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Astellas Pharma Associate Director/Director, Anatomic Pathology in 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.

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.

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

The Associate Director/Director, Anatomic Pathology reports into the Senior Director, Pharmacology/Toxicology and be a vital contributor to the team. The successful candidate will have the

opportunity to support the progression of AAV-based gene therapy programs with a focus on investigating histological changes that may result from the transduction of host target cells and the expression of therapeutic proteins. As a member of the Research Department, the Associate Director/Director, Anatomic Pathology will play a critical role in developing, implementing and executing the nonclinical and clinical strategies for Astellas Gene Therapies' programs. The successful candidate will partner with internal scientists, clinicians and external experts to advance transformational treatments for patients with severe genetic diseases.

Responsibilities

  • The veterinary pathologist will participate in the design, execution, data analysis and interpretation of animal studies.

  • Conduct gross and microscopic examination of animal tissues from proof-of-concept, toxicology and natural-history studies.

  • Conduct peer reviews of studies performed at CROs.

  • Report pathology data in accordance with GLPs.

  • Communicate study results and their relevance to program teams, collaborators, senior management and regulatory agencies.

  • Review and draft relevant sections of regulatory submission documents such as CTAs, INDs, IBs and BLAs.

  • Collaborate with various Astellas Gene Therapies functions, CROs, academic or analytical laboratories to ensure the conduct and completion of high-quality studies and timely progression of programs.

  • The veterinary pathologist will be encouraged to lead pre-clinical stage gene therapy program teams.

About you

Must Have/Required

  • Board-certified veterinary pathologist

  • A minimum of 7 years of nonclinical anatomic pathology experience working in pharmaceutical, biotechnology or CRO companies.

  • Experience in the design, conduct and interpretation of GLP and non-GLP nonclinical studies.

  • Strong understanding of drug discovery, development and regulatory processes.

  • Evidence of supporting drug discovery/development programs across important milestones such as first-in-human dosing.

  • Excellent critical thinking and scientific skills, and a demonstrated ability to analyze, interpret, and clearly communicate complex results.

  • 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.

  • Up to 10% travel.

  • Models our Core Values: Be Bold, Care Deeply, #GetStuffDone -- is experienced as someone who exemplifies the culture we want to create; operates with transparency; is trusted

May Have/Preferred

  • Experience working with gene therapy programs.

  • Experience working with rare disease indications.

#LI-LK

Category Pharmacology and Toxicology

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

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