Medical Development Director, Elafibranor

il y a 1 jour

BoulogneBillancourt, France IPSEN Temps plein

**Title**:
Medical Development Director, Elafibranor

**Company**:
Ipsen Bioscience, Inc.

**Main Responsibilities**

**Core Remit of Activities Internal to Therapeutic Area Development**
- Support in all medical, scientific, strategic, and clinical matters for rare liver disease drug development programs from lead compound identification to product registration and launch
- Supports the Senior MDD in any rare liver disease activities, including clinical reviewer for due diligence activities for future assets
- Ensures from a medical perspective compliance with GCP, ethical, scientific, and medical guidelines and statutory principles throughout all clinical development activities
- Participates with TA Head and other senior cross-functional leaders in establishing strategic plans and objectives for rare liver disease portfolio.
- Contributes to and review scientific communication (abstracts, articles, presentations for internal and external purposes) of Ipsen sponsored studies
- Works closely with the CRO Medical Monitor, provide medical oversight for all clinical trials
- Maintains close communication with the data monitoring committee or independent review committee providing oversight to the quarterly safety reviews as well all safety alerts and endpoint adjudication
- Works closely with the Clinical Scientist assigned to projects
- Provide medical, scientific, and strategic expertise, contribute to and/or prepare CDP and clinical trial related documents, including but not limited to Investigator Brochure updates, communication with regulatory authorities, clinical trial amendments, clinical summaries, Clinical Study Reports, with the support of other R&D functions and in line with IASP
- Contribute to medical monitoring to ensure data integrity and coherence of data interpretation under the guidance of Target Patient Profile (TP) and IASP
- 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 Rare Disease TA at investigator meetings, advisory boards, scientific conference etc.
- Advises the Senior MDD and Global Asset Lead on critical issues deserving immediate attention and escalation, proposing actionable solutions.

**Core Remit of Activities External to Therapeutic Area Development (a**
- As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects within the Rare Disease area
- Liaise with key internal experts to support pre-clinical programs including biomarker development
- Liaise with Early Clinical Development platform and Clinical Pharmacology department to provide medical expertise to Early Development programs (up to and including proof-of-concept studies)

**General duties and 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

**Knowledge, abilities & experience**
- Medical degree (e.g., MD, MBChB or foreign equivalent)
- At least two years of pharmaceutical industry experience in clinical development with preference for rare disease drug development
- Clinical experience or board eligible/certification a plus
- Expertise in clinical development, pediatric clinical development and real-world evidence generation is highly preferred
- Understanding of US and European regulatory requirements and processes for product testing and approval
- Experience preparing for and presenting at US and European regulatory meetings such as Pre-IND, End-of-Phase 2, etc. preferred.
- In-depth knowledge of clinical protocol design, evaluation, and conduct
- Experience in the preparation and submissions of INDs, NDAs, and/or international registration dossiers
- Demonstrated ability to design and execute clinical development
- Experience in analyzing, interpreting, and reporting scientific results of clinical studies

**Key Technical Competencies Required**
- Objective-driven, solution and results oriented, with a solid sense of urgency
- Excels in working in matrix organizations and project teams
- Excellent priority setting

  • Medical Development Director, Rare Disease

    Il y a 7 mois

    Boulogne-Billancourt, France Ipsen Bioscience, Inc. Temps plein

    We are looking for a Medical Director in the Rare Diseases Therapeutic Area to join our Clinical Development team. The Medical Development Director will provide medical guidance and leadership in the design, implementation, monitoring and interpretation of our clinical development programs in rare liver diseases. **Main responsibilities / job...

  • Early Development Project Management Director

    Il y a 7 mois

    Boulogne-Billancourt, France Ipsen Innovation (SAS) Temps plein

    **Summary / purpose of the position** The Early development Project Management Director will be part of the Research & External Innovation organization and will report to the VP early portfolio strategy & operations. The Early development Project Management Director will: - Contribute to drive successful operational execution of early development programs...

  • Gma Director Rare Diseases

    il y a 12 heures

    Boulogne-Billancourt, France IPSEN Temps plein

    **Title**: GMA Director Rare Diseases **Company**: Ipsen Pharma (SAS) Ipsen is advancing with highly promising developments in Rare Liver Diseases (lead indication: Primary Biliary Cholangitis (PBC)). As part of the rare diseases team, the GMA Director will act as the Medical Affairs Asset Lead to ensure strategic design and operational excellence in...

  • Senior Medical Director, Aesthetic Medical Lead

    Il y a 3 mois

    Boulogne-Billancourt, France Ipsen Pharma (SAS) Temps plein

    **Position** Job Title**:Senior Medical Director, Aesthetic Medical Lead** Division / Function**:CMO, Global Medical Affairs, Neuroscience** Manager (Name, Job Title)**:Dr Hamzah Baig, VP GMA Neuroscience** Location**:UK (London), France (Boulogne-Billancourt), USA (Cambridge, MA)** **Summary / purpose of the position** **The Aesthetic Medical Lead is...

  • Senior Medical Director, Aesthetic Medical Lead

    il y a 3 semaines

    Boulogne-Billancourt, France Ipsen Pharma (SAS) Temps plein

    **Position** Job Title**:Senior Medical Director, Aesthetic Medical Lead** Division / Function**:CMO, Global Medical Affairs, Neuroscience** Location**:UK (London), France (Boulogne-Billancourt), USA (Cambridge, MA)** **Summary / purpose of the position** **The Aesthetic Medical Lead is responsible for the Aesthetic Medical Strategy and optimal...

  • Global Medical Affairs Director Rare Diseases

    Il y a 2 mois

    Boulogne-Billancourt, France Ipsen Pharma (SAS) Temps plein

    Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly improving patients’ health and quality of life and providing them with effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in...

  • Senior Medical Director, External Innovation and

    Il y a 3 mois

    Boulogne-Billancourt, France Ipsen Pharma (SAS) Temps plein

    **Are you ready to lead and innovate in a dynamic, patient-focused biopharmaceutical company?** Ipsen is a growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly improving patients’ health and quality of life, providing effective therapeutic solutions for...

  • Therapeutic Area Director, Global Medical Clinical

    Il y a 3 mois

    Boulogne-Billancourt, France Ipsen Pharma (SAS) Temps plein

    Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly improving patients’ health and quality of life and providing them with effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in...

  • Global Aesthetic Injector Academy Medical Director

    Il y a 3 mois

    Boulogne-Billancourt, France Ipsen Pharma (SAS) Temps plein

    **Position** Job Title**:Global Aesthetic Injector Academy Medical Director - Neuroscience** Division / Function**: Global Medical Affairs, Neuroscience** Manager (Name, Job Title)**: Dr Hamzah Baig, VP GMA Neuroscience** Location**:UK (London), France (Boulogne-Billancourt), USA (Cambridge, MA)** **Summary / purpose of the position** **Lead and...

  • Global Aesthetic Injector Academy Medical Director

    il y a 3 semaines

    Boulogne-Billancourt, France Ipsen Pharma (SAS) Temps plein

    **Position** Job Title**:Global Aesthetic Injector Academy Medical Director - Neuroscience** Division / Function**: Global Medical Affairs, Neuroscience** Location**:UK (London), France (Boulogne-Billancourt), USA (Cambridge, MA)** **Summary / purpose of the position** **Lead and continuously improve a Global offering on advanced Toxin Injector training...

  • Stage Global Medical Education

    il y a 12 heures

    Boulogne-Billancourt, France IPSEN Temps plein

    **Title**: Stage Global Medical Education H/F **Company**: Ipsen Pharma (SAS) **To assist the Global Medical Education and Scientific Engagement Director** in the development of a global medical education strategy, and plan/execute adapted medical education activities in the assigned indication within the rare disease therapeutic area.** **Main...

  • Global Clinical Development Director Rare Disease

    Il y a 5 mois

    Boulogne-Billancourt, France Ipsen Bioscience, Inc. Temps plein

    **Core Remit of Activities Internal to Therapeutic Area Development (approx. 75%)** - Provide medical expertise and leadership in the design and implementation of clinical development strategies aligned with company objectives. - Lead the development of clinical trial protocols, ensuring scientific rigor and compliance with global regulatory requirements. -...

  • Senior Medical Director, Medical Asset Lead

    Il y a 4 mois

    Boulogne-Billancourt, France Ipsen Pharma (SAS) Temps plein

    Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly improving patients’ health and quality of life and providing them with effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in...

  • Strategy Director

    Il y a 7 mois

    Boulogne-Billancourt, France Skaleet Temps plein

    As Strategy Director, you will be a member of our Leadership team and will report to the Chief Strategy Officer. You will play a key role in defining and implementing our short term objectives as well as preparing our mid to long-term plans. You will work closely with the ExCo team as well as other VPs/Directors to lead or contribute to high impact and value...

  • Strategy and Transformation Director

    il y a 12 heures

    Boulogne-Billancourt, France IPSEN Temps plein

    **Title**: Strategy and Transformation Director **Company**: Ipsen Pharma (SAS) **The Global Strategy and Transformation Directors support Ipsen Management in the definition of the Group strategy. They lead strategic & transformation projects and orchestrate the Group’s long-term strategic plans across Ipsen divisions and functions.**: **Main job...

  • Director, Global Strategic Insights

    Il y a 7 mois

    Boulogne-Billancourt, France Ipsen Pharma (SAS) Temps plein

    **Summary / purpose of the position** This is a newly created role within Strategic Business Excellence (SBE) and specifically the Decision Support Team. The Director, Global Strategic Insights & Forecasting - New assets/indications role will provide strategy and business insights to core members of the Global brand teams and Global Asset Teams that are to...

  • Global Porfolio Development Project Leader Chc

    il y a 12 heures

    Boulogne-Billancourt, France IPSEN Temps plein

    **Title**: Global Porfolio Development Project Leader CHC **Company**: Ipsen Consumer Healthcare SAS Division / Function: Global Strategic Operations Consumer HealthCare - Portfolio Development Manager : Global Portfolio Development Director CHC Location: Boulogne-Billancourt, France **Summary / purpose of the position** Ipsen Consumer HealthCare is...

  • Medical Communication Manager

    Il y a 8 mois

    Boulogne-Billancourt, France Novocure Temps plein

    Novocure is a global publicly-traded commercial-stage oncology company developing a profoundly different cancer treatment therapy called tumor treating fields (TTFields) for patients with solid tumors. TTFields therapy is a non-invasive, novel, antimitotic treatment modality which utilizes proprietary technology attempting to slow or reverse tumor...

  • Sr. Director External Innovation, Oncology

    Il y a 7 mois

    Boulogne-Billancourt, France Ipsen Bioscience, Inc. Temps plein

    As Director/Sr Director, External Innovation - Oncology, you will play a leadership role in IPSEN’s External Innovation group, spearheading efforts to identify, evaluate, and secure Oncology external opportunities (pre-clinical and clinical stage as well as marketed therapeutic assets). It is expected that these efforts will provide direct and visible...

  • Director of Sales and Business Development for Data Center and Energy Solutions

    il y a 4 jours

    Boulogne-Billancourt, Île-de-France European Tech Recruit Temps plein

    Job Overview: European Tech Recruit is seeking a highly experienced Sales Director to lead our sales efforts in the European market, focusing on Data Center and Energy solutions. As a seasoned professional with a proven track record, you will be responsible for driving business growth, identifying new opportunities, and building strong relationships with key...