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.

For our Clinical Team in Heidelberg, Germany, we are looking for a

Head of Drug Safety (f/m/d)

(Reference No. C2002)

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Responsibilities

  • Assume responsibility for all aspects and processes related to drug safety, including the collection and processing of safety relevant data in clinical studies, signal detection, reporting to competent authorities and management of safety surveillance plans
  • Serve as the safety leader for multiple clinical stage bispecific antibody programs (Phase 1 to Phase 2/3 registrational studies), providing expertise in developing and implementing safety management plans and in the ongoing assessment of safety and benefit-risk profiles of Affimed’s clinical stage molecules to the clinical development teams and cross-functional program teams
  • Establish and lead safety teams for each clinical program, including the medical monitors and safety physicians (in-house and CRO medical monitors and safety physicians), and establish SOPs related to patient safety and the ongoing safety and benefit risk evaluations of the clinical programs
  • Provide oversight to the safety CRO staff and participate in ongoing safety data review, analysis and interpretation of safety data
  • Organize and lead monthly safety review meetings for each of the clinical stage programs, revise safety management plans in collaboration with the clinical and safety teams as needed to ensure patient safety, and document decisions made
  • Provide safety summaries and benefit/risk evaluations of clinical programs in the relevant sections of clinical and regulatory documents (e.g., clinical study protocols, informed consent forms/patient information sheets, investigator brochures, clinical sections of INDs, CTAs, DSURs)
  • Communicate with health authorities, IEC/IRB, and clinical experts/advisors as appropriate in support of the safety aspects of the clinical programs
  • Review all aspects of safety within clinical study protocols and investigator brochures; work closely with the medical monitor(s) to define eligibility criteria, safety management plans, dose modification guidelines and stopping rules
  • Visit clinical study centers as needed to ensure training and compliance with safety monitoring plans on an as needed basis
  • Review safety results within clinical study reports, abstracts and manuscripts for publication, in collaboration with the clinical team

Requirements

  • Medical degree, clinical experience in pediatric or medical hematology and/or oncology preferred
  • 5+ years of experience as a Global Safety Physician in Pharmacovigilance that includes experience working in Oncology Pharmacovigilance
  • Experience in writing and evaluating individual case safety reports, analyzing pre & post marketed literature, conducting signal detection and evaluation, drafting and evaluating Risk Management Plans (RMPs), and drafting and reviewing aggregate reports (DSUR, PSUR, PADER)
  • Experience in setting up and maintaining Pharmacovigilance System Master Files (PSMF)
  • Expertise in Good pharmacovigilance (GVP) modules, ICH, AMG, EMA directives and principles of patient safety
  • Good knowledge of GCP and regulatory requirements
  • Strong leadership competencies
  • Strong interpersonal and communication skills, including ability to give oral presentations
  • Strong writing skills
  • Fluent in English; comfortable with writing clinical/scientific documents and conducting day to day meetings in English, some knowledge of conversational German is a plus

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).

June 2020

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