Clinical Country and Site Lead

6 miesięcy temu

Warsaw, Polska Biogen Pełny etat

Job Description

This is a field-based country 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 the country focused delivery and execution of the R&D pipeline. 

The Clinical Country and Site Lead 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 Clinical Country and Site Lead role will provide operational direction and prioritize activities for CCSA resources to provide a single point of contact for Investigators, affiliate office staff, CRO staff, and QSDO/global teams to deliver local clinical trial quality and relationship oversight of CRO activities, while providing a country level focus on performance.

Clinical Country and 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.

This role is a remote work model. Please note that this role requires a candidate to be a holder of work permit & residency in Poland.

What You’ll Do

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 QSDO 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 QSDO 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 QSDO/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 CCSL 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 CCSLs on therapeutic area and program, program and trial level communications, and ownership of CSO activities related to a given program or trial. [30-50% if serving in the role, depending on phase of program Primary country level QSDO/Biogen contact for all QSDO 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 QSDO/global teams. Understand, analyze and monitor overall Country Performance (KPIs) and support country focused activities to deliver country operational milestones  Lead and manage 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 CCSA resources  Support special projects or other QSDO activities as a representative of CSO or Country

Qualifications

Required skills:

Extensive (7 + years) experience of managing clinical trial activities, especially sponsor oversight activities in an outsourced model with CROs/vendors. Science background and education (B.A or B.S; advanced degree preferred) 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 Strong communication skills, including fluent Polish & English language 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 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

Additional Information

At our newly built, centrally located Warsaw office, our team supports a global organization with dedication and innovation. In this office, where 31 nationalities form our community, we celebrate the strength that comes from differences in backgrounds, experiences, and perspectives. This commitment to fostering a supportive and inclusive workplace has earned us a Great Place to Work Certificate for three consecutivea years and Best Places to Work Awards in both Poland and Europe.

What drives us every day is our unique purpose, working passionately to change the lives of patients affected by rare neurological diseases. If our mission resonates with your heart and career aspirations, join our team.

We eagerly anticipate welcoming you to our dynamic and collaborative environment, where together, we make a meaningful impact on a global scale.

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. to learn more about our DE&I efforts.

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