Director Clinical Development

vor 2 Wochen


Munich, Deutschland Daiichi-Sankyo Europe Vollzeit

Oversees one or more trials of medium to high complexity in design and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; Participates in creation of developmental and regulatory strategy; Drafts protocol profiles and sections of key submission documents; Point of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead.

**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 preferred
- PharmD, PhD or equivalent would be preferred
- Postgraduate training in TA or related specialty, or equivalent would be preferred
- 5 or More Years with PharmD, PhD and relevant clinical experience
- 7 or More Years with Master’s degree and relevant clinical experience
- Ability to travel up to 20% - 25%

**Why work with us?**:



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