Head, Non-Clinical & Translational Development

Boston, MA

Head of Non-Clinical and Translational Development 1118922

Job Scope & Purpose:

Our clinically ready partner is developing and driving both antibodies and small molecules focused in various blood based disorders and is seeking an experienced drug development leader to join their team. The ideal candidate for this role will have extensive expertise in DMPK, Toxicology and CRO Management with a keen ability to troubleshoot assays. With multiple potential INDs on the horizon, this could be a very exciting option for a growing leader seeking an ability to drive life changing research!

Primary Job Responsibilities:

  • Identify, map out and manage internally or externally all nonclinical and translational studies (including drug metabolism, pharmacokinetics and toxicology) that are required for compounds as they move from discovery through development
  • Communicate proactively the status and issues of programs to upper management and program teams
  • Review and interpret data, develop protocols and review and finalize reports
  • Contribute to CRO selection and qualification
  • Participate in budgeting
  • Participate in due diligence activities
  • Work with discovery and clinical teams to integrate activities and set forth appropriate strategies.
  • Author nonclinical toxicology, DMPK and biomarker sections of regulatory documents

Primary Job Requirements:

  • Ph.D. Pharmacology, Biochemistry, Toxicology or any other relevant field
  • At least 7 years of experience in the biopharmaceutical industry
  • In depth understanding of the regulatory requirements for nonclinical studies that support registration as well as the disciplines that conduct those studies
  • Past hands on experience with drug metabolism and pharmacokinetics studies
  • Expertise in nonclinical toxicology
  • Solid understanding of drug metabolism, bioanalysis, pharmacokinetics and clinical pharmacology study design, as well as translational biomarkers 
  • Expertise managing CROs, GLP and regulatory guidelines
  • Excellent communication and interpersonal skills, and proven success working in matrix environments

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.

atemple@stratacuity.com

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EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, 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 employeeservices@apexsystemsinc.com or 844-463-6178.