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 Leadwill 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 Leadrole 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 Leadwill 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 DoMaintain 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 PlanProvide 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 CSOactivities related to a given program or trial.
(30-50% if serving in the role, depending on phase of programPrimary 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 milestonesLead 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 resourcesSupport special projects or other QSDO activities as a representative of CSOor CountryQualificationsRequired 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 personnelRequires strong organizational skills and leadership skills, especially project management skills, with an ability to set clear goals, align priorities and lead multiple tasks/activitiesIdeal 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 remotelyProven ability to handle a high volume of tasks of varying complexity within a given timeframe and in consideration of relative prioritiesAdditional InformationAt 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.
Read on to learn more about our DE&I efforts.
•
PL - Kraków
July 13, 2024
Pracodawca: • Artroskop Centrum Medyczne Bogdan Wziętek « Powrót Dermatolog Miejsce pracy: • Trzebinia Region: • małopolskie Specjalizacja: • Dermatologia i wenerologia Pracodawca: • Artroskop Centrum Medyczne Bogdan Wziętek Poszukujemy Dermatologa do prywatnej przychodni na...
PL - Warszawa
June 27, 2024
Our Client, who's building an International Financial IT Hub, is looking for a Senior JVM Software Engineer. • The Client is covering tech needs in securities services, global banking, and IT production. • The team is responsible for the synchronization of settlements data between various...
PL - Warszawa
July 10, 2024
HybridThe Backend department uses modern and innovative technologies to create our world-leading cybersecurity products. • We have squads that work towards different goals, but we are mainly known as driven professionals writing quality code.Main ResponsibilitiesWrite clear, tested, documented...
PL - Wrocław
July 13, 2024
Our project portfolio is growing and so is our development team.Currently, Spyrosoft is building a Development Center for a new Client - leading open source API platform, enabling worldwide developers and business users to build, manage and monitor their APIs.We are looking for experienced Senior...
PL - Poznań
July 15, 2024
Job Summary: • Our Client, a global manufacturing company, is looking for an experienced Operations Director who can successfully drive the further development of an employee-oriented high-performance culture. • The role emphasizes a continuous improvement mindset with a focus on...
PL - Warszawa
June 27, 2024
About you • We are looking for someone who will is a whizz with Python, has experience with microservices and is happy to get stuck into a gritty and fast paced environment to work within our awesome Python team, championing and leading the build of secure, robust and high-performance systems....
PL - Kraków
July 16, 2024
Technical Consulting Engineer - Next Generation FirewallLocation: • Krakow, PolandArea of Interest: • SecurityJob Type: • ProfessionalJob Id: • 1425657What You'll Do: • Be a trusted technical authority to global Cisco customers and partners.Work with customers via...
United Parcel Service of America
PL - Ożarowice
July 16, 2024
Opis stanowiska: • Asystent Agenta Celnego w Exporciemiejsce pracy: • Pyrzowice/Mysłowice/hybrydowa/zdalnaGłówne zadania: • obsługa klientów oraz przewoźników w zakresie spraw celnych i realizacji przesyłek spedycji lotniczej oraz drogowej,współpraca z klientem krajowym i...
PL - Gdańsk
June 23, 2024
Das Stellenangebot • Als Mitarbeiterin oder Mitarbeiter unseres Kinderintensivpflegedienstes Paulchen begleitest du Kinder in ihrem häuslichen Umfeld. Du unterstützt die Familie und die Kinder dabei, ein möglichst unbeschwertes Leben zu führen. • Weiterhin sind für die ausgeschriebene...
PL - Warszawa
July 6, 2024
Poland - Warsaw | Senior Client DirectorMetrixLab is a fast-growing global market research and insights company that's challenging the status quo of insights. • By blending evolving technology with passionate experts, MetrixLab helps global and local brands to drive more impact, and forges...
PL - Kraków
July 13, 2024
Hello! We're the Ads Interface Team , a group of people making waves in Nordic advertising.We develop the Admarket platform , where advertisers can book their campaigns directly by themselves to be displayed on top sites in Sweden and Norway. • Our goal is to provide the best possible...
PL - Zabrze
June 27, 2024
Dyrektor Oddziału - Niezależny Partner Biznesowy Gliwice, śląskie Dyrektor Oddziału - Niezależny Partner Biznesowy Zabrze Zabrze, śląskie, Polska Dyrektor Oddziału - Niezależny Partner Biznesowy Twój zakres obowiązków Prowadzenie działalności gospodarczej przez cały okres trwania umowy...
PL - Kraków
June 27, 2024
Dyrektor Agencji Kraków, Lesser Poland Voivodeship Dyrektor Agencji Kraków Kraków, Małopolskie, Polska Twój zakres obowiązkówprowadzenie własnego biznesu opartego na zarządzaniu zespołem sprzedaży,rekrutacja i wdrożenie nowych Konsultantów ds. • Planowania Finansowego oraz Menedżerów,budowanie...
PL - Warszawa
June 27, 2024
As a Staff ML Research Lead you will work on challenging ML projects that extend and improve the way ML is used in our company. • ML is at the very center of RTB House, and you will have a strong, immediate impact on our core metrics. • We are looking for a strong technical leader that...
PL - Sieradz
June 27, 2024
Dyrektor Oddziału - Niezależny Partner Biznesowy Sieradz, łódzkie Dyrektor Oddziału - Niezależny Partner Biznesowy Sieradz Sieradz, łódzkie, Polska Dyrektor Oddziału - Niezależny Partner Biznesowy Twój zakres obowiązków Prowadzenie działalności gospodarczej przez cały okres trwania umowy...
PL - Chorzów
July 10, 2024
: • Mechanical Lead Engineer ElectricalDate: • 9 Jul 2024Company: • Alstom Leading societies to a low carbon future, Alstom develops and markets mobility solutions that provide the sustainable foundations for the future of transportation. • Our product portfolio ranges from...
PL - Kraków
June 27, 2024
Sharing the costs of foreign language classesSharing the costs of professional training & coursesVideo gamesCoffee/teaCorporate products and services at discounted pricesSharing the commuting costsEmployee referral programCharity initativesFamily picnicsTake your next career step at ABB with a...
Ernst and Young Advisory Services Sdn Bhd
PL - Warszawa
June 27, 2024
Technology Consulting team works with some of the world's best-known large domestic and global financial institutions, broker-dealers, foreign banking organizations, asset management and insurance companies. • These organizations trust us to assist them in adressing large scale transformation...