Clinical Country Lead
Vicente Lopez, Argentina
hace 3 días

Company Description

At Biogen, our mission is clear : we are pioneers in neuroscience. Since our founding in 1978 as one of the world’s first global biotechnology companies, Biogen has led innovative scientific research with the goal over the last decade to defeat devastating neurological diseases

Job Description

  • This is a field based country / regionally aligned role, strategically focused on providing key local operational and scientific expertise to drive global clinical development strategy, enable local partnerships that enhance global customer satisfaction (Internal and external), and support focused delivery and execution of the R&D pipeline.
  • The CCL 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 CCL role will provide operational direction and prioritize activities for CCA 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 focus on performance.
  • The CCL may also provide direct line management to aCCLs as appropriate.

  • CCLs 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
  • Provide and manage investigator and site knowledge / relationships to highlight 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 WM or local medical) to position Biogen as the company partner of choice for clinical trials.

  • 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)

  • Act as Lead CCL required. This includes but is not limited to membership in CDT and SMT(s), coordinating Program and Study Country Foundation, investigator assessment of (and feedback on) programs and protocols, and Site Selection activities.
  • Also responsible for training CCLs on therapeutic area and program, program and trial level communications, and ownership of CCM activities related to a given program or trial.

  • Primary country level GCO / Biogen contact for all GCO clinical studies, leading interactions or managing CCA 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

  • Lead 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)

  • Provide operational direction for activities of assigned CCA resources
  • Provide direct line management of assigned aCCL resources
  • Support special projects or other GCO activities as a representative of CCM or Country.
  • Qualifications

  • Deep understanding of cross functional drug development process and high scientific / clinical knowledge across key therapeutic areas enabling CCL to discuss compound, development plans, and protocol endpoints with investigator site personnel
  • Requires strong organizational 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
  • Strong communication skills, including English language skill in countries where English is not the primary language. Ability to assimilate new knowledge rapidly.
  • Must have strong leadership skills, with the ability influence and drive performance in colleagues with or without direct line reporting and coordinate across varying cultures and geographies to fulfill global aspects of the role
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