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, as well as several earlier stage assets. 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.

Purpose/Summary: The person serves as a lead for the group of regional Clinical Trial Managers as well as a region’s lead and expert on complex clinical development trial(s).

The person secures expeditious country-level set-up, start, enrolment, compliance and audit readiness – by partnering directly with sites and our trial CROs and by ensuring adequate performance of regional CTMs and supervision.

Essential Functions:

• Coordinates and leads the rCTM team on a trial level
• Leading by example and mentoring other rCTMs, including employee development through company goal setting, performance management processes
• Serves as a core member of the Clinical Trial Team and secure that the region US/CA, EU, LatAm and/or AsiaPac (to which they cover) perspective is considered in relevant aspects of the global set-up and management of the trial(s)
• Contributes to the review of key regional documents (e.g. FDA/IRB, CTA/EC or other regulatory submission packages, country/site ICF, and others) to support expeditious operational site set-up
• Reviewing EC/IRB submission responses and facilitate quick feedback
• Secures the Ironwood partnership to the Regional/Country CRO team, act as their primary point of contact at Ironwood
• Key Ironwood partner to the trial sites, particularly with the Clinical Research Coordinator staff (e.g. study coordinators/nurses, pharmacists, contracts managers, nutritionists, etc.)
• Supporting in set-up and monitoring of Regional/Country site milestones and metrics, including Key Performance Indicators (KPIs) and Key Risk Indicators (KRIs)
• Coordinates a team of rCTMs in the review of Regional/Country site milestones and metrics, including Key Performance Indicators (KPIs) and Key Risk Indicators (KRIs)
• Actively monitors protocol deviations of Regional/Country sites and addresses/escalates potential risks and issues.
• In alignment with study Medical Lead, can coordinate a team of rCTMs in monitoring and assessment of protocol deviations to address/escalate potential risks and issues
• Works with Quality and Medical Lead to ensure sites audit inspection readiness
• Collaborates and drives team to develop and implement contingencies for risk mitigation.
• Identifies opportunities to accelerate trial start-up activities and collaborates with the team on developing actions around these opportunities.
• Participates in Site Selection Visits and leads Ironwood assessment, securing input from other relevant functions as needed.
• Participating in Site Initiation Visits and monitoring visits (as needed).
• Participating in protocol development and master/local ICF process (reviewer)
• Providing line management, if requested
• Other duties as assigned

Prerequisite Education, Experience, & Skills:

• Bachelor’s degree with 10 years of pharmaceutical/Biotech clinical development experience.
• The ideal candidate has very broad experience in site monitoring
• Must have significant experience managing regional/country aspects of activities in Global clinical trials, oversight of CROs and vendors
• Advantageous to have rare disease trial experience
• Proven ability to effectively collaborate with a large group of interdisciplinary teams and Vendors
• Strong proficiency in GCP/ICH and regulatory issues is essential
• Approximately 20% travel may be required