational goals and objectives.
- Prepares sample analysis reports and writes parts of regulatory submissions to regulatory agencies.
- A PhD in a relevant scientific discipline (ex. cell and molecular biology, biochemistry, etc.) is required.
- Must have 5+ years of hands-on experience in the field of gene therapy or a relevant field of expertise.
- Must have familiarity with IND enabling studies, regulatory filings, and GLP studies.
- Familiarity in AAV gene therapy or in key therapeutic areas, such as hematology or metabolic disorders is preferred.
- Previous management or supervisory experience is a plus.
- Experience managing external collaborations is preferred.
- Must have hands-on research experience, preferably with gene therapies targeting the liver.
- Strong organizational skills are required.
- Requires experience with studies in laboratory animals.
- Must have excellent communication skills both oral and written.
- Strong analytical skills and problem-solving capabilities are required.
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.