Pioneering Medicines: Associate Director / Director, Clinical Operations

Flagship Pioneering, Inc.•Cambridge, MA

7h•$148,000 - $236,500•Hybrid

About The Position

Pioneering Medicines, an initiative of Flagship Pioneering, is building a world-class biopharmaceutical R&D capability focused on conceiving and developing life-changing treatments for patients by harnessing the power of Flagship's scientific platforms and applying those innovative approaches to serious diseases with unmet medical need. Unique to Pioneering Medicines’ approach is the opportunity to combine platforms to create truly novel and potentially transformative treatments. 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.

Requirements

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%.

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.
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.