This site uses cookies. To find out more, see our Cookies Policy

Associate Director, Toxicology/Study Monitor in Boston, MA at Apex Life Sciences

Date Posted: 12/7/2018

Job Snapshot

Job Description


Associate Director, Toxicology/Study Monitor, 919945

Job Scope & Purpose:

If you are seeking options in Toxicology and DMPK study monitoring then we have the company for you. Our growing Biotech client, located in Waltham, MA, is developing their preclinical pipeline in unmet rare disorders. They are seeking a seasoned Toxicology expert to work with their CRO partnerships and oversee studies to ensure clinical delivery on programs. You will need a broad skill-set in toxicology, DMPK, bioanalytical assays and in addition, experience with overseeing managing outsourced CRO activities and responsibilities for budgeting and delivery according to deadlines. You also will bring a passion to this team for helping patients with rare diseases. Please reach out to Chris Clancy today to learn more.

Primary Job Responsibilities:

  • Manage and oversee operational activities and on-site monitoring of preclinical studies and oversight of preclinical studies conducted out-of-house with Contract Research Organizations.
  • Ability to coordinate with internal project teams the CRO deliverables and successfully plan for and lead successful outcomes and timelines.
  • Previous experience with assessing and budget oversight for CRO partnerships is necessary.
  • Dedication to hop on a plane when necessary to visit CRO partners is necessary for success in this role. Mostly domestic or North American travel a few times a month at most.
  • Ability to prepare and present on preclinical data packages under GLP and FDA guidelines and in accordance with study protocols.
  • Assists in the planning and preparation for study-related meetings with internal as well as external collaborators
  • Maintains study tracking tools and study calendars
  • Works closely with various functional groups, and CROs to ensure adequate nonclinical documentation

Primary Job Requirements:

  • B.S. or M.S. 10+ years industry or equivalent in pharmacology, toxicology or a related discipline.
  • Preferred experience in growing virtual biopharmaceutical environment would be ideal.
  • Experience as a study monitor working with project management tools in a preclinical setting is essential.
  • Previous work under GLP and regulatory requirements for the conduct of Toxicology, DMPK, and Bioanalytical studies
  • Ability to work in a biotech under ever-evolving demands is a must.

About Stratacuity: 

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

PROVEN SCIENTIFIC PLACEMENT™ 

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us at info@stratacuity.com or 877-787-2821.

Code: DiscDevt

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




919945