At MorphoSys, we are motivated by our mission: More life for people with cancer. As a global, commercial-stage biopharmaceutical company, we are driven by the urgency to discover, develop, and deliver groundbreaking medicines, aspiring to redefine how cancer is treated.
Our success is created by our people, and we bring together exceptional talent from around the world, offering our colleagues a collaborative, flexible, and diverse work environment. We are looking for individuals who share our values and are motivated to improve the lives of people impacted by cancer.
Since opening our U.S. office in Boston in 2019, we have doubled in size to support our rapid growth, building teams of experts across a variety of different disciplines, from drug development to commercialization.
To learn more, visit us at www.MorphoSys.com, and follow us on Twitter and LinkedIn.
Job Summary & General Responsibilities
Pelabresib (CPI-0610) is an investigational selective small-molecule designed to promote anti-tumor activity by inhibiting the function of bromodomain and extra-terminal domain (BET) proteins to decrease the expression of abnormally expressed genes in cancer. Pelabresib is currently being investigated in clinical phase 2 and phase 3 as a treatment for myelofibrosis and in other cancers.
- Report into the Global Clinical Program Head of Pelabresib
- Be responsible for developing and executing the Clinical Development Plan (CDP) for ≥ 1 indication in an cancer development program at MorphoSys
- Lead and supervise a small team of Medical Directors/Medical Scientists in the department of Clinical Development
- Support the building of the Clinical Development function in Boston
- 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 CDP
- 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 overseeing clinical study conduct
- Build or foster relationships within the appropriate clinical/scientific community
- Organize effective Scientific Advisory Boards, and establish, maintain and leverage an international network of key opinion leaders for the given therapeutic area
- Write or review abstracts/manuscripts, etc. for presentation/publication at internal/external high rank meetings or congresses, support their placement in high impact journals
- Supervise Medical Directors/Medical Scientists in Clinical Development during study set-up and conduct to ensure operational feasibility, continuous state of the art medical monitoring, medical management of investigative sites, inspection readiness at all times
- Lead the preparation of clinical/medical content for corresponding regulatory filings
- Work closely with Regulatory Affairs to help coordinate the contributions of other functions to the documentation, as well as interaction with regulatory authorities & payer/HTA bodies
- Support the medical & commercial organization with the necessary content
Job Qualifications, Experience & Skills
Health & Safety
- Preferably a Physician with medical degree or alternatively a PhD with substantial experience in clinical development
- Strong background in hematologic cancers, preferably Myeloid disease, and myelofibrosis
- Patient treatment experience in clinical medicine, preferably in, hematology and/or oncology
- Track record in drug development in clinical phases 1-4 with focus on late stage, preferably within Myelofibrosis or Hematology and small molecule drugs
- Development including design, conduct, analysis and reporting/publishing of clinical trials
- Experience in interactions with Health Authorities (with emphasis on FDA/EMA), ideally experience in a FDA NDA
- Successful team leadership and people management
- Demonstrated leadership in context of a global phase 3 study and close cooperation with major functions: e.g. Medical, Clinical operations, Regulatory, Drug safety
- Experience in building up department structures is a plus
- Proactive, dynamic personality, yet a team player
- Dedicated, enthusiastic, analytical
- Strong leadership skills, able to motivate and train other Clinical Development personnel to exploit their full capabilities
- Willingness and ability to work on a global scale
- Excellent presentation skills
Full vaccination against COVID 19 is a requirement for this position.
Culture & Benefits
As a full time employee of MorphoSys US Inc., you will receive a comprehensive benefits package consisting of medical and dental, vision, life, disability and more. We offer a competitive PTO and holiday schedule – giving you the time you need to recharge, along with a 401k retirement plan which allows you the opportunity to save for your future with an employer matching program. Our culture is a collaborative work environment and we believe the unique contributions each of us brings drives our success.
MorphoSys US Inc. is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices. We are committed to creating a diverse work environment with non-discrimination for all employees and qualified applicants without regard to race, color, religion, national origin, sex, protected veteran status or disability.