Lead Clinical Development Director, Rare (Remote)IPSEN

Ipsen est un groupe biopharmaceutique mondial de taille moyenne, spécialisé dans les médicaments transformateurs dans trois aires thérapeutiques : l'oncologie, les maladies rares et les neurosciences. Forts de près de 100 ans d'expérience en développement, avec des Hubs mondiaux aux États-Unis, en France et au Royaume-Uni, nous focalisons nos efforts là où les besoins médicaux non satisfaits sont importants, grâce à la recherche et à l'innovation.

Nos équipes passionnées, présentes dans plus de 40 pays, se concentrent sur l'essentiel et s'efforcent chaque jour d'apporter des médicaments aux patients dans 88 pays. Nous construisons un environnement de travail qui met en avant un leadership centré sur l'humain et favorise une culture de collaboration, d'excellence et d'impact. Au sein d'Ipsen, chaque individu est encouragé à être soi-même, à grandir et à s'épanouir aux côtés du succès de l'entreprise. Rejoignez-nous dans notre démarche vers une croissance durable, en créant un impact réel sur les patients et la société.

Pour plus d'informations, visitez notre site web à l'adresse https://www.ipsen.com et suivez nos dernières actualités sur LinkedIn et Instagram.

Core Remit of Activities Internal to Therapeutic Area Development (approx. 65%):

• Support in all clinical matters both Project Teams and drug development programs from lead compound identification to product registration and launch
• Provide clinical, scientific and strategic expertise, contribute to and/or prepare CDP and clinical trial related documents, including but not limited to Investigator Brochure, communication with regulatory authorities, clinical trial synopses, clinical trial protocols, clinical summaries, Clinical Study Report, with the support of other R&D functions and in line with IDP
• Ensure execution of CDP and establish where necessary cross functional alignment to support execution of CDP
• Make final decisions on clinical matters for clinical study teams, supporting clinical operations to achieve clinical team objectives and execution of clinical programs.
• Work on complex issues where analysis of situations or data requires an in-depth knowledge of relevant programs and therapeutic area.
• Act as a resource for clinical study teams and relevant project teams, contribute to the development of key documents (for example TPP, IDP, KPIs). Ensure budgets and schedules meet corporate requirements.
• Regularly interact with major internal and external stakeholders (KOLs Investigators, experts). Interactions frequently involve utilization of key communication skills and clinical expertise, such as negotiating with customers or management or influencing senior level leaders within and outside of Research and Development regarding matters of significance to the organization
• Support the conduct of clinical trials as part of the Clinical Study Team and interfacing with medical CRO representatives
• Contribute to clinical monitoring to ensure data integrity and coherence of data interpretation under the guidance of Target Patient Profile (TP) and IDP
• Contribute to and review scientific communication (abstracts, articles, presentations for internal and external purposes) of Ipsen sponsored studies
• Establish and maintain professional relationships with external medical experts and key thought leaders and to represent Ipsen R&D Oncology TA at investigator meetings, advisory boards, scientific conference or alike

Core Remit of Activities External to Therapeutic Area Development (approx. 35%):

• Proactively liaise with pre-clinical, early development, as appropriate to ensure scientific and medical integrity of IDP, TPP etc
• As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects within the oncology area.
• Liaise with key internal experts as required to support pre-clinical programs and Project Teams for most efficient development of new chemical entities.
• Liaise with Pre-clinical, Early Clinical Development and Clinical Pharmacology department to provide medical expertise as needed for ongoing programs and possible new external assets (up to and including proof-of-concept studies)
• Liaise as medical expert with External Innovation and business development teams to optimize the due diligence activities

General duties/responsibilities:

• Comply with Ipsen's SOPs, GCP, governmental policies, regulations, statutory guidelines and applicable laws regulating drug development and clinical research
• Develop and maintain state of the art scientific, medical and managerial knowledge by:

- Establishing and maintaining an external professional network

- Reading pertinent

scientific and medical publications

- Attending pertinent training courses, workshops, conferences etc.

• Commit to support transformation and change management of R&D division with a focus on high performance culture, data quality, timeliness and budget control accounts
• Assume tasks within the context of team performance and project progress in an objective-driven, solution and results oriented manner with an overall can-do attitude
• Be a proactive member and contributor to Ipsen's medical community