Senior Manager, Clinical Scientist
hace 5 días
col-wideJob Description:
Passion for Innovation. Compassion for Patients.
With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.
In Europe, we focus on two areas : The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life.
In Oncology, we strive to become a global pharma innovator with competitive advantage, creating novel therapies for people with cancer.
Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.
We are seeking highly qualified candidates to fill the position Senior Manager, Clinical Scientist (m / f / x).
This role could be filled either in Munich or in one of Daiichi Sankyo's European country locations, office based or remote.
Senior Manager, Clinical Scientist (m / f / x)
The Position :
Oversees typically a single non-pivotal trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document.
Collaborates as team member with AROs / CROs. Drafts development plans, protocol profiles, and sections of submission documents under guidance of higher level.
Reviews and oversee completion of clinical trial protocols. Provides medical and / or scientific direction to Clinical Operations.
Represents Clinical Development on Project Teams.
Roles & Responsibilities :
Study Strategy : Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan;
Reviews patient population and protocol compliance for consistency with study strategy; Develops biomarker strategy in collaboration with Translational Medicine / Clin Pharm;
May act as Clinical study leader (CSL)
Study Planning and Execution : Provides input on major milestones of trial, clinical trial plan and contingency planning;
Analyzes and updates management on potential risks to study deliverables; Provides input on ICF creation; Oversees recruitment and retention;
establishes and implements contingency plans for shortfalls; Consults & recruits members for DSMB and / or adjudication committee setup
Study outputs : Draft responses to IRBs and Health Authorities; Collaborates with Translational Medicine and Clinical Pharmacology to ensure appropriate biomarker, PK / PD measurements;
Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment with Delivery Lead e.
g. review Tables / Listings / Graphs before database lock and quality check of data; Works with BD&O to ensure SAP update
External collaboration : Consults with internal experts and external KOLs, Ad Boards for protocol development; Provides input on CRO / ARO Statement of Work and Budget;
Establishes effective communication between CRO / vendors / ARO
Additional non-study related activities : Occasional senior management interactions at FIHC, WDC; Initiates contact w / KOL and prepares material for KOL interactions on a program based need;
Involvement with in-licensing and acquisitions on individual due diligence activities
Education & Professional Experience :
Master's Degree or equivalent preferred or
PharmD or equivalent preferred or
PhD or equivalent preferred
Postgraduate training in TA or related specialty, or equivalent preferred
4 or More Years with PharmD, PhD and relevant clinical experience preferred
7 or More Years with Master's degree and relevant clinical experience preferred
Ability to travel up to 30% In-house office position that may require travel (global)
Why work with us?
Working at Daiichi Sankyo is more than just a job it is your chance to make a difference and change patients' lives for the better.
We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity.
Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.
#J-18808-Ljbffr
-
Senior Clinical Scientist
hace 2 semanas
Oña, España Almirall A tiempo completoMission• The Senior Clinical Development Scientist is an important member of the Global Project Team, Strategic Clinical Team and Clinical Study Teams working cross functionally with other R&D and non-R&D departments such as Regulatory and Patient Safety, Disease Biology, Global Market Access and Pricing, Medical affairs, Marketing, Market Companies and...
-
Clinical Development Physician
hace 2 semanas
Oña, España Almirall A tiempo completoMissionClinical Development Physician is an important part of Global Study Teams within Global Clinical Development.Provides medical input and support to the study team for a given clinical development project in line within defined clinical development strategy, Target Product Profile (TPP) and target labelling, in collaboration with the cross functional...
-
Adme & Dmpk Senior Scientist
hace 2 semanas
Oña, España Almirall A tiempo completoMissionBe a member of R&D project teams to provide expert ADME&DMPK support across a project lifecycle in a multidisciplinary environment with special focus between the early stages of drug discovery through candidate nomination and early clinical development.Ensure that ADME profiling, PK/PD, M&S, human dose predictions or other related deliverables are...
-
Senior Manager Statistical Programming
hace 5 días
Oña, España Jr Spain A tiempo completocol-wideJob Description:Passion for Innovation. Compassion for Patients.With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.In Europe, we focus on two areas : The goal of our...
-
Project Manager Senior
hace 1 día
Oña, España Oxigent A tiempo completo¿Te interesaría seguir desarrollándote como **Project Manager** en una empresa líder del sector Logístico que se encuentra en plena transformación tecnológica?Desde Oxigent Technologies seleccionamos un/a** PROJECT MANAGER SENIOR** para participar en la gestión de un proyecto económico financiero de la Compañía, ubicado en la zona de **Girona**.En...
-
Senior Business Development Manager For Belgium Market
hace 3 semanas
Oña, España Multisafepay Bv A tiempo completoAbout MultiSafepay MultiSafepay is the leading payment service provider providing omnichannel and advanced payment solutions to businesses across Europe. We are innovative and fast growing, building powerful solutions that transform the way our clients do business. We focus on true solutions to their challenges and are always looking ahead.In short, a true...
-
Senior Business Development Manager For Belgium Market
hace 2 semanas
Oña, España Multisafepay Bv A tiempo completoAbout MultiSafepayMultiSafepay is the leading payment service provider providing omnichannel and advanced payment solutions to businesses across Europe. We are innovative and fast growing, building powerful solutions that transform the way our clients do business. We focus on true solutions to their challenges and are always looking ahead.In short, a true...
-
Senior Business Development Manager For Belgium Market
hace 2 semanas
Oña, España Multisafepay Bv A tiempo completoAbout MultiSafepayMultiSafepay is the leading payment service provider providing omnichannel and advanced payment solutions to businesses across Europe. We are innovative and fast growing, building powerful solutions that transform the way our clients do business. We focus on true solutions to their challenges and are always looking ahead.In short, a true...
-
Oña, España Multisafepay Bv A tiempo completoAbout MultiSafepay MultiSafepay is the leading payment service provider providing omnichannel and advanced payment solutions to businesses across Europe. We are innovative and fast growing, building powerful solutions that transform the way our clients do business. We focus on true solutions to their challenges and are always looking ahead.In short, a true...
-
Oña, España Jr Spain A tiempo completocol-wideJob Description:Job Summary Cluster Manager – Debt Management Services – Consumer/Senior Cluster Manager – Debt Management Services – ConsumerJob Purpose This position is open with Bajaj Finance ltd.Job Duties & Key Responsibilities Duties and Responsibilities – Review and understand existing Unsecured Products processes to identify...
-
R&D Senior Scientist Emerging Diseases
hace 1 mes
Oña, España Zoetis A tiempo completoSeleccioamos científico/a sénior para nuestro departamento de investigación para nuestro centro en Vall de Bianya (Garrotxa, Girona). Tu objetivo será participar en programas de I+D para el registro de vacunas de Zoetis (a nivel global o regional) dentro del grupo de Investigación y Enfermedades Emergentes y planificar, ejecutar y dirigir proyectos o...
-
Project Manager Senior
hace 2 semanas
Oña, España Seidor A tiempo completoHumanizando la Tecnología.Somos una gran empresa con alma de Start-up.Nos organizamos por unidades de conocimiento expertas que colaboran entre sí.Por ello buscamos personas inquietas, que les motiven los retos y con ganas de crecer personal y profesionalmente, que se unan a nuestro equipo para tener un impacto positivo en el mundo a través de la...
-
Beach Club Manager
hace 2 semanas
Oña, España Mett Hotel & Beach Resort 5* A tiempo completoEmpresas: METT Hotel & Beach Resort 5* METT Hotel & Beach Resort in Marbella - Estepona is seeking a dynamic and experienced Beach Club Manager to oversee the daily operations of our exclusive beach club. The Beach Club Manager will be responsible for ensuring a high level of guest satisfaction, managing staff, maintaining the facilities, and coordinating...
-
Senior Fund Accountant
hace 2 semanas
Oña, España Fundcraft Holdco S.Ar.L A tiempo completoAbout fundcraft: Join the exciting journey at fundcraft, where we're revolutionizing the fund industry providing digital-native fund operations.Our mission is clear: to be our client's digital native partner, providing simple, transparent and integrated fund operations empowering alternative investment managers to focus on their core business.As a fully...
-
Beach Club Manager
hace 2 semanas
Oña, España Mett Hotel & Beach Resort 5* A tiempo completo.Empresas: METT Hotel & Beach Resort 5METT Hotel & Beach Resort in Marbella - Estepona is seeking a dynamic and experienced Beach Club Manager to oversee the daily operations of our exclusive beach club. The Beach Club Manager will be responsible for ensuring a high level of guest satisfaction, managing staff, maintaining the facilities, and coordinating...
-
Beach Club Manager
hace 2 semanas
Oña, España Mett Hotel & Beach Resort 5* A tiempo completoEmpresas: METT Hotel & Beach Resort 5METT Hotel & Beach Resort in Marbella - Estepona is seeking a dynamic and experienced Beach Club Manager to oversee the daily operations of our exclusive beach club. The Beach Club Manager will be responsible for ensuring a high level of guest satisfaction, managing staff, maintaining the facilities, and coordinating...
-
Executive Assistant
hace 1 mes
Oña, España Fundcraft Holdco S.Ar.L A tiempo completoJob summary Executive Assistant & Office Manager role at fundcraftManage day-to-day business activities of the C-SuiteOversee office operations and coordinate office procedures Job seniority: entry level Responsibilities • Organize and coordinate the C-Suite's daily calendar• Manage and arrange travel for the C-Suite• Track C-Suite's expenses and...
-
Senior Scientist
hace 2 semanas
Oña, España Almirall A tiempo completoMissionAlmirall is a global pharmaceutical company with a focus on Medical Dermatology.Our goal is to develop novel therapeutics to tackle unmet medical need in the fields of immune inflammatory skin diseases, rare skin diseases and non-melanoma skin cancers.We are seeking a talented cellular immunologist to join our Molecular and Cell Biology (MCB) team...
-
Administration Manager
hace 2 semanas
Oña, España Hays A tiempo completo.About The RoleAs a Fund Administration Manager, you will work in a client-centric team of bright and motivated individuals. Together with your team, you will support prestigious clients in the alternative investment fund industry in their day-to-day operations through fundcraft's proprietary platform. In your position, you will be responsible for ensuring...
-
Export Manager
hace 1 mes
Oña, España Hays A tiempo completo**Tu nueva empresa**Importante empresa dedicada al sector cárnico con gran proyección de crecimiento y reconocida a nível nacional e internacional.**Tu nuevo puesto**- Comercial Senior con más de 10 años de experiência en la exportación de carne fresca y congelada de bovino y ovino a Europa y otros mercados.**Qué necesitarás para encajar con el...
