Senior Manager, Clinical Scientist

hace 2 meses


All, España Daiichi Sankyo Europe A tiempo completo

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 of 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.
The Position:
Oversees typically a single non-pivotal trial (small size, standard complexity in design and geographic scope). Prepares the clinical section of regulatory documents. Collaborates as a team member with AROs/CROs. Drafts development plans, protocol profiles, and sections of submission documents under the guidance of a higher level. Reviews and oversees the 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 with 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;
PharmD or equivalent preferred;
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



  • All, Gerona, España Daiichi Sankyo Europe A tiempo completo

    Senior Manager, Clinical ScientistDaiichi Sankyo Europe seeks a Senior Manager, Clinical Scientist to oversee clinical trials and develop regulatory documents. As a key member of the clinical development team, this individual will provide medical and scientific direction to Clinical Operations and represent the company on Project Teams.


  • All, España Daiichi Sankyo Europe A tiempo completo

    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...


  • All, España Daiichi Sankyo Europe A tiempo completo

    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...


  • All, España Daiichi Sankyo Europe A tiempo completo

    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...

  • Global Oncology HEOR

    hace 6 meses


    All, España Daiichi Sankyo Europe A tiempo completo

    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...


  • All, España Daiichi Sankyo Europe A tiempo completo

    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...


  • All, Gerona, España Daiichi Sankyo Europe A tiempo completo

    OverviewDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative solutions for patients worldwide.Job DescriptionWe are seeking an experienced Data Scientist AI/ML Innovation Lead to join our team in Munich, Germany. The successful candidate will be responsible for managing end-to-end delivery...


  • All, España Daiichi Sankyo Europe A tiempo completo

    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...


  • All, Gerona, España Daiichi Sankyo Europe A tiempo completo

    Job DescriptionWe are seeking a highly qualified Data Scientist to join our team in Munich, Germany. This role will be responsible for managing end-to-end delivery of AI/ML projects, partnering with internal and external stakeholders, and optimizing AI/ML technology and processes.About the RoleThe position holder will have a strong knowledge of AI/ML...


  • All, Gerona, España Daiichi Sankyo Europe A tiempo completo

    OverviewDaiichi Sankyo Europe, a global pharmaceutical company with over 120 years of experience and a presence in more than 20 countries, is seeking an experienced professional to join its team as Senior Manager of Quality Assurance in Pharmacovigilance.


  • All, Gerona, España Daiichi Sankyo Europe A tiempo completo

    OverviewDaiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that enrich the quality of life.Estimated Salary€80,000 - €110,000 per year based on experience and qualifications.Job DescriptionSenior Safety Scientist (m/f/x)This role requires a highly qualified candidate to...


  • All, Gerona, España Daiichi Sankyo Europe A tiempo completo

    About Daiichi Sankyo EuropeDaiichi Sankyo is a leading pharmaceutical company with over 120 years of experience and more than 17,000 employees in over 20 countries. Our mission is to discover, develop, and deliver new standards of care that enrich the quality of life around the world.In Europe, we focus on two areas: cardiovascular disease and oncology. We...


  • All, Gerona, España Daiichi Sankyo Europe A tiempo completo

    Job Description:Daiichi Sankyo Europe is seeking a highly skilled Senior Manager Statistical Programming Expert to provide technical support to project teams on statistical programming deliverables and submissions.Responsibilities:Support project lead on outsourced projects, acting as a statistical programming subject matter expert (SME) to ensure correct...


  • All, España Daiichi Sankyo Europe A tiempo completo

    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...


  • All, Gerona, España Daiichi Sankyo Europe A tiempo completo

    Overview:">Daiichi Sankyo Europe is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments for patients worldwide.We are seeking a highly skilled Senior Safety Scientist to join our team in Munich, Germany, and contribute to the post-marketing surveillance of our oncology products.Job Description:The...


  • All, España Daiichi Sankyo Europe A tiempo completo

    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...


  • All, Gerona, España Daiichi Sankyo Europe A tiempo completo

    Daiichi Sankyo Europe is seeking a highly qualified Medical Director for Cardiovascular Therapies to join our team.About UsWith 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...


  • All, España Daiichi Sankyo Europe A tiempo completo

    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...


  • All, España Daiichi Sankyo Europe A tiempo completo

    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...


  • All, Gerona, España Daiichi Sankyo Europe A tiempo completo

    About UsDaiichi Sankyo Europe is a leading pharmaceutical company with over 120 years of experience and more than 17,000 employees in over 20 countries.Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.We are dedicated to discovering, developing, and delivering new standards of care that enrich the...