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.
For our European headquarters in Munich or in one of our European affiliates we are seeking highly qualified candidates to fill the position :
Director Clinical Development (m / f / x)
The Position :
Roles & Responsibilities : Study Strategy : Clinical study (co) leader (CSL); For large or complex Phase 2 or 3 studies : Provides the strategic direction to BD&O for EDC, edit checks, data quality listings, SAP, DM plan, Reviews patient population and protocol compliance for consistency with study strategy, Develops biomarker strategy in collaboration with TMCP, Collaborates with external KOLs to refine study plans;
Prepares and participate in regulatory agency meetings, if applicable
Study planning and execution : As CSL for Phase 2 or 3 studies : Provides input on major milestones of trial, clinical trial plan and contingency planning, Analyzes, updates management on potential risks to study deliverables, Provides input on ICF creation, Oversees recruitment, retention;establishes and implement contingency plans for shortfalls, Consults & recruits members for DSMB and / or adjudication committee setup;Interacts with KOLs and PIs to plan study and monitor completion
Study outputs : For Phase 2 or 3 studies : Drafts responses to IRBs and HA, Collaborates with TMCP to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Performs quality assessment e.
g. review TLFs before DBL, and quality check of data, Works with BD&O to ensure SAP updates; Responsible for valid clinical interpretation of study results as Clinical Study Leader ormedical monitor
External collaboration : Develops and leads advisory panels to advise on Phase 2 or 3 study strategy, design, and conduct;Consults with internal experts and external KOLs, Ad Boards for protocol development and specific advice; Provides input on CRO / ARO Statement of Work and Budget;Establishes effective communication between CRO / vendors / ARO
Scientific, Program related : Integrated Study Team (IST) representative : Collaborate with cross functional team on the clinical development plan (CDP) and contributes to overall development Strategy;
Contribute to the development of the biomarker strategy; Interprets and react accordingly to new preclinical / clinical data (e.
g. ; Go / No Go decisions, reprioritization, etc.) Additional non-study related activities : Initiates contact w / KOL and prepare material for KOL interactions on a program-based need;
Participate in company-wide and functional initiatives
Professional Experience & Education : Master's Degree or equivalent would be preferredPharmD, PhD or equivalent would be preferredPostgraduate training in TA or related specialty, or equivalent would be preferred5 or More Years with PharmD, PhD and relevant clinical experience7 or More Years with Master's degree and relevant clinical experienceAbility to travel up to 20% - 25%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.
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