Associate Director/Clinical Trial Leader

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

Company Background

MorphoSys is dedicated to the discovery, development and commercialization of innovative therapies for patients suffering from serious diseases, with a focus on cancer. Living up to the origin of our name - Metamorphosis - we have embarked on an ambitious transformation from a leading R&D company to a fully integrated biopharmaceutical company with an approval for a breakthrough cancer therapy.

Over the last two decades, MorphoSys 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.
 
Headquartered in Planegg, near Munich, Germany, MorphoSys, including the fully owned U.S. subsidiary MorphoSys US Inc. in Boston, MA, has 600+ employees.
 
Learn MOR at www.morphosys.com or www.morphosys-us.com.

Job Summary & General Responsibilities

Position Responsibilities:
  • 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 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, Experience & Skills

  • BS required in a life science discipline (i.e. Biology, Chemistry); MS, PharmD, or PhD highly desired
  • Industry and/or CRO experience is required
  • 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
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