Senior Global Program Medical Director / VP, Global Clinical Program Head

    Boston, MA, US
470 Atlantic Avenue, 14th Floor
MA 02210 Boston, MA
Vereinigte Staaten

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.

Job Summary & General Responsibilities

 
General Accountabilities
  • Responsible for developing and executing the Clinical Development Plan (CDP) for >=1 indication of the proprietary tafasitamab development program at MorphoSys
  • Lead and supervise a team of Medical Directors/Medical Scientists in the department of Clinical Development
  • Support the building of the Clinical Development function in Boston, if applicable
Major Accountabilities
  • Provide strategy and input to the Global Program Team and other teams on behalf of the Clinical Development function
  • Generate and execute the indication specific tafasitamab Clinical Development Plan Develop and (co-)author high quality, feasible, comprehensive state-of the art study synopses and protocols and, in close cooperation with Clinical Operations and the responsible Medical Director/Clinical Scientist, oversee clinical study conduct
  • Supervise Medical Directors/Medical Scientists in Clinical Development during study set-up and conduct of the study to ensure operational feasibility, continuous state of the art medical monitoring, medical management of investigative sites and inspection readiness at all times
  • Lead the  preparation of clinical/medical content  for corresponding  regulatory filings In close cooperation with Regulatory Affairs help to coordinate the contributions of other functions to the documentation, as well as interaction with regulatory authorities & payer/HTA bodies
  • Support the medical and commercial organization with necessary content 
  • Develop the indication specific CDP for tafasitamab (including concept sheets, synopses and protocols derived therefrom, as well as e.g. practical and concise IDMC or imaging charters, any other associated documents) in collaboration with Medical Directors/Medical Scientists and other CDO functions; as appropriate obtain company endorsement for it during Scientific Forum, Protocol Review Committee or respective board meetings
  • Achieve high quality of trial data through dedicated and expert medical monitoring, supervision of internal and external monitoring, training and feedback to internal and external staff
  • Strive to keep protocol deviations of medical nature to the minimum by steady clinical monitoring activities
  • Contribute medical expertise and strategical considerations to the execution of clinical trials in the respective indication, e.g. regarding appropriate geographical coverage or optimum selection of investigators/study sites or development of well­ designed feasibility questionnaires
  • Supervise Medical Directors/Clinical Scientists in clinical development in such a way that they provide optimum medical management of investigative sites or IDMCs or Steering Committees as applicable, further foster quality of medical documentation including filing to be inspection ready at all times.
  • In a timely manner, together with the responsible Medical Director/Clinical Scientist prepare for trial read outs, interpret trial results, generate key messages and publish the results in collaboration with other CDO functions such as Biostatistics & Data Management and Pharmacovigilance
  • Provide clinical research expertise to support other departments and line functions (e.g. interact with Clinical Pharmacology, Risk Management, Legal, Finance)
  • Build or foster relationships within the appropriate clinical/scientific community Support Key Opinion Leader management, gather suitable medical experts to support program progress Organize effective Scientific Advisory Boards, as needed
  • As compound specific expert, support KOLs to develop sound scientific and clinical trial proposals
  • Evaluate the scientific merits of proposed Investigator Initiated Trials (IIT) in collaboration with Medical Affairs
  • Contribute medical /scientific expertise and strategy to essential documents e.g. the Investigator Brochure, deliver input to INDs, annual reports, Health/Competent Authority briefing books and submissions for clinical trials as well as marketing authorization applications
  • Write or review abstracts/manuscripts, etc. for presentation/publication at internal/external high rank meetings and support their placement in high impact journals
  • Establish, maintain and leverage an international network of key opinion leaders for the given therapeutic area
  • Prepare training materials for internal and external use as required for the respective stakeholders
  • Remain up-to-date with current information on applicable regulations, guidelines, and practices, e.g. any relevant GxP area, as well as therapeutic area knowledge Collaborate across all relevant functions like Discovery, Preclinical Development, Clinical Development, Clinical Operations, Commercial, Business Development & Portfolio Management, Intellectual Property, Pharmacokinetics & lmmunogenicity, etc. for compound specific indication selection and outline of the development path

Job Qualifications, Experience & Skills

  • This position requires an MD or MD/PhD in Life Sciences.
  • Patient treatment experience in clinical medicine, preferably in hematology and/or oncology.
  • He/she should have at least 7 years hands-on experience in clinical development, either in pharmaceutical or biotech industry.
  • We seek a professional with a track record in drug development spanning clinical phases 1-4, with focus on late stage development, including design, conduct, analysis and reporting/publishing of clinical trials
  • The responsibilities of the position also require experience in interactions with Health Authorities, with emphasis on FDA/EMA
  • Medical/scientific and state-of-the-art clinical research knowledge in the assigned area Adequate experience in all aspects of the drug development process
  • Profound knowledge of GCP and regulatory requirements related to the assigned area Expert knowledge in clinical trial design from Phase 1 through 4, including statistics and pharmacokinetics
  • Experience with health authority meetings
  • Proven ability to interpret efficacy and safety data relating to assigned area. Knowledge in interpretation of correlating data (biomarkers and clinical efficacy and/or safety)
  • Expert medical-scientific writing skills Excellent line management capabilities
  • Strong scientific standing in the respective medical community
  • Excellent oral and written communication skills Advanced presentation skills
  • Proactive, dynamic personality combined with a team player attitude
  • Proven flexibility and ability to manage, motivate and guide people in complex matrix structures and diverse cross-cultural environments
  • Highest ethical and quality standards
  • Analytic thinking skills and dedicated work mentality
 
 
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