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Clinical Trial Leader

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Job Summary

MorphoSys is a biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for people living with cancer and autoimmune diseases. 
 
Over the last two decades, MorphoSys has forged partnerships with many of the leading global pharmaceutical companies. Together with our global partners, we have developed more than 100 product candidates, of which 27 are currently in clinical development – one of the broadest pipelines in the industry.
 
In 2021, Constellation Pharmaceuticals Inc., became a fully owned subsidiary of MorphoSys. Constellation Pharmaceuticals Inc., is a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics.
 
Headquartered near Munich, Germany, the MorphoSys Group, including the fully owned U.S. subsidiaries MorphoSys US Inc. and Constellation Pharmaceuticals, Inc., has more than 750 employees. For more information visit www.morphosys.com or www.morphosys-us.com or www.constellationpharma.com We are #BolderAndBrighterTogether!

General Accountabilities

  • Leads Clinical Trial Team (CTT) in operationalizing protocol and driving protocol to advance the progress of successful clinical trial execution
  • Creates trial level timelines and ensures all trial deliverables are fully executed t with high quality on time and within budget
  • Ensures all trial related documents including operational plans and systems (e. g. clinical database, IRT, etc.) required for Ethics/Regulatory submissions and trial initiation are developed by the CTT and vendors within the specified timelines
  • Manages trial allocation and coordination/management of activities leading to the selection and initiation of sites
  • Ensures trial-level and site-level readiness for first site initiation
  • Prepares, implements and manages vendors including their sub-contractors and ensures oversight of trial activities outsourced to vendors in collaboration with CTT
  • Manages and coordinates Investigational Medicinal Products (IMP) and non-drug supplies across regions and countries and ensures final drug accountability
  • Collects, tracks, and communicates trial status for enrolment, timelines, data entry / queries, trial materials; provides updates to relevant internal / external boards
  • Manages trial budget including completion of grant plan specifications, obtains relevant internal board approvals, revises budget when applicable, and reconciles at trial close out
  • Collaborates with CTT to define the scope of responsibilities of operational and medical/clinical data review within the data management plan, or equivalent, to ensure ongoing quality data review
  • Ensures inspection/audit readiness including trial master file documentation

Job Qualifications

  • BS required in a life science discipline (i.e. Biology, Chemistry); MS, PharmD, or PhD
    highly desired
  • 7+ years of Clinical Trial operational experience in planning/executing/reporting
    clinical trials
  • Thorough & working knowledge of Good Clinical Practice, regulatory processes, and
    clinical development process
  • Flawless execution skills and high level of attention to detail
  • Superior clinical document writing skills having authored specific clinical trial related
    documents, or portions thereof, including clinical protocols
  • Exceptional cross-functional collaboration skills
  • Ability to lead meetings, drive agenda, establish clear objectives & expectations with
    others
  • Ability to influence behaviors of others without direct line responsibility
  • Experience leading health authority inspections (FDA and/or EMEA) preferred
  • Demonstrated ability to effectively manage trial budget
  • Strong leadership and project management skills
  • Excellent negotiation and conflict resolution capabilities
  • German as a second language, fluent or conversational, desirable
Health & Safety
  • 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.

EEOC Statement

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.