Lead Clinical Development Director, Rare

This is a fully remote position, open to applicants in France, +1 more country.

📋 Description

• Assist Project Teams and drug development initiatives on clinical issues from the identification of lead compounds to product registration and launch.

• Provide clinical, scientific, and strategic insights and prepare or contribute to clinical development and trial-related documents.

• Ensure the implementation of Clinical Development Plans and foster cross-functional collaboration.

• Make final clinical decisions for study teams and support clinical operations in achieving program goals.

• Serve as a resource for clinical study and project teams, contributing to essential documents such as TPP, IDP, and KPIs.

• Ensure that budgets and timelines align with corporate standards.

• Engage with internal and external stakeholders, including KOLs, investigators, and experts.

• Support clinical trials as part of the Clinical Study Team and collaborate with medical CRO representatives.

• Contribute to clinical monitoring, ensuring data integrity and coherent data analysis.

• Assist in the development and review of scientific communications, including abstracts, articles, and presentations.

• Establish connections with external medical experts and thought leaders, representing Ipsen R&D Oncology at investigator meetings, advisory boards, and scientific conferences.

• Coordinate with pre-clinical, early development, and clinical pharmacology teams to uphold scientific and medical integrity.

• Engage in competitive intelligence and market or industry evaluation activities.

• Provide medical expertise to back pre-clinical programs, Project Teams, and potential external assets.

• Assist with due diligence activities alongside External Innovation and business development teams.

• Adhere to Ipsen SOPs, GCP, regulations, and applicable laws.

• Facilitate R&D transformation and change management and contribute to Ipsen’s medical community.

⛳️ Requirements

• Expertise in clinical development throughout the lifecycle from lead compound identification to product registration and launch.

• Comprehensive understanding of relevant clinical programs and therapeutic areas.

• Proficiency in the development of clinical trials, protocols, clinical summaries, Clinical Study Reports, and related documents.

• Experience with Clinical Development Plans (CDP), Target Patient Profiles (TPP), Integrated Development Plans (IDP), and KPIs.

• Knowledge of clinical operations, clinical monitoring, data integrity, and data analysis.

• Ability to engage with KOLs, investigators, medical experts, and senior internal and external stakeholders.

• Experience in supporting clinical trials and collaborating with medical CRO representatives.

• Familiarity with regulatory authorities, GCP, SOPs, governmental policies, regulations, statutory guidelines, and applicable laws governing drug development and clinical research.

• Scientific, medical, and managerial knowledge maintained through publications, training, workshops, and conferences.

• Capability to support pre-clinical, early clinical development, clinical pharmacology, external innovation, and business development efforts.

• Ability to perform or contribute to competitive intelligence and market/industry assessments.

• Competence to work in a proactive, objective-driven, solution-oriented, and results-focused manner.

• Dedication to transformation, change management, high-performance culture, data quality, timeliness, and budget management.

🏝️ Benefits

• Workplace culture centered on human-centric leadership, collaboration, excellence, and impact.

• Empowerment to develop and succeed alongside the company’s growth.

• Commitment to inclusion and equal opportunity.

• Provision for application accommodations and support throughout the recruitment process.