Associate Director/Director, Bioanalysis

Crescent Biopharma; Waltham (MA); On-site; USD 170,000 - 220,000; Full time

Benefits offered by this job

Competitive compensation

100% employer-paid benefits

Flexible PTO and company-wide shutdown

Professional development opportunities

Job summary

Crescent Biopharma is seeking an Associate Director/Director of Bioanalysis to lead the Bioanalytical Department and guide the bioanalysis strategy for its oncology pipeline. You will manage CROs, develop BA plans, and ensure timely transfer and reporting of PK data from preclinical and clinical studies.

Responsibilities include regulatory document contributions, QA collaborations, and adherence to GLP/GCP; strong cross-functional collaboration is required.

Qualifications

• PhD or MS in Chemistry, Pharmaceutical Sciences, Pharmacokinetics or related discipline with 8+ years for Associate Director; 10+ years for Director.
• Strong understanding of bioanalytical tech/methods for small and large molecules and peptides.
• Proven ability to manage external CROs and collaborate with internal stakeholders.
• Experience in drug development concepts and cross-functional teams.

Responsibilities

• Manage the Bioanalytical Department and develop internal processes for quality and continuity.
• Develop Bioanalytical strategy for the pipeline.
• Oversee bioanalytical contracts/SOW, plans, and reports to meet regulatory and scientific requirements.
• Coordinate BA data deliverables across programs with internal teams and CROs.
• Review protocols and reports; contribute to IND/CTA/BLA regulatory documents.
• Audits of CROs in collaboration with QA and ensure GLP/GCP adherence.

Skills

Bioanalysis leadership

CRO management

Strategic planning

Regulatory documentation

Education

PhD/MS in Chemistry/Pharmaceutical Sciences/Pharmacokinetics

Job description

Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s clinical-stage pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates. By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapiesas single agentsand as part of combination regimens to treat a range of solid tumors. For more information, visit www.crescentbiopharma.com and follow the Company on LinkedIn and X.

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

The salary range for this position is $170,000 to $220,000.

The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation – Unlimited PTO; Sick time – 10 days per calendar year; Holiday pay, including two Company shut downs; Parental Leave – 16 weeks within one year of the birth/adoption/foster care of a child; FMLA; Military Leave. Additional information can be found - https://www.crescentbiopharma.com/careers/#benefits

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.