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Référence: REQ12454 Date de l'offre: 12/04/2022 Offre consultée 100 fois

Associate Clinical Country and Site Lead

Prise de poste : 12/04/2022 BAC +5 Hauts-de-Seine
Nombre de postes : 1 CDI À négocier
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BIOGEN
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Description du poste et des missions

Through cutting-edge science and medicine, Biogen discovers, develops and delivers innovative therapies worldwide for people living with serious neurological and neurodegenerative diseases. Founded in 1978, Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis. Biogen also manufactures and commercializes biosimilars of advanced biologics. Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options. For more information, please visit www.biogen.com.



About this role



The Associated Clinical Country Lead is a field based country/regionally aligned role, strategically focused on providing key local operational and scientific expertise to drive country and regional level clinical development strategy,  enable local partnerships that enhance customer satisfaction (Internal and external), and support focused delivery and execution of the R&D pipeline. 



What you'll do



     The Associated Clinical Country Lead (ACCSL), in close collaboration with or as a direct report of the CCSL, Sr. CCSL or Regional Head responsible for their country(ies), will provide global teams with detailed local operational and scientific knowledge that will inform the overall clinical development strategy and ensure that local opportunities and needs are thoughtfully integrated into operational plans.



     At the country level, the ACCSL role may be asked to provide operational direction and prioritize activities for local CCSA resources to provide a single point of contact for investigators, affiliate office staff, CRO staff, and GCO/global teams to deliver local clinical trial quality and oversight of CRO activities, with a country level focus on performance.



     The ACCSL will also serve as a site escalation point for investigator concerns, including those related to data integrity or issues which are un-resolved by the CRO, so that these may be communicated to the appropriate Biogen responsible party. 



Key Responsibilities




  • Maintain current awareness/information pertaining to local clinical knowledge of disease areas researched by Biogen, emerging standards of care, and trial related needs of clinicians in community.  Hold specific operational and scientific discussions and act as local GCO expert for the provision of country level therapeutic area, disease area, and program and study information to drive and support global operational strategy. Coordinate cross functional local affiliate input as required to provide appropriate country level input into Clinical Development Plan 

  • Manage investigator and site knowledge/relationships to inform teams of country level capabilities, interests, needs and satisfaction levels.  This would involve the development of a country level GCO investigator engagement strategy, or execution of global strategy (in collaboration with Wolrd medical or local medical) to position Biogen as the company partner of choice for clinical trials. 

  • Lead/support required local activities as part of agreed country and site selection process to ensure appropriate input is sought from local treating physicians and other stakeholders. (e.g. investigator assessment of (and feedback on) programs and protocols) 

  • Primary country level GCO/Biogen contact for all GCO clinical studies, leading interactions or managing CCSA interactions to ensure timely local information flow and resolution of issues as appropriate with Investigators, affiliate office staff, CRO staff, and GCO/global teams.  Understand, analyze and monitor overall Country Performance (KPIs) and support country focused activities to deliver country operational milestones 

  • Primary country level GCO/Biogen contact accountable for strategic development and execution of country activities related to the required sponsor oversight of CRO and clinical trial activities (e.g. SOV’s, audits, and inspection support) 

  • Support local or regional projects or other CCSM activities as a representative of their country



Education and Experience Requirements :




  • Science background and education (B.A or B.Sc)

  • Extensive (min 5 years) experience of managing clinical trial activities, especially sponsor oversight activities in an outsourced model with CROs/vendors.



Essential Skills and Qualifications Required:




  • Deep understanding of cross functional drug development process and high scientific/clinical knowledge across key therapeutic areas enabling CCSL to discuss compound, development plans, and protocol endpoints with investigator site personnel

  • Requires strong organizational skills and leadership skills, especially project management skills, with an ability to set clear goals, align priorities and lead multiple tasks/activities

  • Effective working knowledge of relevant IT tools to promote virtual team working

  • Excellent knowledge of clinical operational activities/challenges across local geography

  • Ideal candidate will be customer focused, with excellent leadership, interpersonal skills, cultural awareness, high emotional intelligence and collaborative decision-making approach. Must build relationships throughout and across the organization whilst operating remotely

  • Proven ability to handle a high volume of tasks of varying complexity within a given timeframe and in consideration of relative priorities

  • Fluent in English 



Why Biogen? 

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.



To apply : please follow this link : https://smrtr.io/8JYZy 

Lieu de la mission

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