We are seeking an Associate Director/Director of Bioanalysis is 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. Further, this person will manage CROs utilizing state-of-the-art methodologies, including but not limited to Ligand Binding and LC/MS/MS, working closely with both internal stakeholders and external parties. Additional responsibilities include assisting in preparing and reviewing bioanalytical plans, protocols and reports to meet regulatory requirements and management of bioanalytical activities (budgeting, auditing CROs, setting up agreements etc).
Responsibilities
- Manage the Bioanalytical Department, develop internal processes to ensure quality and continuity.
- Develop Bioanalytical Strategy for the pipeline.
- Assisting 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
Education & Experience
- 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)
- Must have good understanding of bioanalytical technology/methods both for small and large molecules and peptides.
- Must have excellent organization skills and be highly regarded in the BA/PK area with a strong background with managing external CRO’s.
- Must have well-grounded experience in drug development concepts – data driven decision making, functioning of project teams/sub-teams, development of protocols, clinical study reports etc.
- Must have the ability to work in a dynamic team-oriented environment as demonstrated by participating in and contributing to cross functional teams is necessary.
- Nice to have small molecule DMPK experience
What We Offer
- 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
- Flexible PTO; also, two, one-week company-wide shutdowns each year
- A commitment to your professional development, with access to resources, mentorship, and growth opportunities
Salary Range
Please note:
Crescent Biopharma is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status.
Please note, Crescent does not accept unsolicited resumes from external agencies or recruiters. Submission of a resume without a prior written agreement does not create any express or implied contract between Crescent and the agency. Crescent will not pay any fees related to unsolicited resumes.
#LI-CBIO
Skills Required
- PhD or MS in Chemistry, Pharmaceutical Sciences, Pharmacokinetics, or related discipline
- Minimum 8+ years relevant industry experience (Associate Director) or 10+ years (Director)
- Strong understanding of bioanalytical methodologies for small and large molecules and peptides (e.g., ligand binding, LC/MS/MS, PK assays)
- Proven experience managing external CROs, including contracts/SOWs, oversight, technical coordination, and report review
- Experience with drug development processes: protocol and report development, data-driven decision making, and cross-functional team participation
- Experience contributing to regulatory documents (IND, CTA, BLA) and ensuring BA data meet regulatory requirements
- Ability to instill and adhere to GLP and GCP regulations, SOPs, and quality/safety procedures; conduct scientific audits
- Excellent organization and leadership skills; ability to manage department budget and vendor agreements
- Small molecule DMPK experience
What We Do
Crescent Biopharma, Inc. is a clinical-stage biotechnology company dedicated to advancing the next wave of transformative therapies for cancer patients. The company focuses on developing high-impact cancer medicines, including its lead program, CR-001 (a PD-1 x VEGF bispecific antibody), and a portfolio of novel antibody-drug conjugates (ADCs) designed to treat a range of solid tumors.
