Associate Director, Pre-Clinical Toxicology

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 either Westborough, MA or 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, Applied Safety (Toxicologist), 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 multiple therapeutic moieties, including small molecules, large molecules, and cell and gene therapy programs. As a member of Applied Research and Nonclinical Safety, this individual will play a critical role in developing, implementing and executing the nonclinical and clinical strategies for these programs, as well as supporting the safety of marketed products. The successful candidate will partner with internal scientists, clinicians and external experts to advance transformational treatments for patients.

Responsibilities and Accountabilities:

• 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.
• Monitor and manage studies performed at CROs.
• 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.
• Support post-marketing information updates from non-clinical safety perspectives and provide safety data and rationale in post-marketing clinical trials, if necessary.
• 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.

Required

• PhD in life science area (toxicology, biochemistry, cell biology, etc) and at least 7 years of experience in toxicology and/or regulatory science working in the pharmaceutical and/or biotech industry.
• Certification in toxicology (DABT preferred)
• Experience in the design, conduct and interpretation of GLP and non-GLP non-clinical studies.
• Strong understanding of drug discovery, development and regulatory processes.
• Demonstrated experience 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 on cell and gene therapy programs.
• Experience working on biologics and ADCs.
• Experience working on rare disease indications. 

Salary Range

$141,400 - $222,200 (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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