Pioneering Medicines: Director, Clinical Development Operations

What if…

We could harness the power of Flagship’s scientific platforms and create novel treatment options that benefit more patients, sooner?

Pioneering Medicines 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.

Flagship Pioneering conceives, creates, resources, and develops first-in‑category life science platform companies to transform human health and sustainability. Since its founding in 2000, the firm has originated and fostered the development of more than 100 scientific ventures, resulting in over $34 billion in aggregate value, 500+ issued patents, and more than 50 clinical trials for novel therapeutic agents.

Pioneering Medicines is seeking a curious, driven professional to support Clinical Development for one or more early development programs. This hybrid role combines the strategic insights of a Clinical Scientist with the operational expertise of a Clinical Trial Manager. The ideal candidate will have experience driving early‑phase clinical development, including the design and execution of innovative trials.

The individual will be responsible for the successful conduct of clinical trials, focusing on both operational and administrative aspects with a hands‑on approach. They will lead trial teams, provide supervision and oversight of third‑party providers, and ensure timely performance of all services. Additionally, they will provide input into the operational aspects of protocol development and other clinical trial documents in close collaboration with clinical trial team members.

• Lead and/or support the design, execution, analysis, interpretation, and reporting of early-phase clinical studies within a matrixed and collaborative team environment.
• Collaborate across key internal work streams including clinical development, pharmacometrics, safety, clinical pharmacology, biostatistics, data management, regulatory affairs, and quality to drive cohesive and compliant trial execution.
• Contribute to the development and refinement of organizational processes, procedures, and standards to promote operational excellence and regulatory compliance.
• Prepare and participate in the preparation of presentations of trial data for internal and external parties.
• Organize and participate in investigator meetings and advisory boards to support trial execution and strategic planning; develop and maintain excellent working relationships with clinical investigators and key opinion leaders.
• Maintain up-to-date clinical and scientific expertise in relevant therapeutic areas, staying current by reviewing literature, attending conferences, and engaging with experts.
• Provide strategic input into clinical development plans within the Pioneering Medicines portfolio and across the broader Flagship ecosystem.

• Manage essential elements of clinical trial planning and execution, including operational feasibility assessments, country/site selection, safety and medical monitoring oversight, and participation in key forums such as dose escalation meetings and study close‑out activities.
• Lead or support development of critical clinical documents including protocols, investigator brochures (IBs), informed consent forms (ICFs), clinical study reports (CSRs), IND/CTA submissions, EU CTR modules, Pharmacy Manuals, CRFs, safety reports, protocol deviations, DSURs, SAP, site recruitment materials, and other trial‑related materials.
• Oversee clinical data systems and processes: support CRF design and user acceptance testing (UAT), monitor data review and discrepancy resolution, and coordinate CRA/site training as needed.
• Build, manage, and maintain clinical trial timelines, trackers, and operational…