Senior Bioanalytical and Biomarker Development Lead

3 weeks ago

Old Toronto, Ontario, Canada Menlo Ventures Full time
Transformative Opportunity in Bioanalytical and Biomarker Development

Menlo Ventures is seeking a highly skilled and experienced professional to lead our bioanalytical and biomarker development efforts. As Associate Director of Bioanalytical and Biomarker Development, you will play a critical role in driving the success of our clinical development pipeline.

Key Responsibilities:

  • Develop and execute bioanalytical and biomarker strategies to support our clinical pipeline.
  • Collaborate with internal teams to define and execute bioanalytical and biomarker plans.
  • Liaise with external vendors to propose, trouble-shoot, and validate analytical methods.
  • Support pharmacokinetic and pharmacodynamic modelers with high-quality, fit-for-purpose data.
  • Partner with Clinical Operations to ensure appropriateness of sample collection, transport, and analysis.
  • Work with Quality and Regulatory Assurance to confirm analysis at the appropriate rigor to serve desired reporting requirements.

Requirements:

  • PhD with 2+ years, MS with 5+ years, or Bachelor's with 10+ years of Industry experience.
  • Degree in chemistry, biology, biochemistry, or related discipline with an emphasis on analytical techniques suitable for the extraction and analysis of target compounds from complex biological matrices.
  • Previous experience working with or within CRO organizations.
  • Previous experience working in the biopharma industry preferred.
  • Strong working knowledge of regulations, guidelines, standards that guide collection and utilization of non-clinical and clinical samples and data.
  • Familiarity with regulatory expectations (FDA and EMA) and industry's best practices in bioanalytical and biomarker/diagnostic assay method development and validation.
  • Ability to diagnose and solve complex technical and scientific problems.
  • An understanding of principles of relationship management across diverse internal and external stakeholders.

What We Offer:

  • A dynamic and collaborative work environment.
  • Opportunities for professional growth and development.
  • A competitive compensation and benefits package.

Menlo Ventures is an Equal Opportunity Employer that values diversity and inclusion. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, local, or provincial human rights legislation.

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