Alkermes Overview

Alkermes, Inc. is the U.S. operating company of Alkermes plc, a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to research, develop and commercialize, both with partners and on its own, pharmaceutical products that are designed to address unmet medical needs of patients in major therapeutic areas. Alkermes has a diversified portfolio of marketed products focused on central nervous system disorders such as addiction and schizophrenia and a pipeline of product candidates in the fields of neuroscience and oncology. Headquartered in Dublin, Ireland, Alkermes has a research and development ("R&D") center in Waltham, Massachusetts; an R&D and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio.

The following position is for Alkermes, Inc.

Scientist/Sr. Scientist, Nonclinical Operations - Toxicology, Contractor

Position Summary:

Primary responsibility for the Scientist-Nonclinical Operations is to ensure timely and high-quality deliverables from the Life Sciences-Toxicology organization to meet Alkermes' Discovery and Development goals; these deliverables include management/coordination of nonclinical safety study activities, contracts, timelines, documentation (protocols/reports), and regulatory submission documents. The role requires close interaction with external contract research organizations (CROs) and with Alkermes' toxicologists who have overall accountability to implement nonclinical development plans for drug candidates. This position may include travel up to 5%.

Responsibilities:

• Vendor management, including but not limited to, assisting in CRO selection, soliciting proposals, contract work, and monitoring CRO performance via compliance to protocols/GLP regulations. Team member will participate in CRO interactions throughout all stages of nonclinical study conduct (eg, study proposal through report finalization);


• Participation in on-site study evaluations at CROs;


• Assisting toxicologists in the review of protocols, study reports, and protocol/report amendments for external studies to ensure high quality deliverables from CROs;


• Coordination of study-related activities with Alkermes' toxicologists and other Alkermes' groups supporting nonclinical studies (eg, Project Management, Analytical R&D, Formulations, Bioanalytical, Regulatory, Finance, and Legal), and CROs to ensure program needs and timelines are met;


• Tracking nonclinical study milestones against project goals;


• Participation in regulatory submissions (eg, preparation and/or review applicable nonclinical sections of IBs, DSURs, INDs/CTAs, and NDAs/BLAs/MAAs;


• Act as nonclinical representative on cross-functional initiatives.

Education and Experience:

• For Scientist: BS/MS with 6-10 years of experience in biotech/pharma or CRO in a nonclinical safety assessment organization or Quality Assurance group; PhD with 0-3+ years of applicable experience;


• For Senior Scientist: BS/MS with 10-15 years of experience in biotech/pharma or CRO in a nonclinical safety assessment organization or Quality Assurance group; PhD with 3+ years of applicable experience;


• Familiarity with drug development process;


• Familiarity with nonclinical safety studies required for registration of drug candidates, including genetic toxicology, safety pharmacology, general toxicology, developmental and reproductive toxicology, and/or carcinogenicity studies;


• Significant knowledge of GLP regulations for the conduct of nonclinical studies;


• Knowledge of regulatory submissions and nonclinical safety guidance;


• Strong oral and written communication skills;


• Exceptional attention to detail;


• Ability to work successfully independently and within a team environment;


• Ability to navigate and solve problems in an interdisciplinary work environment.

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

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Experience Level:
Associate

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