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 team in Heidelberg, Germany, we are looking for a

Medical Director (f/m/d)

(Reference No. C2101)

Apply now

Responsibilities

  • Provide clinical expertise to the cross-functional program team and clinical development team
  • Contribute to provide line of sight into unmet medical needs, clinical development strategies and clinical development plans to support the development of bispecific antibody program
  • Contribute to ensuring overall safety of the assigned clinical program in collaboration with safety/CROs by participating in safety review meetings within Affimed and with the clinical investigators, and communicating regularly/frequently with clinical investigators
  • Design clinical study protocols and define safety monitoring plan and go/no go criteria for proof of concept studies and potentially, registrational studies, in collaboration with the Senior Medical Director, clinical development team, and cross functional project team
  • Provide medical and scientific input and contribute to clinical sections of trial and program level documents (including but not limited to Investigator’s Brochures, informed consent forms, DSURs, clinical sections of INDs, regulatory briefing books, etc.)
  • Support in-/out-licensing business development activities, etc. as needed
  • Serve as study director and medical monitor for clinical trials by:
    • Performing ongoing data reviews, and leadership of safety review meetings
    • Visiting clinical study centers as needed to build/maintain relationships with study staff personnel and ensure their adequate training
    • Reviewing, analyzing and interpreting study data
    • Preparing clinical study reports, abstracts and manuscripts for publication of clinical results, in collaboration with the clinical team

Requirements

  • Medical Doctor (MD) or equivalent medical degree with specialty training and board certification in internal medicine or pediatrics
  • Subspecialty training in medical or pediatric hematology/oncology or related field, with board certification preferred
  • 2+ years of clinical research experience in hematological malignancies or oncology within academia or pharmaceutical industry including 1+ years of experience as a medical monitor of early phase clinical trials
  • Good knowledge of GCP and regulatory requirements
  • Good knowledge of biostatistics and clinical pharmacology
  • Strong leadership competencies
  • Strong interpersonal and communication skills, including ability to give presentations to a large audience
  • Strong writing skills
  • Professional working proficiency in English

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).

January 2021

Your application

    This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.