Alsi - Rwe & Clinical Operations Director (H/F)

**Descriptif de l'entité et de l'activité**

Avec près de 16 500 collaborateurs, une présence dans 35 pays, un chiffre d’affaires de plus de 3,5 milliards d’euros, Air Liquide Healthcare, la branche Santé du Groupe Air Liquide, est un des leaders mondiaux dans ce domaine.

Aujourd’hui, Air Liquide Healthcare est présent à l’hôpital et au domicile des patients pour y fournir des produits, des services et des programmes d’accompagnement pour la prévention, le diagnostic et le traitement de maladies chroniques ou lors d’épisodes aigus.

**Quelle sera votre contribution et comment vous épanouir dans ce poste ?
Reporting to the Vice President Evidence & Access, the RWE & clinical operations director will contribute to the achievement of the company’s objective by planning, designing & executing RWE studies and clinical trials, ensuring adherence to regulatory guidelines while optimizing operational effectiveness and shaping the future of evidence generation.

The RWE & clinical operations director will be a permanent member of the future Evidence Design committee.
The RWE & clinical operations director will closely collaborate with the HEOR lead as well as with Biometry, Medical Affairs and Market Access, to streamline interactions and responsibilities (interfaces, decision making..) regarding global evidence generation.

**RWE studies & clinical trials planning, design and execution**
- As a member of the Evidence Design committee, propose strategic and pragmatic solutions/ approaches to answer business needs, in line with evidence gaps and stakeholder needs
- Manage and oversee RWE studies and clinical trials across therapies
- Set up and roll out the clinical studies governance (decision making, validation processes,...)
- Set up a process to monitor global activities in clinical research (outside WBL)
- Advice and support countries in developing study protocols and execution

**Operational excellence**
- Drive operational efficiency & streamline processes as needed to ensure operational effectiveness ( ressources, tools,...)
- Optimize collaboration with external partners ( CROs,..) and identify preferred ones
- Manage studies budget and targets
- Train and support end-users

**Quality, regulatory and compliance**
- Embed a study vetting and approval process to safeguard quality
- Ensure scientific rigor and regulatory compliance for all research activities
- Advise and support countries in the best regulatory approaches
- Support quality management activities

**VBHC transformation and smart evidence generation**
- Maintain and develop relevant relationships with key institutions, research groups, CROs, KOLs and other RWE thought-leaders to optimize the impact of RWE research, identify innovative methodologies and continue developing expertises.
- Engage with regulatory bodies and health agencies to unlock challenges and

anticipate future trends.
- Support outcomes collection and research activities for efficient and on-going RWE generation (regulatory framework for the collection of outcomes, opportunities for data registries,...)
- Strongly contribute with the E&A team to further develop a smart evidence generation roadmap

The RWE & clinical operations Director will lead a team of two clinical projects managers and one
regulatory & compliance lead and will be responsible to:

- Provide guidance to the team in their day to day activities
- Maintain and develop the team expertises
- Engage and coach people to success
- Drive and sustain a culture of performance

**Etes-vous LA personne faite pour ce poste ?
At least 8-10 years work experience in healthcare/ Life science in a managing position
- Strong knowledge of the drug and medical device pharmaceutical industry and its corresponding regulations.
- Excellent understanding of RWE and secondary use of data challenges and opportunities.
- Demonstrated skills, knowledge and experience in the successful design and execution of RWE studies and clinical trials
- Demonstrated ability to lead team members in conveying evidence of value and facilitating decision making
- Demonstrated ability to set and execute on priorities, manage multiple projects and produce results.
- Ability to continuously adapt in a rapidly changing atmosphere and to lead teams through times of change to maintain and improve operational excellence.
- Outstanding leadership and interpersonal skills including demonstrated track record developing relationships at all levels in an organization
- Excellent oral and written communication skills
- Excellent English (written and oral)

**Nos différences font notre performance**

Chez Air Liquide, nous nous engageons à créer un environnement de travail collaboratif et inclusif qui reflète la diversité de nos collaborateurs, de nos clients, des patients et de nos parties prenantes ainsi que des cultures à travers le monde.