---
title: 'Senior Manager / Associate Director, Clinical Sample Operations at Crescent Biopharma'
canonical: 'https://feeny.ai/job/senior-manager-associate-director-clinical-sample-operations-crescent-biopharma-t0tqhafxsznv'
type: 'job'
last_seen: '2026-11-05'
---

# Senior Manager / Associate Director, Clinical Sample Operations at Crescent Biopharma

- **Company:** Crescent Biopharma
- **Location:** Waltham, MA
- **Work type:** onsite
- **Posted:** 2026-10-15
- **Last confirmed live:** 2026-11-05
- **Apply:** https://jobs.lever.co/crescent-biopharma/c94c9ea4-1542-4992-aebc-9c802a9dbf0c

## 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 therapies as single agents and as part of combination regimens to treat a range of solid tumors. For more information, visit [www.crescentbiopharma.com](https://nam13.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DiRbGFgYP6ltuiKaWJMN-VqRAUqbWyUxrmINzdOIECYaBWd3lJ0VJpvt0RztrdQbPeHwI5phjZuWBlxxP81IIOhkFOP51sIbw1UZv0ra8-eTDPRGUAn7Q1_5TPXufY0ZK&data=05%7C02%7Ckristy.cobill%40crescentbiopharma.com%7C3a4262d820fa463f09da08ddad2d1944%7Cea3ae1e37f5f46159580d5c6e0711b3c%7C0%7C0%7C638857131411125658%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=20GPURqhaN9PyX5kPzV9huwRgWvPYrjlitHt8f8lCWA%3D&reserved=0) and follow the Company on [LinkedIn](https://nam13.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DZynOklBsETaAfH9zH2DZEKtm2QIV5CK8UcnS9y6rRnnBoDmbzTBHYckQrAowGdQcF-vO51wYRLIdTpjropqMIuGZKs71FyBQHIO36f-i6NPlEJYQr6TqZo7-QL09KdaK&data=05%7C02%7Ckristy.cobill%40crescentbiopharma.com%7C3a4262d820fa463f09da08ddad2d1944%7Cea3ae1e37f5f46159580d5c6e0711b3c%7C0%7C0%7C638857131411150941%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=QbTAUqmmjbU837K8weJfxn32FaezBQe0bts0p4xsfow%3D&reserved=0) and [X.](https://nam13.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3D3__lb7yjpqgEJ82HQ24CTgcOho5ccwJkXdDrHXdzjIaCIyyAeau0lTzX4YedcsQ3ox_RgjYQLcRTGAuNCsS_vw%3D%3D&data=05%7C02%7Ckristy.cobill%40crescentbiopharma.com%7C3a4262d820fa463f09da08ddad2d1944%7Cea3ae1e37f5f46159580d5c6e0711b3c%7C0%7C0%7C638857131411169359%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=awcJCwsV7hPJUS%2Fy9ynDZhEXNbcC3i3QToEEGObUxIY%3D&reserved=0)

The Senior Manager / Associate Director, Clinical Sample Operations will lead the strategic operational planning, logistical execution, and oversight of biosample management across Crescent Biopharma’s global clinical trial portfolio. This role partners across Clinical Operations, Clinical Science, Clinical Development, Translational Medicine, Clinical Pharmacology, and Non-Clinical, and with external laboratory partners, to ensure clinical trial specimens—including biomarker, pharmacokinetic/pharmacodynamic, genomic, and other specialty samples—are collected, processed, tracked, shipped, stored, and analyzed in accordance with protocols, timelines, quality standards, and regulatory requirements.

The ideal candidate combines strong program and project management capabilities, deep laboratory vendor-management expertise, and a meticulous understanding of the clinical sample lifecycle. The successful candidate will be a hands-on, collaborative leader who anticipates operational risks and develops practical solutions in a fast-paced biotechnology environment.

## Responsibilities

Strategic Operations & Trial Lifecycle Support

Sample strategy execution: Partner with Clinical Operations, Clinical Science, Clinical Development, Translational Medicine, Clinical Pharmacology, and Non-Clinical to translate scientific and development objectives into executable study-level sample management plans.

Protocol and informed consent input: Collaborate with Clinical Science, Clinical Development, Translational Medicine, Clinical Pharmacology, Non-Clinical, and Clinical Operations to review clinical protocols, Investigator’s Brochures, informed consent forms, and related study documents and confirm that biological sample collection, processing, testing, storage, future-use, and destruction requirements are scientifically aligned, operationally feasible, and clearly defined.

Laboratory manual oversight: Lead the authoring, cross-functional review, approval, and maintenance of study-specific laboratory manuals, sample collection instructions, and associated site materials.

Collection kit readiness: Oversee design, production, distribution, inventory, and replenishment of sample collection kits for global investigative sites.

Study execution: Represent Clinical Sample Operations on cross-functional study teams comprising Clinical Operations, Clinical Science, Clinical Development, Translational Medicine, Clinical Pharmacology, Non-Clinical, and other relevant functions; proactively identify risks and implement mitigation and escalation plans to protect sample quality and study timelines.

Sample Logistics, Tracking & Data Integrity

Chain of custody: Maintain oversight of the complete end-to-end lifecycle and chain of custody of clinical samples from site collection through transport, receipt, processing, testing, transfer, long-term biorepository storage, return, or final destruction.

Global logistics: Coordinate shipment strategies and resolve time-sensitive issues related to couriers, customs, import/export requirements, temperature excursions, sample integrity, and site compliance.

System implementation: Lead the development, implementation, validation support, and optimization of sample tracking systems and laboratory information management systems across clinical studies.

Data reconciliation: Oversee routine cleaning and reconciliation of sample metadata across electronic data capture systems, interactive response technologies, laboratory data transfers, and sample tracking platforms to support interim analyses and database lock timelines.

Metrics and reporting: Develop portfolio- and study-level dashboards that provide visibility into sample collection, shipment status, assay readiness, discrepancies, and operational risk.

Education & Experience

- Bachelor’s degree in life sciences, biology, bioengineering, healthcare, or a related scientific discipline is required; an advanced degree is preferred.
- Senior Manager level: Typically 6–8+ years of progressive experience in clinical operations, clinical sample management, biomarker operations, laboratory operations, or a related function within biotechnology, pharmaceutical, or contract research organizations.
- Associate Director level: Typically 8–10+ years of relevant experience, including at least 2–3 years of direct people management or leadership of matrixed project teams.
- Direct experience supporting oncology clinical trials involving complex, multi-assay biomarker strategies is strongly preferred
- Demonstrated knowledge of the clinical sample lifecycle, laboratory operations, chain of custody, sample logistics, assay workflows, data transfers, and sample data reconciliation, with the ability to integrate requirements across Clinical Operations, Clinical Science, Clinical Development, Translational Medicine, Clinical Pharmacology, and Non-Clinical.
- Proven experience selecting, contracting with, budgeting for, and overseeing central laboratories, specialty laboratories, biorepositories, and logistics vendors.
- Working knowledge of ICH-GCP, GxP principles, global regulatory expectations, informed consent requirements, data privacy, and biospecimen-related ethical considerations.
- Proficiency with eTMF platforms, clinical trial management systems, electronic data capture platforms such as Medidata Rave, and sample tracking or LIMS solutions.

Core Competencies

- Exceptional cross-functional stakeholder-management skills, with the ability to build alignment across Clinical Operations, Clinical Science, Clinical Development, Translational Medicine, Clinical Pharmacology, Non-Clinical, and external partners.
- Strong strategic planning, project management, prioritization, and vendor-governance capabilities.
- Acute attention to detail and a consistent commitment to data integrity, quality, and compliance.
- Excellent written and verbal communication skills, including the ability to translate complex scientific and operational requirements into clear plans and decisions.
- Proactive, solutions-oriented, “roll-up-your-sleeves” mindset with the judgment and composure to resolve logistics issues in real time.
- Ability to thrive in a fast-paced, highly collaborative, and evolving biotechnology environment while managing multiple studies and priorities.

## 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.

Salary Range

The salary range for this position is $170,000 to $200,000. 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:

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. 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](https://nam13.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.crescentbiopharma.com%2Fcareers%2F%23benefits&data=05%7C02%7Clee.schwartz%40crescentbiopharma.com%7Ca470e7b902eb4129a1a808de166a540b%7Cea3ae1e37f5f46159580d5c6e0711b3c%7C0%7C0%7C638972843088266995%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=wT1Z9wts792%2FEuLYQJs2HxHxehSvTRx7cAguiMD4XY0%3D&reserved=0)

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.

## About Crescent Biopharma

## Company Overview
- **One-liner**: Crescent Biopharma is a clinical-stage oncology company developing next-wave cancer therapies, including a PD-1 x VEGF bispecific antibody and antibody-drug conjugates (ADCs) for solid tumors.
- **Entity Type**: Public (IPO in June 2025; ticker not disclosed in available data)
- **Headquarters**: Waltham, Massachusetts, United States (300 Fifth Avenue, Waltham, MA 02451)
- **Founded**: Year not publicly available (company appears to have been active before 2024; IPO in 2025)
- **Founders**: Not publicly available (leadership includes CEO Joshua Brumm, but founder information is not listed)

## Core Business
- **Primary industry/industries**: Oncology biotechnology / Therapeutics
- **Target customers**: B2B – primarily focuses on developing and commercializing cancer therapies, with partnerships and collaborations (e.g., Kelun-Biotech, Paragon Therapeutics)
- **Mission or purpose statement**: “Delivering the next wave of transformative therapies to bring a brighter future for people living with cancer.”

## Products & Services
- **CR-001 (PD-1 x VEGF bispecific antibody)**: A tetravalent bispecific antibody in Phase 1/2 clinical trials (ASCEND) for advanced solid tumors. Designed to exhibit cooperative pharmacology similar to ivonescimab; aims to restore T-cell activity and localize anti-VEGF activity in the tumor microenvironment. Collaboration with Kelun-Biotech for Greater China rights.
- **CR-002 (PD-L1–directed ADC)**: A topoisomerase inhibitor ADC targeting PD-L1, with high internalization. IND planned for mid-2026, with Phase 1/2 trial expected in H2 2026.
- **CR-003 (ITGB6–directed ADC)**: A differentiated ADC targeting integrin beta-6 (ITGB6), with a topoisomerase 1 inhibitor payload. Uses Kthiol conjugation technology. Licensed from Kelun-Biotech for ex-Greater China markets; Phase 1/2 trial ongoing in China.

## Market Standing
- **Valuation/Market Cap**: Not disclosed (public company as of 2025, but no valuation or market cap figure available in provided data)
- **Key Metric**: Total Funding: $585M (including $200M Series A in 2024, $185M Post-IPO Equity in 2025, and $200M Post-IPO Equity in 2025 led by Fairmount Funds Management)
- **Notable Investors/Partners**: Fairmount Funds Management, Venrock Healthcare Capital Partners, Kelun-Biotech (strategic collaboration), Paragon Therapeutics
- **Growth Signals**: Headcount grew 129.6% YoY to 55 employees (LinkedIn); IPO in June 2025; multiple pipeline programs advancing toward IND; expansion into ADC combination trials

## Competitive Advantages
- Focus on established, clinically validated targets (PD-1, VEGF, PD-L1, ITGB6) to reduce risk and accelerate development
- Multi-modality approach (bispecific antibodies + ADCs) enabling combination therapies with potential synergistic effects
- Proprietary ADC technology (Kthiol conjugation) and strategic collaborations for global rights to differentiated assets
- Strong leadership team with deep oncology drug development expertise (former executives from major biopharma)

## Strategic Focus
- Advance CR-001 as a foundational backbone therapy, with initiation of combination trials with ADCs in H2 2026
- Submit IND for CR-002 in mid-2026 and begin Phase 1/2 trials
- Progress CR-003 clinical program and explore additional internal and partnered ADC and immuno-oncology opportunities
- Build a leading oncology company through disciplined execution, leveraging established biology and multiple modalities

## Why Work Here
- **Culture highlights**: “No egos, collaborative spirit,” “roll up sleeves,” “move with urgency,” “data-driven science with patients as true north.” Emphasizes transparency, integrity, and impact.
- **Remote/hybrid/office policy**: Not explicitly stated; headquarters in Waltham, MA, with an office in Rockville, MD. Likely requires on-site presence given the “highly collaborative” and “urgent” culture.
- **Notable perks**: 100% employer-paid medical, dental, vision, short/long-term disability, life insurance; HSA and dependent care FSA; 401(k); subsidized lunch program; flexible vacation and paid holidays including summer and year-end office closures (one week each).
- **Best for**: Bold innovators who want to make a significant impact in oncology drug development, thrive in a fast-paced, transparent environment, and are motivated by patient outcomes.

## Sources
1. [crescentbiopharma.com – Careers](https://www.crescentbiopharma.com/careers/)
2. [crescentbiopharma.com – About](https://www.crescentbiopharma.com/about/)
3. [crescentbiopharma.com – Pipeline](https://www.crescentbiopharma.com/pipeline/)
4. [linkedin.com – Crescent Biopharma](https://www.linkedin.com/company/crescent-biopharma)
5. [jobs.lever.co – Crescent Biopharma](https://jobs.lever.co/crescent-biopharma)

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