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Astellas Pharma Non-Clinical Study Manager in South San Francisco, California

About Astellas Gene Therapies

Astellas Gene Therapies is an Astellas Center of Excellence developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for their newly-created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information, please visit our website: https://www.astellasgenetherapies.com/

About Astellas

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at https://www.astellas.com/en.

Our Values:

  • Be BOLD (Find a Way)

  • Care Deeply -- for our patients, each other and our work

  • #GSD (Get Stuff Done)

What is the catalyst for you in your professional career? Are you ready to be a part of a bold, innovative company, to make a change and to make a difference? Listed below is a current opening for a smart, driven, experienced, and just plain nice individual who wants to join us and be a part of our journey.

The Role

Reporting to the Associate Director of Study Management, and as an integral member of the Research Function, the Nonclinical Manager will play a critical role in developing, implementing and executing the nonclinical strategy for Astellas Gene Therapy programs. Leveraging and harnessing Astellas Gene Therapy core competencies in AAV gene therapy, the selected candidate will be responsible for executing the translational strategy in neuromuscular orphan indications. The Manager will work cross-functionally with internal program teams and Contract Research Organizations (CROs).

Primary Responsibilities

  • The Nonclinical Manager will be responsible for selecting, contracting, and monitoring non-GLP and GLP-outsourced nonclinical studies with CROs, expert consultants and academic collaborators.

  • Review, edit, and finalize non-GLP and GLP nonclinical study protocols, amendments, and reports, ensuring that documents meet project timelines, expectations, and deliverables, as well as global regulatory and compliance requirements.

  • Write, edit and review nonclinical sections of regulatory documents and filings for global health authorities.

  • In close collaboration with scientists in Translational Science, analyze, interpret and summarize nonclinical proof-of-concept and safety data, and present them to internal project and senior management teams.

  • Maintain a current understanding of pharmacology and toxicology literature, as well as the scientific literature related to indications and platforms pursued by Astellas.

  • CRO oversight with minimal supervision, ensuring protocol and GLP compliance adherence for proper dosing and study execution.

  • Responsible for data management and document archiving of nonclinical studies.

  • Committed to implementing 3Rs principles in animal studies.

About You

Must Have/Required:

  • MS with 2+ years or BS with 5+ years of pharmaceutical, biotechnology or CRO industry experience in a nonclinical role, and 2-5+ years of experience with animal models, designing experiments that supported progression of candidates to the clinic.

  • Solid understanding and demonstrated experience with ICH, FDA and EMA nonclinical testing guidelines.

  • Familiarity with product quality, bioanalytical assay development and validation.

  • Experience independently developing and executing first-in-human nonclinical programs and in preparing IND and BLA/MAA filings.

  • Strong study management track record excelling in nonclinical project management skills.

  • Detail oriented with a good working knowledge of GLP and GMP regulations.

  • Excellent oral, written presentation and communication skills.

  • Excellent interpersonal, organizational and problem-solving skills required to manage multiple studies at different phases.

  • Solid understanding of animal welfare regulations (IACUC, USDA, and OLAW).

  • Willingness to travel and monitor outsourced studies.

  • Models our Core Values: Be Bold: Find a Way, Care Deeply, Get Stuff Done -- is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted.

  • Travel 10-15% for the United States; potential for global travel as well.

May Have/Preferred

  • Experience with transgenic animal models of disease, including establishment of novel lines and developing/maintaining animal colonies for use in research studies.

  • Direct experience with in vivo studies, including dosing, animal care, and tissue collections and/or have a track record managing outsourced studies.

  • Understanding of gene therapy and/or novel biologics concepts and methodologies, in particular as it relates to nonclinical study design and data analysis.

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

  • Referral bonus program

#LI-SS

Category Pharm - TOX

Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

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