Lead Clinical Development Director, Rare

Job not on LinkedIn

🔥 1 hour ago

🌐 France, United Kingdom – Remote

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⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 10%

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Logo of Ipsen

Ipsen

5001 - 10000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Ipsen is a global biopharmaceutical group that focuses on improving patient lives through innovative medicines in the areas of oncology, rare diseases, and neuroscience. With a commitment to addressing high unmet medical needs, Ipsen leverages its expertise and resources to develop new therapies and collaborations, accelerating the path from scientific innovation to patient care. The company strives to make a significant impact in the lives of patients suffering from serious conditions such as cancer, rare diseases, and neurological disorders.

📋 Description

• Support Project Teams and drug development programs on clinical matters from lead compound identification through product registration and launch • Provide clinical, scientific and strategic expertise and prepare or contribute to clinical development and trial-related documents • Ensure execution of Clinical Development Plans and establish cross-functional alignment • Make final clinical decisions for clinical study teams and support clinical operations in achieving program objectives • Act as a resource for clinical study and project teams and contribute to key documents such as TPP, IDP and KPIs • Ensure budgets and schedules meet corporate requirements • Interact with internal and external stakeholders, including KOLs, investigators and experts • Support clinical trials as part of the Clinical Study Team and interface with medical CRO representatives • Contribute to clinical monitoring and ensure data integrity and coherent data interpretation • Contribute to and review scientific communications, including abstracts, articles and presentations • Build relationships with external medical experts and thought leaders and represent Ipsen R&D Oncology at investigator meetings, advisory boards and scientific conferences • Liaise with pre-clinical, early development and clinical pharmacology teams to support scientific and medical integrity • Participate in competitive intelligence and market or industry assessment activities • Provide medical expertise to support pre-clinical programs, Project Teams and potential external assets • Support due diligence activities with External Innovation and business development teams • Comply with Ipsen SOPs, GCP, regulations and applicable laws • Support R&D transformation and change management and contribute to Ipsen’s medical community

🎯 Requirements

• Clinical development expertise across the lifecycle from lead compound identification through product registration and launch • In-depth knowledge of relevant clinical programs and therapeutic areas • Expertise in clinical trial development, 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 interpretation • Ability to interact with KOLs, investigators, medical experts and senior internal and external stakeholders • Experience supporting clinical trials and interfacing with medical CRO representatives • Knowledge of regulatory authorities, GCP, SOPs, governmental policies, regulations, statutory guidelines and applicable laws regulating drug development and clinical research • Scientific, medical and managerial knowledge maintained through publications, training, workshops and conferences • Ability to support pre-clinical, early clinical development, clinical pharmacology, external innovation and business development activities • Ability to conduct or contribute to competitive intelligence and market/industry assessments • Ability to work in a proactive, objective-driven, solution- and results-oriented manner • Commitment to transformation, change management, high-performance culture, data quality, timeliness and budget control

🏖️ Benefits

• Workplace culture focused on human-centric leadership, collaboration, excellence and impact • Empowerment to grow and thrive alongside the company’s success • Inclusion and equal-opportunity commitment • Application accommodations and support during the recruitment process

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