Responsable Faisabilité Opérations de Développement
Amgen Inc
Boulogne-Billancourt, Ile de France
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L’ENTREPRISE :

Pionnier dans le domaine des biotechnologies, le laboratoire pharmaceutique AMGEN est devenu la plus importante entreprise biotech indépendante du marché.

Recherche et Développement étant ses maîtres mots, l’entreprise met au point les traitements les plus innovants, afin d’améliorer de façon significative, la qualité de vie des patients atteints de pathologies lourdes et invalidantes.

Fondé aux Etats-Unis en 1980, Amgen est aujourd’hui présent dans le monde entier. Nos collaborateurs sont la première richesse d’Amgen, par conséquent, nous privilégions des profils diversifiés, pour qui, l’innovation, la performance et l’engagement, sont des valeurs primordiales.

Notre pipeline riche et ambitieux nous permet de nous rapprocher toujours plus de l’excellence. La prise de risques et de décisions, font partie intégrante de nos objectifs.

Forte de son dynamisme et de sa taille humaine, la filiale française, née dans les années 1990, a su s’imposer et obtenir le statut de première filiale européenne en termes de chiffre d’affaires.

Aujourd’hui, Amgen France continue d’évoluer et réalise de belles performances grâce aux solides relations qu’elle est parvenue à établir avec les chercheurs et les médecins français.

LA MISSION :

Develop and sustain the local investigator landscape in line with the Global Development portfolio to support strategic global study design and excellence in clinical trial delivery.

ACTIVITES :

  • Engage internally and externally to identify potential new investigators and maintain knowledge of current investigators in alignment with clinical development plans
  • In collaboration with local functional teams develop repository of site intelligence information (Country Landscaping) to support operational delivery (eg, site capabilities and performance)
  • Establish relationships with potential investigator sites and internal experts to develop and maintain understanding of local treatment paradigms to support clinical trial delivery in line with pipeline development
  • Engage with local cluster teams to identify potential reference sites in support of local input into study design decisions.
  • Maintain relationships with approved reference sites to ensure engagement in study design optimization activities when requested by Development Design Center
  • Collaborate internally and externally to build understanding of local outreach and patient referral pathway knowledge to support global and local study operational delivery tactics (patient recruitment and in support of study design and execution
  • Develop and maintain knowledge of external local clinical trial environment and assess developments for impact on study design and execution
  • Partner with Development Operations Director to provide local country landscaping data for inclusion in CDP and study design decisions
  • Engage with local reference sites to obtain input on study design (Study Design Optimization) as requested by Development Operations Director
  • Collaborate with Development Operations Director and Data & Analytics Senior Manager or Manager to analyse the collated local feedback for incorporation into study design and operational planning decisions
  • Support country study operating reviews to monitor predictability to study operational plans and to inform refinements required to local site intelligence data
  • Utilise site intelligence to develop strategy for study-level operational planning in collaboration with local cross-functional teams to ensure development of a robust operational plan in support of validation of country commitment for a study.
  • Oversee integration of new sites as operational clinical sites (i.e. supporting development of relationship between site and operations team)
  • Ensure consistency of activities and development of best practices through leadership / participation in Development Feasibility Manager forum
  • PROFIL :

    Qualification / Experience :

  • Bachelor’s degree; degree in medical or life science field
  • At least 8 years experience in life sciences or medically related field
  • At least 6 years of clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company
  • Strong understanding of the local health care environment
  • Established relationships with the local health care community across a variety of therapeutic areas and specialties
  • Connaissances :

  • Fluent in spoken / written English
  • Knowledge of local country and international clinical trial management (including regulations & guidelines)
  • Approachable and trustworthy, builds constructive and effective relationships
  • Strong written and oral communication skills
  • Presents confidently in a variety of settings, adjusting to audience and bringing message across
  • Communicates proactively to keep internal and external stakeholders updated
  • Ability to work effectively across teams and on multiple projects
  • Effective in influencing within and operating through a complex global cross-functional matrix
  • Effective stakeholder management skills across functions, regions and cultures
  • Demonstrated ability to work independently
  • Robust analytical ability
  • CONTRAT et LIEU DE TRAVAIL : Contrat à durée déterminée jusqu’au 31 / 12 / 2018, Localisation : Boulogne-Billancourt

    Engagée en faveur de l’intégration des Travailleurs Handicapés, tous nos postes leur sont ouverts. Amgen est aujourd’hui fière de se revendiquer entreprise Handi-

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