Associate Director, Clinical Scientist at Ironwood Pharmaceuticals

Boston, MAFull-time60700 Clinical DevelopmentPosted about 9 hours ago

About the Role

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:  <ul> <li> 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.</li> <li> 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.</li> <li> 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.</li> <li> 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.</li> <li> Serve as the protocol expert and provide scientific interpretation of protocol requirements, endpoint definitions and study procedures to internal teams, vendors and study sites.</li> <li> 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.</li> <li> 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.</li> <li> 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, in collaboration with Clinical Operations.</li> <li> Represent the function on study management teams and, where assigned, lead cross-functional study subteams or defined workstreams.</li> <li> Develop and deliver disease, protocol and study-specific training for internal colleagues, vendors, investigators, coordinators and study-site personnel.</li> <li> Partner with Regulatory Affairs in the preparation of health authority interactions, including contributing clinical-science content to briefing packages, responses to health authority questions and related meeting materials.</li> <li> Provide clinical and scientific input to clinical regulatory documents, including clinical study reports, investigator's brochures, safety reports, pediatric development plans and submissions to health authorities.</li> <li> Provide clinical and scientific input to final study reports, annual reports, publications, congress materials and internal or external presentations, as assigned.</li> <li> Support advisory boards, investigator meetings, steering committee meetings and partner discussions; represent the company externally when requested and appropriately delegated.</li> <li> Maintain thorough and current knowledge of the relevant disease area, scientific literature, competitor development programs, regulatory requirements and GCP standards, and apply this knowledge to study execution and interpretation.</li> <li> Ensure all assigned activities are conducted in accordance with applicable internal procedures, GxP requirements, legal obligations and ethical standards.</li> <li> Undertake additional clinical-science responsibilities or support other programs as business and organizational needs evolve.</li> </ul> Requirements:  <ul> <li> Academic degree (e.g., BS, BSN) in a relevant scientific or healthcare discipline. Advanced degree (MS, MPH, PhD, PharmD, MD, or equivalent) is strongly preferred.  </li> <li> At least five years of experience in clinical drug development, in an academic or industry setting.</li> <li> Proven experience in the design, conduct, data review and interpretation of clinical trials; rare-disease experience is strongly preferred.</li> <li> Demonstrated ability to lead day-to-day study activities and coordinate complex cross-functional deliverables while maintaining clear accountability, priorities and timelines.</li> <li> Extensive experience authoring and reviewing clinical-trial protocols, amendments, informed consent forms, study manuals and other protocol-related documents.</li> <li> Strong experience with ongoing clinical-data review, data-cleaning processes, listings, protocol deviations, endpoint interpretation, database milestones and study-report development.</li> <li> Knowledge of regulatory and GCP requirements governing clinical trials, with experience supporting ethics committee, health authority or other external-agency interactions.</li> <li> Experience providing oversight to CROs and other external vendors and working in close partnership with Clinical Operations, Biostatistics and Data Management.</li> <li> Demonstrated ability to rapidly gain and leverage disease area and disease biology knowledge, to synthesize scientific literature and competitor information and apply it to development programs.</li> <li> Strong leadership, influencing and problem-solving skills, with the judgment to distinguish routine operational matters from issues requiring medical review or escalation.</li> <li> Highly effective scientific communicator with excellent written, oral and presentation skills, capable of training and aligning diverse internal and external stakeholders.</li> <li> Adaptable, collaborative and accountable team member who can work independently, manage ambiguity and deliver high-quality work to agreed timelines.</li> <li> Fluency in English, with excellent written and verbal communication skills.</li> <li> Willingness and ability to travel domestically and internationally up to 20% and to periodically report to the Basel or Boston office, depending on the role’s location.</li> </ul> Ironwood currently anticipates that the initial base salary for this position could range from between $147,000-$175,000.  The actual base salary will depend, in part, on the successful candidate’s qualifications for the role, including education and experience.  Ironwood offers a comprehensive compensation and benefits program to eligible employees, including Restricted Stock Unit awards; eligibility to participate in either a bonus or sales incentive program; company-sponsored 401(k) with matching contributions; eligibility for medical, dental, vision and prescription drug benefits; wellness stipends; and a generous vacation/holiday schedule.