Vice President Clinical Operations

Vice President Clinical Operations

Affimed

Heidelberg, Germany

Responsibilities

  • Lead the clinical operations team, including line management and group leader responsibility;
  • Definition, development, implementation, and continuous improvement of the processes within clinical operations;
  • Appropriate strategic planning to ensure present and anticipated future needs can be met;
  • Establish and maintain optimum working practices to ensure timely and efficient delivery of clinical development programs and studies;
  • Operational oversight of all clinical activities, actively contribute to, lead, and guide the team covering the clinical operations activities;
  • Plan clinical studies world-wide of all phases within Clinical Development Plans;
  • Secure time- and budget-compliant and high-quality execution of the clinical program of different compounds, including strategic clinical operational planning;
  • Manage and contribute the development of core documents, including definition of timelines and milestones; preparation of clinical documents (e.g. project plans, protocols, informed consent forms, study manuals, documents for regulatory agencies or ethics committees), standard operations procedures, guidelines, and departmental policies;
  • Support internal and external CMC activities including planning of IMP logistics;
  • Develop new SOPs and periodically revise existing SOPs, as needed; work in collaboration with the clinical, cross-functional and QA team to define and develop internal processes;
  • Identify facilities and investigators to be used as clinical trial sites and build effective relationships with trial site staff;
  • Implement and execute in a timely manner and to a high standard, all aspects of clinical studies and programs in compliance with all applicable regulations, ICH guidelines, GXP and SOPs; Ensuring ethical and regulatory requirements are met;
  • Manage and oversee external contractors to ensure adequate service provision including screening, selection, support for qualification, budget and contract negotiation with service providers (CROs, vendors, service providers and consultants) also acting as escalation level for solution- and performance-oriented communications;
  • Plan, allocate, control and oversee the clinical operations cost center budget as well as individual program budgets.

Requirements

  • Strong scientific background;
  • M.Sc. in life sciences or healthcare related field, PhD in life sciences preferred;
  • At least 10 years of experience in Clinical Development, Clinical Operations and Global Trial Management including team and line management leadership roles;
  • Profound clinical development experience in oncology, ideally also covering the field of hematological malignancies;
  • Deep knowledge of GXP, project management, line management, resource management and budget planning and control -Clinical project and program management skills and ability to lead and manage performance in a dynamic environment;
  • Deep knowledge of design, set-up, conduct and reporting of clinical studies, including a thorough understanding of cross-functional clinical processes;
  • Profound knowledge of GCP, ICH and international regulations governing the conduct of clinical trials;
  • Experience in generation and control of substantial budgets;
  • Experience in leading global teams;
  • Self-motivated, pro-active and a team playing personality;
  • Profound communication skills in English, both written and oral.

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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