Massachusetts Green Jobs

MassHire JobQuest Logo

Job Information

Astellas Pharma Director, Preclinical Development, Stem Cell Therapies in Westborough, Massachusetts

Director, Preclinical Development, Stem Cell Therapies

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 .

Astellas Institute of Regenerative Medicine (AIRM) is a wholly-owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.

AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.

Astellas is announcing a Director, Preclinical Development, Stem Cell Therapies opportunity at their Astellas Institute of Regenerative Medicine (AIRM) site in Westborough, MA.

Purpose:

This Director of Preclinical Development (Pharmacology and Toxicology) will report to the Head of Technical Operations and be responsible for the nonclinical pharmacology and toxicology studies conducted on behalf of AIRM at Contract Research Organizations (CROs) or other external collaborators. The successful candidate will also represent Preclinical Development on project teams to support the development of Stem Cell Therapy clinical candidates.

Essential Job Responsibilities:

  • Serve as study monitor for the design, conduct and reporting of nonclinical Pharmacology and Toxicology studies for Cell Therapy programs performed at Contract Research Organizations (CROs) to ensure a quality final product.

  • Write and edit nonclinical study outlines and protocols.

  • Scientific and technical reviewer for nonclinical studies performed with external collaborators or CROs.

  • Review and finalize study reports (both non-GLP and GLP studies), in conjunction with study director or internal program lead.

  • Build and develop partnerships with CROs.

  • Responsible for Preclinical Development SOPs and guidelines.

  • Act as Preclinical Development representative on project teams for the development of novel therapeutic drugs and targets.

  • Write and review nonclinical safety documentation (IBs, IMPDs, INDs & BLAs).

  • Communicate with regulatory agencies to resolve nonclinical issues and work with RA to seek guidance where necessary.

  • Present, discuss and review issues within R&ED and other stakeholders.

  • Work cross-functionally across the organization, including Regulatory, CMC, Clinical Dev, Quality Assurance, Analytical Dev and other groups.

Quantitative Dimensions:

  • Work cross functionally within Astellas and CROs

  • Experience with budgets and planning, with ability to manage Requisitions and project spend.

  • Direct impact to the design and costing of non-clinical studies performed with external collaborators.

Organizational Context:

  • Reports to the Head of Technical Operations

Qualifications:

Required:

  • PhD. in Biomedical Sciences (e.g., Toxicology, Pharmacology, Veterinary) with 14 years' relevant experience strongly preferred; M.S. with 20 years' Toxicology or Pharmacology experience or BS with 25+ years' experience may be considered.

  • Drug development experience, with minimum 8 years working in industrial pharmacology/toxicology OR at least 5 years' experience in pharmacological related sciences in academia or industry setting.

  • Experience in coordination, organization, analysis, and documentation of nonclinical studies

  • Experience with cell therapy, in particular working with stem cell derived product is desirable, but not required as training will be provided

  • Ability to synthesize, organize, and analyze diverse, multidisciplinary data sets

  • Excellent scientific writing and editing as well as written/oral communication skills

  • Ability to work independently and collaborate with a multi-disciplinary group in a goal- and team- oriented setting

  • Availability to travel to CROs for study monitoring activities

  • Proficiency with MS Office and common laboratory software (GraphPad Prism, etc.).

  • Working knowledge of regulatory guidelines relevant to preclinical development

  • Understanding of FDA and OECD Good Laboratory Practice.

Preferred:

  • Experience with cell and gene therapy and/or biologics

  • Knowledge of eCTD elements and structure

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-LK

Category Research and Development

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

EOE including Disability/Protected Veterans

DirectEmployers