Clinical Development Leader for Rare Diseases
vor 1 Monat
Ironwood Pharmaceuticals is a leading global healthcare company dedicated to advancing the treatment of gastrointestinal (GI) diseases and redefining the standard of care for GI patients. As part of VectivBio, we are focused on discovering, developing, and commercializing innovative treatments for severe rare conditions with high unmet medical need.
The Company's lead product candidate, apraglutide, is a next-generation peptide analog in Phase 3 clinical trials for treating patients with short bowel syndrome, a malabsorption disorder caused by the loss of functional small intestine. Additionally, apraglutide is in Phase 2 for acute graft-versus-host disease (GVHD).
We are seeking an experienced Clinical Development Leader for Rare Diseases to join our interdisciplinary development team. This high-visibility leadership role will contribute effectively and independently to clinical development of assigned assets, directly reporting to the Head of Clinical Development, Basel Site.
The successful candidate will integrate clinical and research expertise with leadership skills to advance our clinical development strategy, including supporting regulatory approval. Key responsibilities include representing clinical science in study management teams, training internal and external staff, and responding to health authority requests related to the clinical development plan.
This role requires strong analytical and problem-solving skills, as well as excellent written and oral presentation skills. The ideal candidate will have a deep understanding of clinical research methodology and biostatistics principles, with experience in managing complex projects and influencing diverse stakeholders.
Key Accountabilities:
- Participate in clinical development team activities, contributing to the creation and implementation of clinical development strategies and plans.
- Contribute to study design, conduct, and interpretation, preparing key study documents and ensuring data quality and subject safety.
- Support sponsor oversight of clinical trial execution, assessing the impact of results on the development strategy, and presenting conclusions to management.
- Interact with external stakeholders, including regulatory agencies and sponsors, to ensure seamless collaboration and timely completion of clinical and preclinical research.
Requirements:
- MD degree with at least 5 years of prior clinical development experience in the pharmaceutical industry.
- Board certification in Gastroenterology and/or Hepatology, Internal Diseases, or Pediatrics is preferred, but candidates with other medical specialties and sound clinical research experience will be considered.
- Proven knowledge of clinical research methodology and biostatistics principles, with experience in analyzing and interpreting clinical and efficacy data.
- Demonstrated project management skills, with ability to influence and collaborate with diverse stakeholders.
- Excellent written and oral communication skills.
Salary: $180,000 - $220,000 per annum, depending on location and experience.
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