Affimed (Nasdaq: AFMD) is a clinical stage biopharmaceutical company which engineers targeted immunotherapies, seeking to improve patient outcomes through the power of innate immunity. Affimed’s fit-for-purpose ROCK® platform allows innate immune engagers to be designed for specific patient populations. We are developing single and combination therapies to treat cancers.

To strengthen our highly motivated Clinical Operations Team in Heidelberg, Germany, we are looking for a

Clinical Operations Program Manager (f/m/d)

(Reference No. C2104)

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Responsibilities

  • Provide operational direction and oversight of a clinical development program including timelines, quality and budget/resources
  • Lead and oversee the implementation of clinical development program for assigned compound; implement and execute to a high standard all aspects of assigned clinical program
  • Represent Clinical Operations in a compound-specific cross-functional Program Team
  • Provide operational input into the generation of Clinical Development Plan (CDP), updates thereof as well as scenario planning
  • Provide leadership to and serve as the line manager to a group of Clinical Trial Manager(s) and/or Clinical Trial Assistant(s) to support all aspects of clinical trial management of respective clinical program(s)
  • Manage, oversee, and build effective relationships with external contractors, such as CROs and other third-party vendors to ensure adequate service provision in clinical trial execution, this includes first level of escalation in case of major issues that cannot be handled at the trial team level as well as the evaluation, auditing, comparison of cost proposals and final selection of service providers, provide oversight and addressing of issues and challenges at program level
  • Build and monitor the clinical program budget in close collaboration with the Clinical Trial Managers for their clinical trial budget and clinical development team for all program clinical activities
  • Prepare and deliver presentations of trial data and progress to the cross functional program team and to upper management; help prepare presentations and summary reports to the management
  • Establish and maintain optimum working practices to ensure timely and efficient delivery of clinical development program and its studies in close collaboration with other Clinical Operations Program Managers and Head of Clinical Operations

Requirements

  • BS in life sciences or a healthcare related field, MS or Ph. D. is preferred
  • Profound Clinical Development experience including: Oncology, Clinical Project Management, GCP and international regulations
  • Proven leadership and people management skills
  • Strong knowledge of marketing authorization application process
  • Experience in providing operational input into program strategy and CDP and scenario planning
  • At least 10 years of experience in clinical operations
  • At least 8 years of experience in global trial management and oversight
  • At least 2 years of experience in global clinical program management including clinical budget responsibility
  • Clinical project and program management skills and ability to lead and manage performance in a dynamic environment
  • Deep knowledge of design, set-up and conduct of clinical studies, including a thorough understanding of cross functional clinical processes
  • Background and experience in oncology drug development and in the management of clinical studies and programs incl. budget planning
  • Strong leadership skills and experience in leading a cross-functional clinical team including internal team members as well as external representatives
  • Excellent and effective communication (written and oral) and presentation skills; fluent in English
  • Experience in line management
  • Ability to apply problem solving techniques to resolve complex issues, and apply a risk management approach to identifying and mitigating potential threats to the successful implementation of a clinical program
  • Demonstrated ability to lead and align teams in the achievement of trial and program milestones, demonstrated capability of working in an international environment
  • Broad experience in management and oversight of CROs and other service providers
  • Profound skills in negotiating contracts and budgets with CROs and other service providers

Opportunity

The successful candidate will have the unique opportunity to work in a dynamic, highly motivated, multidisciplinary, and collegial team.
For any queries, please contact Susanne Hering (Tel: 06221 6743 675, e-mail: s.hering@affimed.com).

February 2021

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