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Director Clinical Science

vor 4 Monaten

München, Deutschland Daiichi Sankyo Europe GmbH Vollzeit

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 clinical science team based in Europe we are seeking highly qualified candidates to fill the position

Director Clinical Science (m/f/x)

This global role could be filled Europe-wide, in one of the Daiichi Sankyo offices locations

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 successful delivery of the study. Represents Clinical Science on Project Teams.


Aufgaben
  • 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

Profil
  • 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

Wir bieten
  • Excellent Benefits
  • Work-Life Balance
  • Growth and Development
  • Health and Wellbeing Support

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