LEAD Clinical Development Scientist External Innovation and New Product Development

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 companys success. Join us on our journey towards sustainable growth creating real impact on patients and society!

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WHAT - Summary & Purpose of the Position

Ipsen is seeking an experienced LEAD Clinical Development Scientist to join our team as we continue to advance our clinical development programs in this position you will be an integral part of the clinical development team directly involved in external innovation/business development activities. 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.

WHAT - Main Responsibilities & Technical Competencies

• Support the VP External Innovation and New Product Development Oncology to provide scientific and clinical leadership in the assessment of external partnering opportunities
• As agreed with the VP External Innovation and New Product Development Oncology lead the assessment and presentation of new opportunities within the team at Ipsen governance and lead/participate in the end-to-end process of partnering including due diligence as appropriate
• Review analyze and interpret emerging pre-clinical and clinical trial data (including biomarkers clinical pharmacology efficacy and safety data) of new external projects under evaluation; make clear data led recommendations on the potential clinical value of the project to patients and Ipsen
• Develop robust clinical development plans for potential new assets to support overarching evaluation of the respective opportunities
• Partner with the wider Global Partnering & External Innovation (GPEI) team to co-create compelling evaluations to present proposals to Governance e.g. Deal Review Board Portfolio Review BoD as required
• As part of the assessment process partner effectively with other key functions including but not limited to Clinical Operations Regulatory Affairs Research & Development Commercial Medical Affairs Biostatistics etc
• Leads and/or participate in clinical dev/medical affairs advisory boards external expert interactions and external activities relevant to the role as appropriate
• Supports the integration of new assets within Ipsen as appropriate
• Remain up to date with current information on pharmaceutical regulations guidelines and practices and therapeutic area knowledge and ensure consistent best practice across all activities indication specific and geographical particularities
• Contribute to the development of presentations abstracts and publications emerging from clinical studies as appropriate
• Ensure compliance of all activities with ICH/GCP guidelines applicable regulatory requirements and Ipsen SOPs
• Support the development and execution of the clinical strategy for assigned Ipsen assets(s) relevant to external innovation role as appropriate
• Other duties as assigned

HOW - Behavioural Competencies Required

HOW - Knowledge & Experience

Education / Certifications:

• Advanced degree in life sciences MSc PharmD. PhD in Clinical/Molecular Medicine/Human Biology and/or related disciplines highly valued

Experience:

• 10 years of clinical development experience in industry ideally both in big Pharma and in Biotech. A minimum of 7 years in Oncology is essential
• 5 years clinical development experience as a Clinical Development Scientist in Oncology with hands-on experience in the design and execution of clinical trials.
• Regulatory Experience (i.e. submission of INDs CTAs registration dossiers) across major jurisdictions (e.g. FDA EMA etc.) is a plus
• Strongly desired: Experience in Business Development of 3 years
• Experience with the analysis and review of clinical data(safety PK PD efficacy) either internal or external.

Languages:

• English: professional fluency. For non-native English speakers a minimum of a certified C1 Level is required.
• French: (i.e. intermediate level: B1 or above) would be advantageous.
• Other languages will be a plus.

Key Inter-personal competencies:

• Strong attention to detail and organizational skills.
• Ability to build strong relationships and work effectively with cross-functional team.
• Cross-cultural awareness demonstrated ability to work in multinational environment
• Excellent verbal written interpersonal and influencing communication skills
• Ability to prioritise and delegate work