Senior Manager / Associate Director, Clinical Sample Operations

Crescent Biopharma•Waltham, MA

11d

About The Position

The Senior Manager / Associate Director, Clinical Sample Operations leads strategic operational planning, logistical execution, and oversight of biosample management across Crescent Biopharma’s global clinical trial portfolio. The role partners with Clinical Operations, Clinical Science, Clinical Development, Translational Medicine, Clinical Pharmacology, Non-Clinical, and 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 successful candidate combines program and project management capabilities, laboratory vendor-management expertise, and detailed knowledge of the clinical sample lifecycle. This is a hands-on, collaborative leadership role requiring anticipation of operational risks and development of practical solutions in a fast-paced biotechnology environment.

Requirements

Bachelor’s degree in life sciences, biology, bioengineering, healthcare, or a related scientific discipline.
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.
Demonstrated knowledge of the clinical sample lifecycle, laboratory operations, chain of custody, sample logistics, assay workflows, data transfers, and sample data reconciliation.
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.
Exceptional cross-functional stakeholder-management skills and ability to build alignment with internal teams and external partners.
Strong strategic planning, project management, prioritization, and vendor-governance capabilities.
Acute attention to detail and commitment to data integrity, quality, and compliance.
Excellent written and verbal communication skills, including ability to translate complex scientific and operational requirements into clear plans and decisions.
Proactive, solutions-oriented mindset and judgment to resolve logistics issues in real time.
Ability to work in a fast-paced, highly collaborative, evolving biotechnology environment while managing multiple studies and priorities.

Nice To Haves

An advanced degree.
Direct experience supporting oncology clinical trials involving complex, multi-assay biomarker strategies.

Responsibilities

Partner with cross-functional teams to translate scientific and development objectives into executable study-level sample management plans.
Review protocols, Investigator’s Brochures, informed consent forms, and related study documents to ensure sample collection, processing, testing, storage, future-use, and destruction requirements are scientifically aligned, operationally feasible, and clearly defined.
Lead authoring, cross-functional review, approval, and maintenance of study-specific laboratory manuals, sample collection instructions, and related site materials.
Oversee design, production, distribution, inventory, and replenishment of sample collection kits for global investigative sites.
Represent Clinical Sample Operations on cross-functional study teams; identify risks and implement mitigation and escalation plans to protect sample quality and study timelines.
Oversee the 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.
Coordinate global shipment strategies and resolve issues involving couriers, customs, import/export requirements, temperature excursions, sample integrity, and site compliance.
Lead development, implementation, validation support, and optimization of sample tracking systems and laboratory information management systems across clinical studies.
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.
Develop portfolio- and study-level dashboards showing sample collection, shipment status, assay readiness, discrepancies, and operational risk.
Select, contract with, budget for, and oversee central laboratories, specialty laboratories, biorepositories, and logistics vendors.

Benefits

Competitive compensation, including base salary, performance bonus, and equity.
100% employer-paid benefits package.
Flexible PTO; vacation is described as unlimited PTO.
Two one-week company-wide shutdowns each year, with holiday pay including company shutdowns.
Professional development resources, mentorship, and growth opportunities.
Medical, dental, vision, life insurance, and short- and long-term disability coverage for eligible employees and/or dependents, subject to plan terms.
Company savings plan (401(k)), subject to plan terms.
Eligibility to participate in the Company’s long-term incentive program.
10 sick days per calendar year, subject to applicable policies and date of hire.
16 weeks of parental leave within one year of the birth, adoption, or foster care of a child, subject to applicable policies and date of hire.
FMLA and military leave.