Clinical Country & Site Lead

Clinical Country & Site Lead

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Job Description

As the Clinical Country & Site Lead (CCSL), you will provide global teams with detailed local operational and scientific knowledge that will advise the overall clinical development strategy and ensure that local opportunities and needs are thoughtfully coordinated into operational plans.

Youwill alsoprovide operational direction and prioritize activities for CCA resources to provide a point of contact for Investigators, affiliate office staff, CRO staff, and Global Clinical Operations (GCO) teams to deliver local clinical trial quality and oversight of CRO activities, with focus on performance.

The Clinical Country & Site Lead 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.

• 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 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 specialist for the provision of country level therapeutic area, disease area, and program and study information to drive and support global operational strategy.
• Participate in 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)
• Serve as the main contact for all GCO clinical studies, leading interactions or advising 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.
• 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 partners. (e.g. investigator assessment of (and feedback on) programs and protocols)
• Act as Lead CCL as required. This includes but is not limited to membership on SMT(s) and GCO Program Teams, 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.
• Support special projects or other GCO activities as a representative of CCM or US.

Qualifications

• Bachelor’s degree with a science/education background required;Advanced degree preferred
• 7+ 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 high scientific/clinical knowledge across key therapeutic areas enabling CCL to discuss compound, development plans, and protocol endpoints with investigator site personnel
• 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
• Strong communication skills, including English language skill in countries where English is not the primary language. Ability to assimilate new knowledge rapidly
• Proven track record to handle a high volume of tasks of varying complexity within a given timeframe and in consideration of relative priorities
• Be customer focused, with excellent leadership, interpersonal skills, cultural awareness, high emotional intelligence and collaborative decision-making approach.

• Experience with study start ups
• Experience withClinical Trial Equity and Access
• Recruiting underserved populations experience
• Currently residing in Central/South US (Texas, Missouri, etc)

Additional Information

Biogen is excited to add depth to their Clinical Country and Site Management team (CCSM). The Clinical Country and Site Lead (CCSL) will provide global teams with detailed local operational and scientific knowledge that will advise the overall clinical development strategy and ensure that local opportunities and needs are thoughtfully coordinated into operational plans.

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.

All your information will be kept confidential according to EEO guidelines.