Lead, Preclinical Development in Gene and Cell Therapies

Astellas Pharma, Inc.; Westborough (MA); Hybrid; USD 145,000 - 208,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) match

Bonus eligibility

Long-term incentive plan

Company fleet vehicle

Job summary

Astellas Pharma, Inc. in Westborough, MA is seeking a Lead, Preclinical Development in Gene and Cell Therapies to drive nonclinical strategy for CGT programs, overseeing in vivo and in vitro studies and drafting nonclinical sections for regulatory submissions.

The role requires a PhD with 9+ years in biotech/pharma, strong GLP knowledge, and demonstrated cross-functional leadership to advance cell and AAV-based therapies toward IND/CTA readiness in a hybrid work setting.

Qualifications

• PhD with 9+ years in pharma/biotech; strong nonclinical background.
• Experience with animal and in vitro models to predict clinical outcomes.
• Regulatory familiarity for IND/CTAs and GLP guidance.
• Proven cross-functional leadership and project management.
• Excellent written and oral communication skills.

Responsibilities

• Design and establish in vivo efficacy and safety for CGT candidates.
• Oversee non-GLP and GLP studies with CROs and labs.
• Analyze and summarize nonclinical data for REG authorities.
• Draft nonclinical sections of regulatory submissions.
• Lead Research Project Teams and collaborate across functions.
• Maintain up-to-date knowledge in pharmacology, toxicology, and gene/cell therapies.

Skills

Scientific leadership

Molecular biology techniques

In vivo/in vitro models

IND/CTA regulatory knowledge

Cross-functional teamwork

Communication skills

GLP compliance

Education

PhD in life-science

Tools

PCR

NGS

Blotting

Hybridization

Job description

Lead, Preclinical Development in Gene and Cell Therapies

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

Purpose & 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.

What awaits you at Astellas?

• Global collaboration: Become part of a connected global business of like‑minded life science leaders, all dedicated to improving patients' lives worldwide.
• Real‑world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
• Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
• A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

Values:

Innovation, Integrity and Impact sit at the heart of what we do.

Behaviors:

We come together as 'One Astellas', working with courage and a sense of urgency. We are outcome focused and consistently take accountability for our personal contribution.

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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