Lead, Preclinical Development in Gene and Cell Therapies
About The Position
The primary purpose of the Preclinical Development Lead in Cell and Gene Therapies (CGT) will be to play a leading role in developing and executing the nonclinical strategy in support of Astellas CGT programs. The successful candidate will directly influence the discovery and development of cell and AAV-based gene therapies by designing, overseeing, and interpreting in vivo and in vitro studies. The incumbent will be the primary driver of Research Program Teams spanning discovery through IND/CTA submissions. This is a hybrid role that has no laboratory responsibilities. In addition, the Preclinical lead will draft nonclinical sections of regulatory submission documents. The successful candidate will partner with other scientists, clinicians, and external experts to advance transformational treatments for patients with severe diseases.
Requirements
- PhD in a relevant life-science discipline with 9+ years of pharmaceutical or biotechnology industry experience.
- Demonstrated experience working with animal and in vitro models, and the ability to design experiments aimed at predicting clinical outcomes.
- Strong understanding of molecular biology techniques such as PCR, hybridization and blotting methods, immunoassays, NGS, etc.
- Substantive experience working with biologics, preferably cell and gene therapies.
- Excellent critical thinking and scientific skills, and a demonstrated ability to analyze, interpret, and clearly communicate, with transparency, complex results.
- Deep understanding of regulatory guidance in preparation for IND/CTAs.
- Proven ability to work effectively and collaboratively on cross-functional teams, including leading and spearheading projects internally and externally.
- Excellent oral and written communication skills
- Comfortable implementing and overseeing Good Laboratory Practices.
- Excited to work in a dynamic, fast-paced environment.
Nice To Haves
- Cell therapy experience
- AAV gene therapy experience
- Ocular indications
Responsibilities
- This position will be responsible for designing and establishing the in vivo efficacy and safety of Astellas CGT drug candidates from discovery stages through clinical development.
- Designs and oversees the execution of non-GLP and GLP studies with Contract Research Organizations, expert consultants, and academic laboratories.
- Analyze, interpret, and summarize nonclinical data. These data will be presented to internal project and senior management teams, and to global health authorities.
- Writes, edits, and finalizes nonclinical sections of regulatory documents and play a key role in interactions with global health authorities.
- Provides scientific and strategic leadership as a member and/or leader of Research Project Teams.
- Maintains a current understanding of pharmacology, toxicology, cell therapy, gene therapy literature and methodologies, as well as the scientific literature related to the specific indications being supported.
- Presents results at scientific conferences and drafts manuscripts for publication at peer-reviewed journals.
- Performs additional duties as needed in a fast-paced matrix organization.
Benefits
- Medical, Dental and Vision Insurance
- Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
- 401(k) match and annual company contribution
- Company paid life insurance
- Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
- Long Term Incentive Plan for eligible positions
- Company fleet vehicle for eligible positions
- Referral bonus program
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
Number of Employees
5,001-10,000 employees
