Senior Clinical Development Scientist

Ipsen; Paris; On-site; EUR 90,000 - 130,000; Full time

Job summary

Ipsen seeks a clinical development professional in Paris to support and/or co-lead the clinical strategy for Ipsen assets, working with the clinical development, regulatory, data management, and statistics teams.

You will review trial data, prepare for investigator meetings and steering committees, and contribute to regulatory documents while ensuring adherence to ICH/GCP guidelines and Ipsen SOPs. The role emphasizes leadership, collaboration, and staying abreast of therapeutic area trends.

Qualifications

• Strong communication skills
• Attention to detail
• Ability to thrive independently in a fast-paced environment
• Experience in clinical development and execution of trials

Responsibilities

• Support and/or co-lead the clinical strategy development and execution for Ipsen assets.
• Review, analyze, and interpret emerging trial data and prepare for key study meetings.
• Partner with clinical leads, CROs, and internal teams for oversight of trial activities.
• Contribute to authoring protocol, ICF, study manuals, and briefing books.
• Ensure compliance with ICH/GCP guidelines and Ipsen SOPs.

Job description

In this position, you will be an integral part of the clinical development team supporting the execution of clinical studies. The ideal candidate will have strong communication skills, attention to detail, and the ability to thrive independently in a highly innovative and fast-paced environment. Support and/or co-lead the development and execution of the clinical strategy for assigned Ipsen assets(s).

• Support and/or co-lead with the assigned Clinical Development Directors (medically qualified) the clinical team of an assigned project and provide scientific and clinical leadership in planning, conducting, and executing clinical trials including review of clinical study documents, reports, data review and interpretation of the trials generated data for future use in next studies/programs
• Review, analyze, and interpret emerging clinical trial data (including biomarkers, clinical pharmacology, and safety data) and lead preparation for key study meetings (e.g. investigator meetings, monitoring committees, advisory boards)
• Partner with the study clinical lead/CRO medical monitor on oversight of clinical trial activities, including safety reviews and site/CRO interactions
• Liaise with the broader clinical development team (clinical operations, data management, statistics/programming, and regulatory teams)
• Contribute to authoring key study and regulatory documents (e.g. protocol, ICF, study manuals, briefing books)
• Lead and/or participate in internal meetings to review topics from clinical development perspective and develop mitigation plans
• Leads and/or participates in clinical dev/medical affairs advisory boards, data monitoring/steering committees and investigator meetings.
• Remains up to date with current information on pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities, indication specifics and geographic areas particularities.
• Contribute to the development of presentations, abstracts, and publications emerging from clinical studies
• Ensure compliance of all activities with ICH/GCP guidelines, applicable regulatory requirements, and Ipsen SOPs

May participate as required in external innovation/business development activities, providing clinical/scientific expertise in technical evaluations, with supervision of the VP Oncology Clinical Development.