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Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .

This position is based in South San Francisco, CA. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.

Purpose and Scope:

The Associate Director, Veterinary Pathologist reports into the Senior Director, Applied Safety, and is considered a vital contributor to the team. The successful candidate will have the opportunity to support the progression of AAV-based gene therapy and cell 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 Senior Manager / Associate Director, Veterinary Pathologist will play a critical role in developing, implementing and executing the nonclinical and clinical strategies for cell and gene therapy programs. The successful candidate will partner with internal scientists, clinicians and external experts to advance transformational treatments for patients.

Essential Job Responsibilities:

+ Represent the toxicology function as a subject matter expert on drug discovery and development project teams and provide guidance on strategies for safety characterization, prioritization and advancement of drug candidates

+ Plan and execute overall safety assessments as a project toxicologist

+ Lead discussions on the design, execution, data analysis and interpretation of toxicology studies.

+ Conduct 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 internal functions, CROs, academic and analytical laboratories to ensure the conduct and completion of high-quality studies and timely progression of programs.

Qualifications

Required:

+ Must be Board-certified veterinary pathologist

+ A minimum of 7 years of non-clinical 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.

Preferred:

+ Experience working with cell and gene therapy programs.

+ Experience working with rare disease indications **.**

Salary Range

$145K – $190K (NOTE: Final salary could be more or less, based on experience)

Benefits:

+ Medical, Dental and Vision Insurance

+ Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks

+ 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

Category Applied research and non-clinical safety

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans