Lead, Preclinical Development in Gene and Cell TherapiesPurpose & Scope The Preclinical Development Lead in Cell and Gene Therapies (CGT) will 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.
Role and 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 plays 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.
Required Qualifications - 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.
Preferred Qualifications - Cell therapy experience
- AAV gene therapy experience
- Ocular indications
Location and Working Environment- This position is based in Westborough, MA. This is a hybrid position with the expectation that the incumbent goes onsite at a minimum, 1-2 days a week. However, she/he should be able to be onsite more often as needed.
- At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver.
- Hybrid work from certain locations may be permitted in accordance with Astellas' Responsible Flexibility Guidelines.
Salary Range$145,460-207,800 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations.)
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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