Clinical Trial Manager (f/m/d)

Clinical Trial Manager (f/m/d)

Location: New York / East Coast USA

Starting date: as soon as possible

Who We Are

Pentixapharm AG, together with its U.S. subsidiary Pentixapharm Inc., is a research-driven radiopharmaceutical and precision oncology company focused on the preclinical and clinical development, as well as manufacturing, of innovative theranostic agents. Its lead drug candidate pair, PentixaFor/PentixaTher, along with an antibody-based pipeline, targets the CXCR4 receptor. Target indications include hematologic and solid cancers, as well as cardiovascular and endocrine disorders.

Our vision is to expand the boundaries of radiopharmaceuticals.

Job Overview

The Clinical Trial Manager will sit at the operational interface between Pentixapharm, our investigator sites, and our CRO. Based in New York and working closely with our German-based clinical team, the role owns day-to-day site oversight and the CRO relationship for our registrational programs: tracking site activation and enrollment, resolving site-raised operational issues, holding the CRO to its contracted deliverables, and escalating only what genuinely requires sponsor-level decisions. This is a hands-on execution role in a small, senior team, with direct impact on the delivery of PentixaFor/PentixaTher and our broader pipeline.

Your Tasks

• Own day-to-day operational oversight of trial sites: activation tracking, readiness reviews, site communication, and early flagging of sites underperforming against enrollment and activation milestones
• Triage and resolve site-raised operational issues (query resolution, supply and logistics questions, documentation gaps) and coordinate monitoring visit follow-up until findings and action items are closed
• Serve as the primary point of contact to the CRO for day-to-day operational matters and own the CRO meeting cadence: scheduling, agendas, minutes, and action-item tracking across governance and working-level calls
• Track CRO deliverables against task order timelines, monitor scope to identify out-of-scope work, support task order and change order preparation, and reconcile deliverables against contracted scope
• Maintain the CRO issues and risk log, report status to internal stakeholders, and coordinate cross-functionally with regulatory, medical, imaging, biostatistics and pharmacovigilance so that sites and the CRO have what they need to execute

Experience & Skills

• Several years of clinical operations experience in pharma or biotech, spanning both site management and CRO oversight on global Phase 2 or Phase 3 trials
• Proven ability to operate as the operational interface between sponsor, sites and CRO, holding each accountable without needing escalation for every issue
• Working knowledge of ICH-GCP, FDA regulations governing clinical trial conduct (21 CFR Parts 11, 50, 56 and 312), site monitoring processes, and CRO vendor governance including task orders, change orders and meeting governance
• Strong organizational and follow-through skills; comfortable owning trackers and issue logs and driving them to closure; clear and direct written and verbal communication suited to a small, fast-moving team
• Experience in diagnostic imaging trials, radiopharmaceuticals or nuclear medicine is an advantage; PMP or equivalent is a plus; fluency in English required, German a plus; able to maintain regular working overlap with our German team

What We Offer

• Meaningful mission : Develop innovative radiopharmaceuticals that improve patients' lives.
• Impactful work: High responsibility in a dynamic, science-driven environment.
• Flexibility : Flexible hours and hybrid work from our New York office.

With us, ideas turn into action!

Thanks to our flat hierarchies and innovation-oriented company culture, you'll have the opportunity to truly make an impact. We take pride in our collaborative work environment, built on mutual respect, appreciation, and a wide variety of engaging, meaningful tasks.