Pioneering Medicines: Associate Director​/Director, Clinical Operations

Position Summary

Pioneering Medicines is seeking an Associate Director or Director, Clinical Development Operations to join our growing team and take direct ownership of one or more early-phase clinical programs.

This role is being created in direct response to the expansion of Pioneering Medicines' clinical portfolio. The ideal candidate thrives in a lean, high‑ownership environment and is ready to step into full program stewardship from day one.

• Serve as the operational lead for one or more early‑phase clinical trials (Phase 1/2), owning end‑to‑end program execution from study start‑up through close‑out and CSR.
• Collaborate closely with the Clinical Development Team including clinical scientists, pharmacometricians, safety, biostatistics, data management, regulatory affairs, and quality.
• Lead or contribute to the design of clinical trials and clinical development plans, including protocol development, operational feasibility assessments, country/site selection, and recruitment strategy.
• Participate meaningfully in dose escalation meetings, DSMB preparations, IND/CTA submissions, and other key regulatory and governance milestones.
• Prepare and present program operational updates to internal stakeholders; develop materials for investigator meetings and advisory boards.

• Lead site start‑up, patient enrollment, monitoring, protocol compliance, and study close‑out activities with a hands‑on, accountability‑driven approach.
• Author and/or review clinical documents including protocols, IBs, ICFs, CSRs, pharmacy manuals, CRFs, DSURs, SAPs, and other trial‑related materials.
• Oversee clinical data systems and processes: CRF design and UAT, data review and discrepancy resolution, CRA training, and site performance oversight.
• Build and maintain accurate trial timelines, trackers, and operational status reports; proactively elevate timeline, budget, or resource risks.
• Manage trial budget including forecasting, tracking, and reconciliation; flag variances and develop mitigation plans.
• Ensure timely collection of clinical data, samples, and lab results; maintain TMF quality and audit readiness.

• Lead RFP processes for assigned program vendors; coordinate cross‑functional bid defense meetings, complete scorecards, and support selection decisions.
• Manage day‑to‑day relationships with CROs, clinical sites, IRBs, central labs, IWRS providers, and DSMBs to ensure high‑quality, timely deliverables.
• Review monitoring visit reports (MVRs), conduct oversight monitoring, and elevate issues related to site or CRO performance as needed.
• Develop and implement action plans to address protocol compliance, safety, data quality, and administrative issues at investigational sites or with CROs.
• Track and report on vendor KPIs, risk mitigation plans, and program milestones.

• Contribute to the development and continuous improvement of organizational processes, SOPs, templates, and operational standards.
• Support team onboarding and knowledge transfer; may provide informal mentorship to junior colleagues or contractors over time.
• Maintain current knowledge of ICH‑GCP, FDA, EMA, and other applicable regulatory requirements; apply expertise to ensure trial compliance.

• Bachelor's degree or higher (MS, PharmD, PhD a plus) in life sciences or a related field preferred.
• Minimum 10+ years of industry drug development experience, including:
• At least 5 years of direct clinical trial management experience with clear program ownership.
• Demonstrated experience executing early‑phase clinical trials including FIH and IND/CTA‑opening studies.
• Experience at startups or small biotech companies highly valued.
• Broad knowledge of drug development processes; strong working knowledge of ICH‑GCP, FDA, EMA, and other global regulatory requirements.
• Proven success managing multi‑site global clinical trials including oversight of timelines, budgets, and vendors.
• Deep experience with CRO and vendor selection, onboarding, and performance management.
• Working knowledge of key clinical systems including EDC, CTMS, RTSM, and eTMF; prior TMF QC and…