Head, Clinical Science, Oncology TA

Responsibilities

• 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.
• Partner with the SVP, Global Head, Oncology R&D, in the strategic and operational planning of the department that aligns with the organization mission and objectives.
• Ensure the entire Oncology Therapeutic Area has a consistent clinical development approach when it comes to delivering 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.
• 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).
• 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.
• 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.

Qualifications

• 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.