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Jobs · Information Technology · Massachusetts

Pioneering Medicines: Associate Director / Director, Clinical Operations

Flagship Pioneering · Cambridge, MA · 2 wk ago
HybridInformation Technology$148k–$237k/yrFull-time

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.

Key Responsibilities

  • 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 escalate 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.

  • CRO, Site & Vendor Management: 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 escalate 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.

Qualifications

  • 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 audit readiness experience required.
  • Ability to operate effectively in lean, matrixed, fast-moving environments with a high degree of autonomy.
  • Excellent cross-functional collaboration and communication skills; strong project planning and problem-solving capabilities.
  • Experience in metabolic diseases, obesity, oncology and/or rare diseases highly desirable.
  • Willingness and ability to travel domestically and internationally up to 10%.

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