Director, Medical Affairs

Stellenbeschreibung

Company Background

MorphoSys is focused on creating significant value for all of its stakeholders through a strategy that balances short- and long-term growth potential. By applying its proprietary technologies, MorphoSys has become a leader in the field of therapeutic antibodies. The company has established successful and lasting partnerships with industry-leading companies from the pharmaceutical and biotechnology sectors. The product pipeline, one of the broadest in the antibody industry, proves the sustainable quality of MorphoSys' work. Through specific in-licensing and co-development activities, the company is adding higher value programs to the pipeline at a significant rate. Their comprehensive partnering strategy is an important feature of their business model and a vital source of MorphoSys' financial strength.
 
2018 was an important year for MorphoSys. The company took a large step toward their goal of becoming a fully integrated biopharmaceutical company.

Tafasitamab (MOR208) is an investigational Fc-engineered therapeutic antibody targeting CD19 that is in development for the treatment of B cell malignancies. The focus of the development program is on relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), a particularly aggressive form of lymphoma, for which there are no approved treatments. Tafasitamab received breakthrough therapy designation (BTD) from the FDA in 2017 based on preliminary data from the phase 2 L-MIND study, which is evaluating the safety and efficacy of Tafasitamab in combination with lenalidomide. MorphoSys has publicly disclosed the final study data in May 2019, which will be presented at ICML and be used to support the BLA filing scheduled at the end of 2019.

To advance the development of Tafasitamab and in preparation for its planned subsequent commercialization, MorphoSys has founded MorphoSys US Inc., a wholly owned subsidiary of MorphoSys AG. An additional important step in order to increase the U.S. footprint was the successful closing of an IPO on the Nasdaq U.S. stock exchange in April 2018.

Job Summary

  • Represent Medical Affairs in cross-functional teams including launch/life cycle team
  • Support launch activities for hemato-oncological antibody therapy:
    • Work closely with Clinical Development as well as life cycle team to support the execution of the launch strategy, ensuring internal and external launch readiness
    • Support adaptation of training and other scientific material in collaboration with Marketing and other appropriate internal stakeholders
    • Develop scientific education and in-house training for MSLs and other appropriate staff as required
    • Coordinate congress reporting and summaries, collect data on competitors and market development
    • Review and critically appraise scientific literature to provide support and advice to medical and marketing groups Adhere to and advise on compliance requirements, including prudent interpretation of the Code of Practice
  • Scientific Engagement:                
    • Support Morphosys' development of positioning as a scientific authority in Non Hodgkin Lymphoma
    • Support development of KOL advocacy through provision of scientific and clinical information
    • Build strategic partnerships with KOL to ensure that Morphosys' portfolio is appropriately positioned in treatment guidelines and protocols through the provision of balanced, scientific information.
    • Ensure HCP and educational activities are of a high scientific quality and standard
    • Preparation of tailored clinical data packages for advisory boards, investigators and other key opinion leaders' request to deliver scientifically credible messages
    • Provide guidance regarding appropriate speakers for national/international congresses and workshops in order to expand and enhance legitimate scientific exchange
  • Data Generation and Publication Planning:        
    • Develop and implement publication plans
    • Facilitate and support the conduct of investigator-sponsored work (IST/IIT). Support the approval and implementation of these projects in line with relevant pharmaceutical regulations and internal SOPs as appropriate.
    • Develop and execute phase IV and observational studies

Job Qualifications, Experience & Skills

Requirements:
  • MD, PhD. or Pharm.D.
  • Minimum 3-5 years relevant experience required, prior knowledge of Hematology or Oncology is preferred
  • Experience in launching new products and launch readiness activities a distinct advantage
  • Experience in implementing Medical Affairs plans
  • Strong analytical and problem-solving capabilities
  • Excellent organizational and time management skills with the ability to work independently and coordinate workload, under pressure and in a team environment to meet established deadlines
  • Experience in working in matrix organizations, with readiness to take on work beyond your job description
  • Team player with well-developed interpersonal abilities
  • Excellent written and oral communication skills in English, including grammatical/technical writing  and presentation skills
Location
  • Boston, MA
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