Associate Director, Clinical Scientist

Ironwood Pharmaceuticals is a leading global gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS (linaclotide), the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation or chronic idiopathic constipation. Ironwood is also advancing apraglutide, a next-generation, long-acting synthetic GLP-2 analog being developed for rare gastrointestinal diseases, including short bowel syndrome with intestinal failure.

Building upon our history of GI innovation, we keep patients at the heart of our R&D and commercialization efforts to reduce the burden of GI diseases and address significant unmet needs.  Founded in 1998, Ironwood Pharmaceuticals is headquartered in Boston, Massachusetts, and has operations in Basel, Switzerland.

Position Summary:

As part of Clinical Development and working closely with the Global Clinical Development Lead and Medical Director, the Clinical Research Scientist serves as the primary day-to-day clinical science contact for assigned studies. The role leads and coordinates clinical science activities across study planning, protocol development and execution, data review and interpretation, and reporting, while ensuring cross-functional alignment and timely resolution and escalation of study-level issues.

The Clinical Research Scientist partners closely with Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, and Patient Safety and provides clinical development input into regulatory responses, briefing books, and related documents. The Medical Director retains ultimate accountability for medical oversight, final medical and scientific decisions, and external medical engagement.

Location:

Boston, MA or Basel, Switzerland.

Work Authorization:
Ironwood is unable to provide visa sponsorship or relocation assistance for this position at this time.

Essential Functions:

Serve as the primary day-to-day point of contact for assigned studies and lead study-level clinical science coordination in collaboration with Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, Patient Safety, and external vendors. Lead or co-author study synopses, protocols, protocol amendments, informed consent forms, pharmacy manuals and other study manuals, ensuring appropriate cross-functional and Medical Director input. Drive day-to-day study conduct and operational alignment, including study planning, timeline management, identification of risks and dependencies, and timely escalation of issues that may affect quality or delivery.

Act as the clinical science lead for routine site, investigator, coordinator and vendor questions, in collaboration with Clinical Operations; escalate matters requiring medical judgment or formal medical oversight to the Medical Director. Serve as the protocol expert and provide scientific interpretation of protocol requirements, endpoint definitions and study procedures to internal teams, vendors and study sites. Lead ongoing review of emerging study data, data-cleaning strategy, listings and query review, protocol deviations, endpoint data and scientific trends;

identify quality or interpretability issues and coordinate their resolution. Partner with Biostatistics and Data Management on data-review plans, database milestones, interim data cuts and database lock readiness, and ensure that clinical-science review is completed according to agreed timelines. Provide oversight of clinical science activities performed by external vendors, including data review, protocol-deviation assessment, site-question management and preparation of clinical-science deliverables,…