Senior 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 along with a focus on our customers. We are dedicated to bringing breakthrough medicines in oncology to market to help address unmet needs for patients with serious diseases. By applying our proprietary technologies, MorphoSys has become a world 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.  For example, we recently entered into a global collaboration and license agreement with Incyte Corporation to further develop and commercialize MorphoSys' lead investigational asset.
 
The product pipeline, one of the broadest in the biotech industry, includes over 100 distinct investigational drugs, and more than 25 therapeutic antibodies in clinical trials.  This foundation combining high science and innovative technology elevates the standards for how antibodies will be made in the future enabling their use as research, diagnostic, and therapeutic tools.
 
Through specific in-licensing and co-development activities of our own, and in conjunction with our partners, the company is adding higher value programs to the pipeline at a significant rate. Our comprehensive partnering strategy is an important feature of our business model, and a vital source of MorphoSys' financial strength.
 
To advance the development of Tafasitamab and in preparation for its planned commercialization MorphoSys founded MorphoSys US Inc., a wholly owned subsidiary of MorphoSys AG, and raised independent funding by successfully closing an IPO on the Nasdaq U.S. stock exchange in April 2018.  Our focused, controlled growth and commercialization journey has been substantial starting in 2018 with our US IPO and culminating in our Incyte Corporation partnership in 2020.  These three years have been important for MorphoSys as we continue to strive to deliver innovative medicines to patients who need them. The company is realizing our goal of becoming a fully integrated global biopharmaceutical company.
 
Tafasitamab 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. Tafasitamab received a 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 published the final L-MIND data in May 2019, and filed the BLA for Tafasitamab with the FDA in December 2019 which got accepted on March 2nd, 2020 with a priority review status.  The BLA acceptance letter from the FDA also included a target PDUFA (Prescription Drug User Fee Act) date of August 30, 2020.

Job Summary & General Responsibilities

Key Responsibilities
  • 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

 
  • MD
  • Minimum 7-10 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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