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.
Position Overview: The Head of Clinical Operations will lead and will be accountable for the global clinical operations team responsible for the Apraglutide development program and oversee activities for Ironwood portfolio assets. This role ensures the successful planning and execution of clinical trials within timelines, quality standards, and budget. Reporting to the Senior Vice President of Research and Development, the Head of Clinical Operations will spearhead operational excellence and oversee adherence to regulatory requirements and company SOPs while managing both internal and external resources for clinical trial activities.
Key Responsibilities:
- Lead and grow a high-performing global development operations team, overseeing hiring, development, and training.
- Represent Clinical Operations on the Apraglutide Development Leadership Team, contributing to drug development strategy and planning.
- Provide actionable insights for clinical development programs, including timelines, enrollment models, and patient population assessments.
- Oversee the development and implementation of study plans, enrollment projections, site feasibility, and risk mitigation strategies.
- Ensure clinical studies are executed on time, within budget, and meet quality standards (ICH/GCP, Global Regulations).
- Manage cross-functional study/program costs and financial updates.
- Build collaborative relationships with internal and external stakeholders.
- Maintain inspection readiness for Clinical Programs and act as an expert during regulatory inspections.
- Manage the clinical operations budget for all development programs.
Qualifications:
- BA/BS in life sciences, PhD, PharmD, DVM or MD
- 10+ years of experience in pharmaceutical, biotechnology, or CRO environments leading global clinical trials (Phase 1 to Phase 3 and post-marketing).
- In-depth knowledge of GCP and ICH guidelines, FDA, and EMA regulations.
- Proven leadership skills in a global clinical environment.
- Experience with contract negotiation, management, and clinical operations budgeting.
- Ability to work independently and collaboratively in a fast-paced environment.
- Willingness to travel domestically and internationally as needed
- Experience with rare diseases/orphan drugs and or Gastrointestinal/nutrition therapeutic area is preferred
- Proven track record of bringing assets through the clinical phases, including developing a clinical strategy for early and later stage programs, designing clinical trials, and managing clinical data quality.
Skills and Competencies:
- Strong leadership and team management skills.
- Excellent communication and interpersonal skills.
- Strategic thinking and problem-solving abilities.
- Ability to build and maintain strong relationships with internal and external stakeholders.
- High level of organizational and project management skills.
Location:
- This position is based in Basel-Stadt, Switzerland.
- Flexible hybrid working arrangement, minimum in-office presence 1 day/week
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