Associate Director, Medical Operations

Associate Director, Medical Operations

Biogen Idec

Ismaning, Germany

Job Description

The Associate Director Medical Operations oversees, coordinates and optimizes medical processes of all medical units while aligning with regional/global functions. This includes the development, implementation and management of medical strategic initiatives, governance and management of Medical Information, Local Study and Publication process, financial oversight of medical budget, medical SOPs and provison of tools to measure and track medical activities, generation of a consolidated monthly medical report.

The Associate Director Medical Operations ensures that the overall objectives and tasks of the medical department are aligned wit business goals and comply with local and company policies/regulations ensuring inspection readiness.

Process development & optimization

  • Continuous gap analysis complying with local and regional/global policies;
  • Development and monitoring of metrics/KPI’s to measure & improve medical activities;
  • Generation of planning tools (MSL Plan, FTE allocation, …) and management reports (e.g. project tracker, monthly reports, …);
  • Consistently ensuring a seamless crossfunctional interface (Medical, Marketing&Sales, Market Access, PV; GCO and Regulatory);
  • SOP & Working practice development;
  • Coordination of medical process trainings;
  • Coordination of seamless inspections/audits.

Study and publication management

  • Ensuring compliance with local and global policies;
  • Supporting study implementation (conduct of due diligence of CRO selection, serving as primary contact for CRO during the study);
  • Tracking and monitoring of study activities, provide regular updates on study progress;
  • Coordinating publication management;
  • Tracking and archiving publications.

Medical Information

  • Establishing and maintaining of tools to understand time needed for individual activities;
  • Definition of time needed to perform individual tasks based upon industry experience;
  • Evaluating time allocation for top projects of company;
  • Challenging resource needs on a regular basis;
  • Alignment with global medical information process.

Budget overview

  • Oversight and adjustment of medical budget according to IPP aligning continously medical units and finance department;
  • Coordination of Medical and IPP planning process.

Strategic initiatives

  • Development of local strategies for Medical aligned with global/regional strategies;
  • Development and implementation of new digital communication channels.

Qualifications

  • Minimum of 6 years line management experience;
  • Min 6 years’ experience (in larger affiliates 6+ years) within a medical affairs role in:
    • Pharmaceutical industry or medical sector (Prior experience in Neurology, Immunology/Dermatology and/or Hematology preferred).
  • Knowledge and understanding of disease area, local health care system/market dynamics, regulations, policies and SOPs, health economic techniques and trends;
  • Broad experience in interaction with health authorities.
  • Demonstrated strategic approach to implementation of scientific communication programs on disease areas and treatments;
  • Demonstrated ability to build a team and develop a high performing organization;
  • Has demonstrated leadership skills and acquired knowledge and skills/competencies to the degree expected at job level education.

Education

  • Required - Master degree in Pharmacy, MD;
  • Desired - PhD, PharmD, DNP in medical specialty.

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Biogen Idec     Germany     Manager and Executive     Medical     Medical Advisor     5 Years+ Experience    

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