Clinical Trial Leader (gn)

 MorphoSys AG  Planegg Raum München
MorphoSys’s mission is to make exceptional, innovative biopharmaceuticals to improve the lives of patients suffering from serious diseases. Innovative technologies and smart development strategies are central to our approach. Success is created by our people, who focus on excellence in all they do, collaborate closely across disciplines. We all are driven by a desire to make the medicines of tomorrow a reality. Guided by mutual respect and trust, each member of the MorphoSys team is given the opportunity to develop and flourish within this exciting and inspiring environment. Join us in Planegg near Munich!

We would like to fill the following vacancy as soon as possible:

Clinical Trial Leader (gn)

Your Responsibilities:

  • Leads Clinical Trial Team (CTT) in operationalizing protocol
  • Creates trial level timelines and ensures all trial deliverables are met with high quality on time and within budget
  • Ensures all trial related documents including operational plans and systems (e. g. clinical database, IRT and 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 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 the 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 enrollment, 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

Your Requirements:

  • Ideally min. five years operational experience in planning / executing / reporting clinical trials
  • Thorough knowledge of Good Clinical Practice, regulatory processes, and clinical development process
  • Experience with health authority inspections (FDA and/or EMEA) preferred
  • Demonstrated ability to effectively manage trial budget
  • Strong leadership and project management skills
  • Excellent in negotiation and conflict resolution
  • Fluent English (oral and written)

We offer:

  • Creative working in X-functional teams
  • Open and respectful corporate culture
  • Multicultural environment
  • Working in an attractive, state-of-the-art building with in-house restaurant
  • Free sports and language courses

Thank you for your interest!

We are looking forward to receiving your pertinent application docu­ments. For your application please use exclusively our career portal www.morphosys.com/careers/job-opportunities. We offer not only excellent career prospects, but also support you from the very beginning – even helping you move if necessary.

MorphoSys AG, Semmelweisstraße 7, 82152 Planegg

While applying for the job please refer to jobvector

About MorphoSys AG

MorphoSys’s mission is to make exceptional, innovative biopharmaceuticals to improve the lives of patients suffering from serious diseases. Innovative technologies and smart development strategies are central to our approach. Success is created by our people, who focus on excellence in all they do, collaborate closely across disciplines. We all are driven by a desire to make the medicines of...
More about MorphoSys AG