Medical Director for Cardiovascular Therapies
hace 4 semanas
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 Europe, we focus on two areas: protecting people from cardiovascular disease, the leading cause of death in Europe, and helping patients who suffer from it to enjoy every precious moment of life. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries and Canada.
Job DescriptionThe successful candidate will oversee typically a single non-pivotal trial (small size, standard complexity in design and geographic scope). They will prepare the clinical section of regulatory documents and collaborate with AROs/CROs as part of the team. Additionally, they will draft development plans, protocol profiles, and sections of submission documents under guidance of higher-level staff. The Medical Director will review and oversee the completion of clinical trial protocols, provide medical and/or scientific direction to Clinical Operations, and represent Clinical Development on Project Teams.
Responsibilities- Study Strategy: Provide strategic direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan. Review patient population and protocol compliance for consistency with study strategy. Develop biomarker strategy in collaboration with Translational Medicine/Clinical Pharmacology. Act as Clinical Study Leader (CSL) when necessary.
- Study Planning and Execution: Provide input on major milestones of trials, clinical trial plan, and contingency planning. Analyze and update management on potential risks to study deliverables. Provide input on ICF creation. Oversee recruitment and retention. Establish and implement contingency plans for shortfalls. Consult and recruit members for DSMB and/or adjudication committee setup.
- Study Outputs: Draft responses to IRBs and Health Authorities. Collaborate with Translational Medicine and Clinical Pharmacology to ensure appropriate biomarker, PK/PD measurements. Review emerging clinical data regularly. Lead dose-escalation meetings. Perform quality assessment with Delivery Lead (e.g., review Tables/Listings/Graphs before database lock and quality check of data). Work with BD&O to ensure SAP update.
- External Collaboration: Consult with internal experts and external KOLs, Ad Boards for protocol development. Provide input on CRO/ARO Statement of Work and Budget. Establish effective communication between CRO/vendors/ARO.
- Addition non-study-related activities: Occasional senior management interactions at FIHC/WDC. Initiate contact with KOLs and prepare material for KOL interactions on a program-based need. Involve with in-licensing and acquisitions on individual due diligence activities.
- 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 global travel.
We offer an estimated annual salary of €80,000 - €110,000 depending on experience, location, and other factors.
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