Senior Clinical Development Scientist

Title:

Senior Clinical Development Scientist

Company:

Ipsen Pharma (SAS)

 

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation.

 Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.

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.

Nous nous engageons à créer un lieu de travail où chacun se sent écouté, valorisé et soutenu, où nous incarnons « The Real Us*». La valeur que nous accordons aux différentes perspectives et expériences motive notre engagement en faveur de l'inclusion et de l'égalité des chances. Lorsque nous intégrons des modes de pensée diversifiés, nous prenons des décisions plus réfléchies et découvrons des solutions plus innovantes. Ensemble, nous nous efforçons de mieux comprendre les communautés que nous servons. Cela signifie que nous voulons également vous aider à donner le meilleur de vous-même lorsque vous postulez à un poste chez nous. Si vous avez besoin d'aménagements ou d'aide pendant le processus de candidature, veuillez en informer l'équipe de recrutement. Ces informations seront traitées avec soin et n'auront aucune incidence sur le résultat de votre candidature. *Soyons nous-même