Senior clinical development director h/f

En tant qu'organisateur de forums de recrutement, Talents Handicap accompagne de très nombreuses entreprises & organisations en France dans leurs recrutements de collaborateurs en situation de handicap. Participant actuellement à l'un de nos forums. L'entreprise IPSEN Pharma recherche actuellement des profils : Ipsen est un groupe biopharmaceutique mondial spécialisé dans le développement de médicaments innovants en oncologie, en neurosciences et dans les maladies rares.
Fondé à Dreux (Eure et Loir) en 1929, Ipsen a une présence importance en France avec son hub mondial à Paris, regroupant le siège social, la filiale commerciale française, et les activités de recherche et développement, ainsi qu'un site de développement pharmaceutique à Dreux (Eure-et-Loir) et un site de production à Signes (Var).
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.

JOB DESCRIPTION

Position

Job Title: Director, Clinical Development, Rare Diseases Therapeutic Area

Division / Function: Rare Diseases Therapeutic Area (RDTA), Global R&D

Manager (Name, Job Title): Sr Director, Odevixibat Clinical Development Lead

Location: This is a remote role; however, if local to an R&D hub (Cambridge, MA; London, UK; Paris, FR), the candidate will have the option to come into the office as desired

Summary / purpose of the position

We are looking for a Director, Clinical Development 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 expectations

Main Responsibilities

Main Tasks

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.
- Provide study leadership and collaborate with cross-functional team members across the lifecycle of the study (i.e., design, execution, interpretation, and communication).
- Serve as medical monitor for clinical trials and to ensure adherence to ICH GCP, patient safety, and data integrity, in close collaboration with the CRO medical monitor.
- Provide medical expertise for interactions with regulatory authorities, including required regulatory documentation and responses to questions from global regulatory agencies.
- Build and maintain strong relationships with clinical investigators and thought leaders.
- Effectively fosters productive and collegial working relationships in a cross-functional, matrix environment with internal and external stakeholders.

Knowledge, abilities & experience

- Advanced scientific degree (MD [or equivalent], PhD or PharmD).
- 5+ years of clinical research and/or drug development experience within the pharmaceutical industry, a CRO, or similar organization.
- Experience in designing and conducting Phase I-III clinical trials and providing medical expertise for regulatory submissions such as IND/CTA/NDA/MAA.
- Pediatric hepatology expertise preferred.

Key Technical Competencies Required

- Objective-driven, solution and results oriented, with a solid sense of urgency.
- Ability to thrive in a fast-paced and dynamic environment.
- Excellent verbal, written, and interpersonal communication skills.
- Ability to lead teams with diverse backgrounds to deliver results.
- Demonstrated ability to work cooperatively within and outside the organization to accomplish the best outcomes for Ipsen.

The annual base salary range for this position is $255,000 - $306,000.

This job is eligible to participate in our short-term incentives program.

At Ipsen we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more.

The pay range displayed above is the range of base pay compensation within which Ipsen expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills.