Director Clinical Science

Director Clinical Science

Daiichi Sankyo Europe

Multiple Locations, Europe

The Position:

In this role, the team member oversees/key contributor to a global Ph1, 2 or Ph3 trial. Leads clinical study protocol preparation and amendments. Contributes to the medical monitoring and study strategy and to regulatory documents. Collaborates as team member with AROs/CROs. Drafts development plans and sections of submission documents. Provides medical and/or scientific direction to the study team. Partners with Clinical Operations for a successfully delivery of the study. Represents Clinical Science on Project Teams.

Roles and responsibilities:

Study Strategy:

  • Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC, ed-it 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; Leads protocol development and 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 degree in Life Science or Pharmacy or equivalent, PhD/PharmD or equivalent is a plus;
  • Postgraduate training in oncology or clinical research is a plus;
  • 3+ years of relevant clinical experience in industry with PhD, PharmD or 5+ years of relevant clinical experience in industry with Master’s degree;
  • Strategic Thinking;
  • Clinical Trials Knowledge;
  • Scientific and Oncology Knowledge;
  • Influencing Skills;
  • Scientific Knowledge;
  • Drug Development;
  • Critical Thinking;
  • Efficient communications;
  • Problem solving;
  • Strong Team Player;
  • Team Leadership;
  • Ability to travel up to 30% globally.

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