Associate Clinical Country Lead

  • Full-time
  • Region: US
  • Department: Research & Development

Job Description

     The Associate Clinical Country Lead (in close collaboration with or as a direct report of the CCL, Sr. CCL or Regional Head) 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 ACCL role may be asked to provide operational direction and prioritize activities for local 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 a country level focus on performance.

     ACCLs 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.  

 

The Clinical Country Lead has the following responsibilities:

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

-         Maintain current awareness/information pertaining to local/US 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.

-         Country level Biogen contact participating in the execution of country activities related to the required sponsor oversight of CRO and clinical trial activities (e.g. SOV’s, audits, and inspection support)

-         Country level Biogen contact for assigned GCO clinical studies, leading interactions or directing 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. 

-         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)

-         Support special projects or other GCO activities as a representative of CCM or US CCM as directed

Qualifications

-         B.A or B.S., science background and education

-         5 years experience of managing clinical trial activities, especially sponsor oversight activities in an outsourced model with CROs/vendors.

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

-         Must have leadership skills ready to be developed, 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

-         Strong communication skills, including English language skill in countries where English is not the primary language. Ability to assimilate new knowledge rapidly

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

-         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

Additional Information

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