Senior Medical Director, Clinical Development

Ironwood Pharmaceuticals

Pharmazeutische Industrie

4030 Basel, Basel-Stadt - Schweiz

Abteilungsleiter / Manager

Experteer Overview

In this senior leadership role, you drive clinical development strategies for assigned assets, collaborating with cross-functional teams to design, execute, and interpret trials. You will oversee medical monitoring, study documents, and regulatory interactions to advance the development plan. You will lead external collaborations, engage with regulators, and mentor teams to ensure data quality and patient safety. This position offers high visibility and impact on Ironwood’s clinical development trajectory in GI and rare disease indications.

Verantwortungsbereiche

Lead clinical development activities for trial design, execution, and interpretation
Develop and guide the Clinical Development Plan (CDP) and cross-functional strategies
Prepare key study documents (protocols, amendments, SAPs, clinical study reports, regulatory filings)
Oversee trial execution and medical monitoring to ensure data quality and subject safety
Assess results and adjust development strategy communicated to management
Coordinate external research collaborations and investigator-initiated studies
Support regulatory interactions and submissions (DSUR, INDSRs)
Provide scientific education and act as therapeutic-area expert to investigators and cross-functional teams
Represent Ironwood at external meetings and with regulatory bodies
Oversee vendor activities including CROs

Zentrale Anforderungen

PhD/MD/PharmD (or equivalent) with 8+ years in clinical drug development
Proven experience in design, conduct, and data analysis of registration-track global trials
Strong background in rare disease trials; industry-sponsored trial experience preferred
Extensive knowledge of regulatory requirements and trial documentation
Experience with ethics committee and regulatory interactions
Board-certified (or foreign equivalent) in Gastroenterology, Hepatology, Internal Medicine, or Pediatrics preferred but not required
Excellent written and oral communication skills
Ability to lead cross-functional teams and manage complex projects

leadership influencing and accountability cross-functional collaboration clinical trial design and execution statistical analysis plans and data interpretation regulatory submissions and DSUR/INDs

Stellenbeschreibung

In this senior leadership role, you drive clinical development strategies for assigned assets, collaborating with cross-functional teams to …

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