Associate Director, Preclinical Development

Brookline, MA

Associate Director/Director, Preclinical Development 1111904

Job Scope & Purpose:

Our exclusive, clinical stage, client is engineering a novel class of biologics to engage and modulate targets T cells within the body for the treatment of cancer, infectious diseases and autoimmune diseases. They are a high-growth, publicly traded company with significant clinical aspirations, including filing an IND every year moving forward. The team is seeking a leader in preclinical development to drive these INDs and work collaboratively with outsourced resources and consultants in toxicology, bioanalytical development and PK/PD. The company culture is fast-paced and committed to scientific excellence, innovation, and teamwork.

Primary Job Responsibilities:

  • Devising and overseeing execution of stage-appropriate bioanalytical and safety strategies as the strategic and scientific representative on project teams
  • Design, initiate, and monitor internal and external safety testing together with external consultants
  • Oversee internal teams, external vendors and collaborators to develop, qualify, transfer and validate bioanalytical assays to support discovery and development programs across the company's pipeline
  • Author and review technical reports and summary documents for regulatory filings as well as relevant sections of clinical documents, scientific presentations and publications
  • Maintain knowledge of regulatory expectations and industry standards for bioanalytical assays and nonclinical safety assessment

Primary Job Requirements:

  • Ph.D. in Toxicology, Pharmaceutical Science or related field
  • 10+ years of industry research experience and a track record of supporting advancement of novel therapeutic modalities into clinical testing 
  • Direct experience developing the data package supporting the clinical development of protein biologics
  • Firm understanding of bioanalytical methods and pharmacokinetics 
  • Track record of toxicology leadership in Oncology discovery and development programs
  • Knowledge of GLP compliance and relevant ICH & FDA guidance documents
  • Experience with IND preparation and submission, and regulatory interactions
  • Ability to work well with external CROs and collaborators 
  • Ability to work effectively both independently and collaboratively in a fast-paced, dynamic team-oriented environment
  • Ability to travel to monitor out-sourced studies as required and feasible
  • Outstanding organizational skills with the ability to prioritize and deliver against timelines for multiple projects simultaneously
  • Self-motivated, team- and goal-oriented scientist with excellent oral and written communication skills

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.