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Jobs · Business Development · Massachusetts

Associate Director/Director, Bioanalysis

Crescent Biopharma · Waltham, MA · 1 wk ago
On-siteBusiness Development$170k–$220k/yrFull-time

About the role

We are seeking an Associate Director/Director of Bioanalysis to provide strategic thinking and leadership of the Bioanalysis approach for Crescent’s Pipeline. You will manage the Bioanalytical department, be responsible for the design, analysis, interpretation, transfer, and reporting of the bioanalysis of pharmacokinetic data from preclinical and clinical studies. This role involves managing CROs utilizing state-of-the-art methodologies, including Ligand Binding and LC/MS/MS, while working closely with both internal stakeholders and external parties.

Responsibilities

  • Manage the Bioanalytical Department, develop internal processes to ensure quality and continuity.
  • Develop Bioanalytical Strategy for the pipeline.
  • Assist in the development of BA strategy to meet current analytic needs by managing the implementation of bioanalytical contracts/SOW, plans, and reports to ensure that the BA data meet current/future regulatory and scientific requirements.
  • Work with internal and external subject matter experts and other relevant disciplines to manage and resolve scientific, technical, or quality issues and improve study consistency, quality, efficiency, and effectiveness.
  • Coordinate the bioanalysis activities for individual preclinical/clinical programs to ensure alignment of BA data deliverables.
  • Manage CROs in their day-to-day operation of BA work, including coordination of shipments of test article, necessary reagents and samples, protocol and data review, provide technical assistance, and report review.
  • Contribute to regulatory documents (i.e., IND, CTA, BLA, etc.).
  • Conduct scientific audits of CROs in collaboration with the QA department.
  • Instill and adhere to GLP and GCP regulations, relevant SOPs, protocols, policies, and safety procedures.

Qualifications

  • PhD or MS in Chemistry, Pharmaceutical Sciences, Pharmacokinetics, or related discipline with considerable relevant industry experience (minimum 8+ years for Associate Director; 10+ years for Director).
  • Good understanding of bioanalytical technology/methods for small and large molecules and peptides.
  • Excellent organization skills and a strong background in managing external CROs.
  • Well-grounded experience in drug development concepts—data-driven decision making, functioning of project teams/sub-teams, development of protocols, clinical study reports, etc.
  • Ability to work in a dynamic, team-oriented environment as demonstrated by participating in and contributing to cross-functional teams.
  • Nice to have: small molecule DMPK experience.

Benefits

  • Opportunity to join a mission-driven team where you'll contribute to impactful work, take on varied responsibilities, and grow quickly in a dynamic environment.
  • Competitive compensation, including base salary, performance bonus, and equity.
  • 100% employer-paid benefits package (medical, dental, vision, life insurance, short- and long-term disability).
  • Flexible PTO; also, two one-week company-wide shutdowns each year.
  • Commitment to your professional development, with access to resources, mentorship, and growth opportunities.
  • Eligibility to participate in the Company’s savings plan (401(k)) and long-term incentive program.
  • Vacation: Unlimited PTO.
  • Sick time: 10 days per calendar year.
  • Holiday pay, including two company-wide shutdowns.
  • Parental Leave: 16 weeks within one year of the birth/adoption/foster care of a child.
  • FMLA and Military Leave eligibility.

Pay

The salary range for this position is $170,000 to $220,000. The final salary offered will depend on several factors, including relevant years of experience, educational background, and geography.

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