Crescent Biopharma, Inc.
Associate Director, Non-Clinical Study Operations & Sample Management
Crescent Biopharma, Inc., Waltham, Massachusetts, United States, 02254
About Us
Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s 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 therapies either as single agents or as part of combination regimens to treat a range of solid tumors. For more information, visitwww.crescentbiopharma.comand follow the Company onLinkedInandX.
Position Overview Crescent is seeking an Associate Director, Non-Clinical Study Operations & Sample Management to support the coordination and execution of non-clinical studies and the tracking and management of clinical samples. This hybrid role serves as a critical link between non-clinical, clinical, and bioanalytical functions—ensuring study logistics, documentation, and communication are well-organized and aligned across teams. The ideal candidate is highly organized, detail-oriented, and proactive, with the ability to manage multiple priorities and foster effective cross-functional communication in a fast-paced, collaborative environment.
Responsibilities
Coordinate the planning and execution of non-clinical studies in collaboration with internal teams and external CROs.
Manage vendor communications and study documentation, including purchase orders, contracts, and invoices.
Facilitate the review and routing of study protocols, reports, and related documentation.
Contribute to the development and refinement of operational processes, SOPs, and tracking tools.
Oversee logistics related to the shipment of test article materials to external partners.
Track study timelines, deliverables, and report progress to internal stakeholders.
Lead non-clinical sub-team meetings by setting agendas, tracking action items, and ensuring follow-through on deliverables.
Maintain an internal database to track clinical study samples, including bioanalytical and biomarker specimens, ensuring data integrity and chain of custody.
Monitor sample inventory, location, and disposition in collaboration with bioanalytical and clinical operations teams.
Support coordination of sample shipments between clinical sites, laboratories, and storage facilities.
Partner with cross-functional teams to ensure alignment between operational tracking and analytical data.
Assist with sample-related queries and resolving discrepancies in sample tracking or documentation.
Contribute to process improvement initiatives in sample management and ensuring compliance with quality standards.
Education & Experience
Bachelor’s degree in life sciences or a related field with a minimum of 7 years of experience in non-clinical or clinical operations, sample management, or laboratory coordination.
Understanding of preclinical study workflows, clinical sample logistics, and regulated environments (GLP, GCP).
Strong organizational and time management skills with keen attention to detail.
Excellent written and verbal communication skills.
Proficiency with Microsoft Office and experience with data tracking systems or LIMS preferred.
Ability to manage multiple priorities, problem-solve independently, and work collaboratively in a team-oriented environment.
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.
Two, one-week company-wide shutdowns each year.
A commitment to your professional development, with access to resources, mentorship, and growth opportunities.
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.
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Position Overview Crescent is seeking an Associate Director, Non-Clinical Study Operations & Sample Management to support the coordination and execution of non-clinical studies and the tracking and management of clinical samples. This hybrid role serves as a critical link between non-clinical, clinical, and bioanalytical functions—ensuring study logistics, documentation, and communication are well-organized and aligned across teams. The ideal candidate is highly organized, detail-oriented, and proactive, with the ability to manage multiple priorities and foster effective cross-functional communication in a fast-paced, collaborative environment.
Responsibilities
Coordinate the planning and execution of non-clinical studies in collaboration with internal teams and external CROs.
Manage vendor communications and study documentation, including purchase orders, contracts, and invoices.
Facilitate the review and routing of study protocols, reports, and related documentation.
Contribute to the development and refinement of operational processes, SOPs, and tracking tools.
Oversee logistics related to the shipment of test article materials to external partners.
Track study timelines, deliverables, and report progress to internal stakeholders.
Lead non-clinical sub-team meetings by setting agendas, tracking action items, and ensuring follow-through on deliverables.
Maintain an internal database to track clinical study samples, including bioanalytical and biomarker specimens, ensuring data integrity and chain of custody.
Monitor sample inventory, location, and disposition in collaboration with bioanalytical and clinical operations teams.
Support coordination of sample shipments between clinical sites, laboratories, and storage facilities.
Partner with cross-functional teams to ensure alignment between operational tracking and analytical data.
Assist with sample-related queries and resolving discrepancies in sample tracking or documentation.
Contribute to process improvement initiatives in sample management and ensuring compliance with quality standards.
Education & Experience
Bachelor’s degree in life sciences or a related field with a minimum of 7 years of experience in non-clinical or clinical operations, sample management, or laboratory coordination.
Understanding of preclinical study workflows, clinical sample logistics, and regulated environments (GLP, GCP).
Strong organizational and time management skills with keen attention to detail.
Excellent written and verbal communication skills.
Proficiency with Microsoft Office and experience with data tracking systems or LIMS preferred.
Ability to manage multiple priorities, problem-solve independently, and work collaboratively in a team-oriented environment.
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.
Two, one-week company-wide shutdowns each year.
A commitment to your professional development, with access to resources, mentorship, and growth opportunities.
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.
#LI-CBIO
#J-18808-Ljbffr