Head, Clinical Science, Oncology TA

Title: Head, Clinical Science, Oncology TA Company: Ipsen Biopharmaceuticals Inc. 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.

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Job Description: Ipsen is seeking an experienced Group Head, Oncology Clinical Sciences to join our team as we continue to advance our clinical development programs in oncology. In this position, the candidate will be responsible for managing and leading the clinical development scientists in Oncology, harmonizing ways of working, providing senior clinical development expertise into all clinical trials conduct, and elevating the standards of operations.

In addition, the ideal candidate will partner with the SVP, Global Head, Oncology R&D in order to ensure the entire Oncology Therapeutic Area has a consistent clinical development approach when it comes to deliver the oncology portfolio, both in terms of ways of working, inter-departmental relationships, as well as resource allocation, continued education, and talent management. Line manager, mentor and leader of the Clinical Development Scientists in the Oncology TA, both in early- as well as in late-stage development.

Ambassador of the clinical science function and advocate of their career growth and development. More specifically: Performance Evaluation: Establish performance metrics and benchmarks for clinical staff.

Support department leadership in conducting regular evaluations and providing constructive feedback to enhance individual and team performance. Support and advise the SVP Global Head, Oncology R&D, in the strategic and operational planning of the department that aligns with the organization mission and objectives i.e. activities associated with clinical trial execution to the deliver the portfolio, including but to limited to resource allocation, standardization of data review and interpretation, document(s) preparation; as well as with continued education of the oncology staff.

Provide leadership and oversight across early- and late-stage oncology to the review, analysis and interpretation of clinical trial data (including biomarkers, clinical pharmacology, efficacy and safety data) of clinical studies (both early- and late), providing perspective to the individual contributors, e.g. critical review of protocols, CSRs, publications, as well as methodology in clinical data review. Partner effectively with other functions, namely Clinical Operations, Data Management, Medical Writing, and Regulatory Affairs in the day-to-day activities of clinical trial conduct and execution, e.g. site selection, eCRF build, protocol/IB/IND writing, standards for clinical data review.

More specifically: Data Management: Collaborate with the data management team to establish SOPs in data capture systems and ensure the accuracy, integrity, and completeness of clinical trial data for Oncology. Budget and Resource Management: Collaborate with the clinical operation team to effectively manage clinical research budgets and resources, optimizing efficiency while maintaining high-quality standards.

Risk Management: Identify potential risks and challenges in clinical trials and develop risk mitigation strategies to ensure successful trial outcomes. Quality Assurance: In partnership with QA, suggest the implementation of quality control measures to monitor trial conduct and data integrity and ensure compliance with internal policies and external regulations.

Provide guidance, seniority, and leadership to the formation, conduct, and liaison with the data monitoring/steering committees and investigator meetings for all oncology projects. Critically review the development of presentations, abstracts, and publications emerging from clinical studies Serve, as required, as the lead, i.e. with minimal supervision (unless medical topics are to be addressed), clinical development representative for regulatory submissions of high priority late-stage assets, commensurate to the experience acquired of the incumbent in Oncology late development.

Ensure compliance of all activities with ICH/GCP guidelines, applicable regulatory requirements, and Ipsen SOPs Education / Certifications: Bachelor’s degree in Health Sciences or nursing qualifications (e.g. B.ScN, RN) Additional advanced degrees in Health Sciences such as MSc, PhD, PharmD will be valued Experience: 15+ years of clinical development experience in the pharmaceutical industry, ideally in mid-sized/big organizations (mostly), so that to be able to apply, translate, and export those experiences and ideas to the Ipsen ecosystem.

A minimum of 10 years in Oncology would be highly desirable. 10+ years clinical development experience as a Clinical Development Scientist, either as an individual contributor and/or line manager of clinical scientists, with hands-on experience in the design and execution of clinical trials, preferably in Oncology. 5+ years of management experience, inclusive of other clinical scientists. Management experience includes experience in resource allocation, performance evaluation, and talent management.

Experience with the analysis and review of clinical data (safety, PK, PD, efficacy), either internal or external. Regulatory Experience (i.e. submission of INDs, CTAs, registration dossiers) across major jurisdictions (e.g.

FDA, EMA, etc.) is a big plus Expertise in clinical data review tools, such as RAVE, J-Review, Spotfire; and any other data review platforms or advanced software We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities.

When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve.

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