Director Clinical Development, Clinical Scientist (m/f/x)

Passion for Innovation. Compassion for Patients.

Daiichi Sankyo and its 16,000 employees in more than 20 countries are dedicated to the creation and supply of innovative pharmaceutical products. In Europe, we focus on two areas: In the cardiovascular space, our strong portfolio of medicines reflects our long-standing commitment and shows that we care for every heartbeat; in oncology our goal is to become a global pharma innovator until 2025 by providing novel therapies to patients across the world. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries. For more information: www.daiichi-sankyo.eu.

We are seeking highly qualified candidates to fill the position:

Director Clinical Development, Clinical Scientist (m/f/x)

Job Summary:

The Clinical Scientist (CS) has a key role in the initiation, implementation and execution of clincal study protocols and is part of a cross-function study team to ensure timely execution and completion of the clincal study(ies) which could be pivotal for submissions. This position will support and/or lead activities as related to global registrational Phase 3 studies in Daiichi Sankyo’s oncology development.The CS collaborate as a crossfunctional team member with AROs/CROs, overseeing and ensuring aspects of CRO performance. The CS supports the development of protocol profiles, protocols, protocol amendments, informed consent forms, Investigator Brochure and clinical sections of submission documents. The CS has a key role in the ongoing review of clinical study data, ensuring data integrity and quality and collaborating cross-functionally within DSI study team and with the CRO to adhere to data quality standards and pre-defined study milestone timelines. This role provides medical and/or scientific direction to Clinical Operaions, Statistics and other functions as needed. Under direction of the CS Study Lead, may represent Clinical Development in various governance meetings and strategic discussions within the Project Team.

Responsibilities:

• Study Strategy:
  • Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data quality listings, SAP, Data Mgmt plan
  • Reviews patient population and protocol compliance for consistency with study strategy
  • Support the development of the biomarker strategy in collaboration with Translational Medicine/Clin Pharm
  • May assume responsibility/leadership for certain aspects of the clinical study under direction of the CS Study Lead
• 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
  • Provides input on ICF creation
  • Oversees recruitment and retention
  • establishes and implements contingency plans for shortfalls
  • Consults & recruits members for DSMB and/or adjudication committee set-up
• Study outputs:
  • Draft responses to IRBs and Health Authorities
  • Collaborates with Translational Medicine and Clinical Pharmacology to ensure appropriate biomarker, PK / PD measurements
  • Key role in the ongoing clinical reviews of clinical study data, ensuring high data quality and integrity prior to database locks (e.g. review Tables/Listings/Graphs before database lock and quality check of data)
  • Supports the Study Team Lead with periodic quality assessments
  • 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

Qualifications:

• Master's Degree or equivalent would be preferred
• Postgraduate training in TA or related specialty, or equivalent would be preferred
• 4 or More Years with PharmD, PhD and relevant clinical experience
• 7 or More Years with Master’s degree and relevant clinical experience

Travel Requirements:

Ability to travel up to 30%

This position could be filled either in Germany or in one of the other European countries where Daiichi Sankyo has a subsidiary.

What we offer

Working at Daiichi Sankyo

At Daiichi Sankyo in Europe, we offer a workplace where your voice is heard. Everything we do, we do with a high level of commitment and a clear focus on patients’ needs. We know that our bold ambition to change patients’ lives for the better can only be achieved through the power of collaboration and the exploration of new approaches. Thus, we encourage our colleagues across Europe to be courageous, to bring their ideas to the table and to embrace opportunities to grow. When you join our European family, you will be a part of a dynamic company where everyone, no matter their role, rolls up their sleeves and gets things done.